Impact of Value-Based Care on Quality of Life, Clinical Outcomes, Patient Satisfaction, and Enhanced Financial Protection among Hypertensive Patients inGhana: A Protocol for a Mixed Method Evaluation, 2024

Impact of Value-Based Care on Quality of Life, Clinical Outcomes, Patient Satisfaction, and Enhanced Financial Protection among Hypertensive Patients inGhana: A Protocol for a Mixed Method Evaluation, 2024 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Impact of Value-Based Care on Quality of Life, Clinical Outcomes, Patient Satisfaction, and Enhanced Financial Protection among Hypertensive Patients inGhana: A Protocol for a Mixed Method Evaluation, 2024 Duah Dwomoh, Gifty Sunkwa-Mills, Kwasi Antwi, Maxwell Antwi, Tobias F. Rinke de Wit This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4558011/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Hypertension remains a major public health concern in low and middle-income countries as most hypertensive patients are not adequately treated, and improper lifestyle modification and expensive and inadequate antihypertensive medications are among the few of the challenges that hinder effective hypertension management. Evidence on which hypertensive intervention is cost-effective is essential to inform strategy, policy development, practice, implementation, and resource allocation. Value-Based Care (VBC) is a healthcare delivery model that emphasizes improving patient outcomes while optimizing costs. It shifts the focus from the volume of services provided to the value delivered to patients. We hypothesize that innovative digital VBC intervention would be more cost-effective compared to standard care among individuals with poorly controlled hypertension. Methods This study in Ghana will employ a mixed-methods evaluation design, a comprehensive and thorough approach that combines quantitative and qualitative methods. The quantitative component will involve a quasi-experimental study to measure the impact of the VBC intervention on quality of life, improved clinical outcomes, patient satisfaction, and enhanced financial protection among hypertensive patients registered with the National Health Insurance Authority. We will use a difference-in-difference analytic approach and a generalized estimation equation model with cluster-robust standard errors to quantify the impact of VBC, accounting for potential confounding variables. The qualitative component will involve in-depth interviews and focus group discussions to gather insights into the experiences and perceptions of the patients, caregivers, and policymakers involved in the VBC intervention and the benefits, barriers, costs of treatment, and challenges associated with the VBC intervention. We aim to provide evidence that can significantly impact hypertension service delivery in Ghana, potentially leading to more cost-effective care for hypertensive patients. Discussions Despite the availability of safe treatment options for hypertension, most people with hypertension in LMICs do not have it controlled. There is currently a paucity of knowledge about the cost-effectiveness of VBC interventions in developing countries. This study aims to fill this knowledge gap and pave the way for more cost-effective hypertension treatment worldwide. The digital Ghana VBC intervention described in this paper is a pioneering approach to achieving safer, more consistent, and cost-effective care for hypertensive patients. Value-Based Care Hypertension Cost-effectiveness Health Insurance Quality of Life Clinical Outcomes Patient Satisfaction and Enhanced Financial Protection Figures Figure 1 Introduction There has been a significant increase in the burden of non-communicable diseases (NCDs) in sub-Saharan Africa (SSA) over the past two decades, driven by demographic, socio-economic, and environmental factors such as unhealthy diets, reduced physical activity, hypertension, obesity, diabetes, dyslipidemia, and air pollution( 1 ). Hypertension is a major public health concern that contributes substantially to the rising global trend in morbidity and premature mortality ( 2 ). It remains the leading cause of cardiovascular disease globally, and CVD remains the leading cause of death worldwide ( 3 ). It is estimated that at least two-thirds of cardiovascular deaths now occur in low- and middle-income countries (LMICs), bringing a double burden of disease to poor and developing world economies ( 4 , 5 ). Ferdinand et al.,( 6 ) showed that the highest levels of blood pressure worldwide have shifted from high-income countries (HIC) to LMICs, and the World Health Organization (WHO) estimates that the prevalence of hypertension is highest in the African region, with about 46% of adults aged 25 years and older being hypertensive compared to 35% in the Americas and other HIC, and 40% elsewhere in the world ( 4 , 7 ). An estimated 1.28 billion adults aged 30–79 years worldwide have hypertension, most (two-thirds) living in LMIC, and less than half of adults (42%) with hypertension are diagnosed and treated. It is estimated that approximately 1 in 5 adults (21%) with hypertension have this condition under control. Uncontrolled hypertension may increase the risk of stroke, myocardial infarction, cardiac failure, and renal failure, among others ( 8 ), and it accounts for approximately 9.4 million deaths annually( 9 ). It has been suggested that the prevalence of hypertension is increasing rapidly in SSA, and the estimated number of adults with hypertension in 2025 is predicted to increase to a total of 1.56 billion, with a disproportionate prevalence in developing countries, including sub-Saharan Africa, compared to high-income countries( 10 ). The prevalence of hypertension in Ghana from the medical literature varies. Some reported prevalence of hypertension ranges from 26–35%, with a higher prevalence recorded among men( 11 , 12 , 13 ). Others reported a higher prevalence of 59% ( 14 ), and it is estimated that two-thirds of the hypertensives were unaware of their condition, and approximately 50% of those with a history of hypertension on medication were controlled( 14 ). Additional studies report a very low prevalence of controlled hypertension among those who are on treatment in Ghana (approximately 3–12%)( 12 , 14 ). Risk factors of hypertension in Ghana include but are not limited to age, marital status, gender, and residence (urban, rural), consumption of table salt, salted meat, alcohol, canned meats, smoking, and psychological factors, including stress and anxiety, higher education and socio-economic status, employment, access to medical insurance, overweight( 15 , 16 , 17 ). Other factors include poor adherence to medication, inadequate health system capacity for early diagnosis due to an increasing number of patients, inequitable distribution of healthcare facilities affecting access, financial sustainability of the National Health Insurance Scheme, and delays in reimbursement of claims to facilities that affect the health system’s ability to provide timely management of hypertension( 18 ). Healthcare facilities and practitioners’ use of non-standardized and uncalibrated blood pressure measuring equipment are among the challenges reported in the medical literature( 18 ). Low providers’ knowledge of hypertension and patients’ awareness, policy-level challenges precluded nurses from prescribing or dispensing antihypertensives and licensed chemical sellers from stocking same( 19 ). Despite the benefits of hypertension management in reducing cardiovascular morbidity and mortality, evidence from the medical literature shows that the burden of hypertension remains high and control rates are poor in LMIC ( 20 , 21 ) and the SDG goal of reducing cardiovascular disease mortality by 30% by 2030 may not be met ( 22 ). There is evidence that most individuals are not adequately treated, and there is no value for money( 3 ). In particular, Health Insurance Schemes for healthcare today are based on rewarding volume, not value for the money spent( 23 ) and VBC stipulates a healthcare reform and policy change that must focus on improving health and healthcare value for patients( 24 ). VBC is a healthcare delivery model that emphasizes improving patient outcomes while optimizing costs. It shifts the focus from the volume of services provided to the value delivered to patients. This value-driven form of reimbursement has emerged as an alternative to the traditional fee-for-service reimbursement, which pays providers based on the quantity of services delivered. In the standard care system, providers deliver care services in a fragmented manner. In a value-driven care system, experience and outcome measures drive care delivery. The costs of care are not calculated per care service but per outcome achieved. The VBC model revolves around health outcomes generated in the patients, which can be determined based on specific measures, such as the reduced need for hospital readmission, improvement in health-related quality of life, better patient satisfaction, and enhanced financial protection. These measurements are used to adapt and combine care services along a patient journey (in the form of bundles) to maximize the outcomes while minimizing the costs. This study aims to implement and evaluate the impact of comprehensive value-based care (VBC) intervention on health-related quality of life, patients’ clinical outcomes, patient satisfaction, and financial protection among NHIA-insured hypertensive patients. In addition, the study will assess challenges associated with VBC intervention in providing quality and cost-effective hypertensive care at health facilities and the mitigation strategies needed to address these challenges. Study hypothesis. We hypothesized that a VBC approach to improving clinical outcomes (lowering blood pressure, improving blood sugar, body mass index, and waist circumference, improved health-related quality of life, reducing cost of care, increasing level of adherence to treatment, and reducing other risk factors), informed by detailed analysis of health system and patient-specific barriers, would be superior to standard care in individuals with poorly controlled or newly diagnosed hypertension. That is, we determined whether a VBC model that involves key stakeholders’ participation (patients, healthcare workers, NHIA, PharmAccess, and CHAG) via the provision of effective medications and a comprehensive treatment and management plan could substantially improve clinical outcomes and overall quality of life and simultaneously reduce the cost of treatment of hypertension and its complications. Intervention components In a VBC model, healthcare providers are incentivized to deliver high-quality, cost-effective care and are held accountable for the outcomes achieved. The benefits of a value-based healthcare system extend to patients, providers, payers, suppliers, and society, and VBC has the promise to significantly increase the overall health gains of the population. To chart a different trajectory and build human-centered health systems that generate better long-term value for society, the National Health NHIA, in collaboration with PharmAccess and CHAG, will implement and evaluate a VBC intervention for hypertensive patients. This VBC intervention will include different aspects of VBC as outlined in the strategic framework for value-based care implementations( 25 ). This includes interventions that focus on understanding patient needs, patient-centered solutions such as behavioral and self-management interventions and integrating monitoring and learning systems for providers. Its aim is to align the interests of all stakeholders in the health system, including patients, providers, payers, and policymakers. VBC aligns these stakeholders with a common goal: achieving outcomes that matter to patients at the optimal cost. Content of the intervention Training healthcare workers to improve their knowledge, attitude, and practices towards hypertensive care. Provision of critical medical equipment and essential medicine lists to promote the quality of hypertensive care. Promote clinician-led patient follow-up. Provide training for hypertensive patients on strategies to improve adherence to hypertensive medication and clinical outcomes. Provide incentives to healthcare workers to deliver high-quality and cost-effective care. Utilize digital technology to improve behavioral counseling programs for hypertensive patients. Provide training for patients and caregivers on self-hypertensive management. Form patient groups where they discuss and share knowledge on hypertensive management. Utilize a digital behavioral counseling program. Develop a value-based payment model. Implement an information technology program to track patients' progress. Conceptual framework Figure 1 shows the framework for testing this hypothesis. This framework, developed by the authors, is based on subject knowledge of the VBC model and a literature review of factors associated with uncontrolled hypertension. The VBC interventions (such as the behavior change program, training of health professionals, providing incentives, etc.) are expected to better meet patient needs, improving patient care experience and health behaviors. These factors will contribute to better quality of life and clinical outcomes, preventing complications and reducing the overall costs for hypertensive patients in the VBC arm of this study. Expected Outcome The study will generate evidence regarding the effectiveness of VBC intervention on hypertension management in Ghana. Methods Evaluation design The study will utilize a mixed-method evaluation design that incorporates both quasi-experimental design and qualitative design techniques to evaluate the impact of VBC on patients' clinical outcomes, health-related quality of life, and financial protection among NHIA-insured hypertensive patients visiting CHAG facilities in Ghana. This study's design is ideal compared to cluster-randomized control trials (RCT), even though RCT is more robust with minimal bias and high internal validity. However, we consider the randomization of facilities to receive VBC interventions untenable since facilities were pre-selected based on resource availability and the willingness of the facility in charge to implement VBC. To improve the internal validity of the quasi-experimental design, control facilities that share similar characteristics with the intervention facilities will be carefully selected such that there will be no systematic difference between the intervention and control facilities, and changes in health outcomes could be attributed to the VBC. Each selected intervention facility will have a control facility in the same region and at the same administrative level of the health facility (hospital, health center, etc.) to minimize bias associated with the location and the level of health facility. In addition, the same inclusion criteria for hypertensive patients would apply in the intervention and control health facilities to minimize within-patient bias. The VBC intervention will be implemented at the facility level, targeting healthcare providers and patients who are nested within health facilities and will be followed over time. A baseline survey will be conducted in all the intervention and control facilities to assess the mean and prevalence of the outcome measures and their risk factors among hypertensive patients visiting these facilities on specialized clinic days. Hypertensive patients in the controlled health facilities will receive standard care as provided during the regular clinic days. To improve the control of hypertension and save costs, the intervention facilities will receive VBC intervention programs delivered by trained intervention managers. The intervention will be given for 24 months (2 years), but a midline survey will be conducted in 12 months and at 24 months post-baseline). Study settings The study will be conducted in 32 Christian Health Association of Ghana (CHAG) accredited health facilities (hospitals and health centers) in five administrative regions of Ghana that provide services for hypertensive patients. Twenty health facilities will constitute the intervention facilities, and the remaining 12 facilities with similar characteristics to the intervention facilities will be selected within the same region as comparison health facilities to reduce the effect of selection bias that arises from quasi-experimental studies. Target population This study will involve hypertensive patients who visit CHAG facilities in Ghana's six administrative regions. It will also involve healthcare workers (hospital administrators, medical doctors, nurses, pharmacists, and laboratory technicians) and VBC implementers at PharmAccess, CHAG, and the National Health Insurance Authority (NHIA). Power analysis and sampling design We assumed that if the value-based care is effective, both systolic and diastolic blood pressure will reduce by 5 mmHg on average among patients in the intervention facilities compared to patients in the control facilities. We further assumed a power of 90% to detect a significant effect of the value-based care if it exists, type I error of 5%, attrition rate of 10%, standard deviation of 10 mmHg( 26 ), average cluster size of 20 representing the average number of hypertensive patients seen on a clinic day per visit with a coefficient of variation of cluster sizes 0.5 and a design effect of 4.6 to adjust for correlation of the outcome measure at the facility level assuming an intra cluster correlation (ICC) of 0.15. We also assumed that the correlation between baseline measurements (or other predictive covariates) and hypertension is 0.5. The estimated number of health facilities will be 32 (16 control facilities and 16 intervention facilities). Ideally, 16 control health facilities should have been selected to increase the power of the study. Today, the intervention has already been started with stakeholder engagement and training, albeit at a slow pace and intensity in 20 health facilities. This implies that of the 32 facilities, the remaining 12 can serve as a comparison group, which corresponds to 712 hypertensive patients (450 patients in the intervention facilities and 262 patients in the control facilities). On average, about 20 hypertensive patients receiving care on clinic days who meet the inclusion criteria and consent to be part of the study will be interviewed per facility. Ethical Considerations The study has secured ethical approval from the Christian Health Association of Ghana (CHAG) Ethics Review Committee, with ethics approval number CHAG-IRB01012024. CHAG is the legally mandated institution required to provide ethical approval for all health-related research in CHAG-accredited health facilities. We emphasize that study participants will not be named in any report, and we will keep their identities confidential. Electronic data will be safeguarded in a password-protected folder, and only authorized users on the study team will be able to access it. Study participant's inclusion criteria. Eligible health facilities will be CHAG-accredited health facilities providing hypertensive services for patients on clinic days. Eligible participants will comprise all consenting patients (male and female), age 18 years and above, visiting CHAG facilities on a clinic day because of past or current diagnosis of hypertension. That is, all patients visiting hypertensive clinics with the following: 1) Systolic blood pressure (SBP) ≥ 160 mm Hg is recorded at the first onsite screening. 2) SBP 140–159 mm Hg is recorded at first onsite screening, AND the participant reported a medical diagnosis of hypertension or is taking anti-hypertension medication. 3) SBP less than 140mm Hg is recorded at first onsite screening, AND the participant reported a medical diagnosis of hypertension or is taking anti-hypertension medication at the health facility. 4) Participants did not meet criteria 1–3, but SBP 140–159 mm Hg was recorded on two separate screenings at the facility within 1 hour. Exclusion criteria Participants will be excluded if they meet these criteria but are unable to participate in the study due to sickness or any other form of serious illness that makes it impossible for him/her to grant an interview, refuse to consent, concurrently participate in any other intervention-based study that would compromise the protocol of VBC, had a severe comorbid condition with life expectancy < 1 year, or factors likely to interfere with study participation or with their ability to complete the study. Dropout Participants will be considered dropouts if they are unwilling to continue their participation for any reason, withdraw due to health problems, or if someone dies within the study period. To minimize the rate of loss to follow-up during our subsequent interviews, we will select hypertensive patients who are likely to visit the same health facility for hypertensive care for the next 12 months. There will be regular follow-up reminders and incentives for continued participation. Collection of qualitative information A nested qualitative study will be conducted within the quasi-experimental design. Semi-structured in-depth interviews of key informants will be conducted to capture the perspectives and experiences of the value-based care intervention and perceived barriers and enablers faced during the implementation of the intervention, the impact of the VBC on the quality of life of hypertensive patients, etc. We will develop an interview guide based on the study objectives and previous literature to align with the research goals. Using a purposive sampling approach, data will be collected from all targeted populations, including patients, service providers (clinicians, nurses, pharmacists, laboratory technicians), PharmAccess, CHAG, NHIA, and all other relevant stakeholders. A total of 30 in-depth interviews with key informants will be conducted (15 interviews in the intervention facilities and 15 interviews in control facilities). The qualitative interviews will be truncated when we reach thematic saturation. In addition, a total of three key informants will be interviewed from NHIA, CHAG, and PharmAccess. All interviews will be digitally recorded and transcribed verbatim after translating from the local language to English. Transcripts will be reviewed through a quality assurance system for accuracy and consistency. Transcripts that are found to meet the quality standards after a thorough review will be analyzed using a thematic content analysis approach. A sample of each set of transcripts from the different targeted populations will be reviewed by the consultants. Themes based on the interview guide underpinned by the objectives will be developed with consultants coming to a consensus on where differences exist in themes. Qualitative analysis Researchers will independently code the transcripts by assigning codes to segments of text that capture key concepts and ideas. Codes will be refined and grouped into broader themes that represent the core findings of the interviews. Data will be analyzed through the framework approach ( 27 ), which embraces inductive (emerging codes) and deductive (a priori code from the utilization-focused evaluation module) methods. The framework approach involves six ( 6 ) iterative steps: ( 1 ) familiarization with the data, ( 2 ) generating initial codes or assignment of primary codes to the dataset to describe the content, ( 3 ) searching for patterns and codes across the different interviews, ( 4 ) codes revision, ( 5 ) codes definition and ( 6 ) producing the report through the interpretation of results. The inductive method will involve steps 1 and 2, while the deductive method will involve steps 3 to 6. The codes will be discussed and compiled into a codebook to guide the coding and categorization of the data. The deductive analysis approach will ensure coding data units according to evidence relating to impact, challenges, and mitigation strategies associated with implementing VBC at the health facilities. The coding process will be done in QRS NVivo version 12 to enhance the rigor and audit trail of all data coded. Training of enumerators and supervisors The training will focus on understanding the content of the data collection instrument, key objectives of the VBC project, data collection methods, ethical consideration in scientific research, code of conduct during field surveys, informed consent, communication channel, ensuring data quality, collection of GPS coordinates of the health facilities and the households, conducting interviews, checking completed questionnaires, digital data entry, and ensuring standard operating procedures are followed. Specifically, the training will involve an overview of the activity and evaluation methodology, informed consent and confidentiality, data quality assurance procedures and quality checklists, mock practices with each tool, qualitative data collection practices (facilitation, inclusiveness, probing), piloting the tool, securing data storage and transfer, common troubleshooting and daily reporting and oversight. Training will incorporate a complete review of the survey instruments and role-play to simulate real-life interview scenarios. Supervisors will also receive special leadership training skills during this period to efficiently coordinate the fieldwork activities and ensure adherence to the project timelines. Data Integration Quantitative and qualitative findings will be triangulated to better understand the impact of VBC intervention, challenges, and mitigation strategies associated with the implementation of the VBC intervention at the health facilities. Qualitative data will enrich the quantitative findings by providing an in-depth understanding of hypertensive patients and other stakeholders' lived experiences regarding the VBC intervention. With the analysis and integration of data from two sources obtained by the mixed methods approach, the findings can be corroborated, and the weakness or bias of any of the methods or data sources can be compensated for by the strengths of another, thereby increasing the validity and reliability of the results. Primary outcome measures The primary outcome measures include systolic blood pressure and diastolic blood pressure. Participants will be considered to have high blood pressure if recorded SBP ≥ 130 mmHg and/or DBP ≥ 80 mmHg( 28 )). These primary outcomes will be compared between intervention and control groups after 12 and 24 months of implementing the value-based care intervention. We will also compare the difference in mean systolic and diastolic blood pressure levels at baseline, midline, and post-intervention periods for the control and intervention groups. Blood pressure will be measured using a calibrated Omron Premium Blood Pressure Monitor Device, Omron HEM-7322 (Australia). Blood pressure will be measured from the right arm with the person sitting upright after 3 min of rest, and a further measurement will be taken following a period of at least 3 minutes of rest. If a major difference is observed between the first two measures, a third measure will be taken, and the nearest two measures will be recorded. The two readings will be averaged separately for SBP and diastolic blood pressure (DBP). Secondary outcome measures The secondary outcome measures include blood sugar level, health-related quality of life, weight and height, waist, hip circumference and waist-to-hip ratio (WHR), adherence to medication, health professional knowledge, depression anxiety, stress, and the average cost of care. Blood sugar The blood sugar level will be monitored using the HbA1c test. A normal HbA1c level is below 5.7%, 5.7–6.4% indicates prediabetes and 6.5% or more indicates diabetes. Within the 5.7–6.4% prediabetes range, the higher your HbA1c, the greater your risk of developing type 2 diabetes. Health-related quality of life The EQ-5D will be used to assess the health-related quality of life of the study participants( 29 ). It consists of five sets of questions measuring five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question is rated on a 5-point scale (1 – No problem to 5 - Unable/extreme problems). Using a value set, the individual health rating is converted to a health-rated quality of life index ranging from 0 (dead) to 1(fully healthy). The value set is a set of weights applied to each severity level in the 5 dimensions. Higher weight is applied to high severity while low weight is applied to low severity on quality of life. Weight and height This study will use the portable stadiometer (SECA, United Kingdom) with an accuracy of 1 mm to measure the heights of the participants, i.e., from the heel to the highest point of the head, will be measured. The study participants will be asked to take off their shoes during the measurement. The weight of the participants will be measured using a calibrated weighing scale to the nearest 0.1 kg. Then, the Body Mass Index (BMI) for each participant will be calculated as follows: \(weight/{height}^{2}\) . Waist, hip circumference, and WHR The waist circumference of each participant will be measured using a flexible tape to the nearest 0.1 mm. The point of measurement, i.e., above the hip bone, will be fixed for all respondents, and the respondents will be advised to relax the stomach by breathing out gently and not to suck in the tummy. The tape will be placed properly and parallel to the floor without compressing the skin. The measurement will be taken around the waistline at the end of normal expiration. The area with maximum protrusion of the buttocks on standing with the feet close together will be considered as the reference point for the hip circumference measurement. We will estimate the waist-to-hip ratio (WHR) from the values obtained from the two indicators. Adherence to hypertensive medication The Hill-Bone High Blood Pressure Compliance Scale will be used to assess the level of compliance across three behavioral domains critical for HBP care and control: 1) reducing sodium intake, 2) appointment keeping, and 3) medication taking. The scale has 14 items rated on a four-point scale from 1 – Never to 4 - All the time. The total score is computed by summing the response ratings, and the score ranges from 14 to 46. A high score is indicative of noncompliance, and a low score is indicative of compliance. Health professional knowledge A newly validated international questionnaire will be used to assess health professionals’ knowledge of hypertension diagnosis ( 30 )The tool enables objective and comprehensive assessment of medical and nursing professionals' knowledge of the initial diagnosis of hypertension. Depression, Anxiety, and Stress Depression, Anxiety, and Stress Scale (DASS-21) will be used to assess depression, anxiety, and stress among hypertensive patients. The DASS-21 is a self-report measure in which hypertensive patients will rate the frequency and severity of experiencing negative emotions over the previous week. Frequency/severity ratings are made on a series of 4-point scales (0 = did not apply to me at all, 3 = applied to me very much, or most of the time). Cost of treatment This study will use structured questionnaires to measure out-of-pocket health expenditures (direct and indirect cost) before and after VBC intervention among patients in the intervention and control health facilities. Cost of implementing VBC intervention Intervention costs for VBC in this study refer to the resources used to operate and deliver the intervention. The intervention cost of the VBC hypertension management program will include the cost of training for medical practitioners to deliver lifestyle coaching sessions, the cost of the venue for training, the cost of delivering lifestyle coaching sessions, the cost of medication, the cost of communication for providers to reach out to patients to improve adherence, cost of periodic reviews of outcomes and costs leading to continuous improvement cost of implementing and testing digital behavioral counseling program, patient tracking, and cost of training patients on self-management. Overall, the ingredients approach will be used to collect all relevant cost data. This approach means that all relevant materials and items required for implementing each activity will be quantified and valued. For example, training of healthcare providers, patients, etc. Personnel costs, including per diem for trainees, honorarium for trainers, venue, stationery, and other relevant logistics, will be costed to measure financial cost. Where relevant capital items will be costed and annualized at a 3% discount rate. Financial costs will be estimated by calculating direct medical (e.g., drugs, laboratory tests) and non-medical costs (e.g., transportation, personnel costs, etc). Indirect cost will also be measured for productivity losses to appreciate the opportunity cost of the intervention. This will include travel time, time spent in training, etc. The total economic cost is the sum of the direct and indirect costs. The study will use the health care provider perspective, payer (NHIS) perspective and societal perspective. If proven effective, the consequences of implementing this intervention include increased quality of life from patients achieving blood pressure control and savings in resources by avoiding hospitalizations that could have otherwise occurred. The following steps will be taken to micro-cost the VBC intervention. Step 1: This will involve defining the VBC processes and identifying the types of resources that are used in carrying out those processes. This step could include reviewing documents or literature, conducting a site visit, or talking to core staff. The purpose is to gain a detailed understanding of how the VBC operates and to identify an inventory list of what resources are involved and how they are used. Step 2: We will systematically measure the unit quantity of each type of resource consumed. That is, we will determine the quantity used for each type of resource identified in step 1. Step 3: Each type of resource will be assigned a unit cost, and for each resource type, the unit cost will be multiplied by the unit quantity and aggregated to find the total cost. Step 4: Finally, adjustments will be made to any assumptions, such as the value of a certain resource or assumptions that might influence the estimated quantity of resources consumed as part of the implementation of the VBC intervention, to test the robustness of the estimates and show how it might change under different sets of assumptions. Selection of comparison facilities Comparison health facilities were carefully selected to reflect the characteristics of the intervention facilities. For each intervention facility, a control facility will be selected from the same region and the same level of care as there are marked differences in the availability of qualified medical personnel, logistics (medicines and supply), and poverty across the regions. Patients in the controlled facilities will only receive the usual standard hypertensive care, and they will not receive the VBC-based intervention. Standard hypertensive care in this study refers to the usual care they receive when they visit hypertensive clinics. Potential confounders The independent variables of interest in this study include the respondent's sex, age in years, current marital status, educational level, religion, employment status, religious affiliation, valid NHIS card, study location, household size, lifestyle factors (exercise, anxiety, depression, stress and diet, alcohol and smoking), and household wealth. Data management Each participant will be assigned a unique identification number after the baseline survey. This will facilitate and reduce the errors in linking lab-based clinical outcomes to other patients' records. The research team members will develop the study tool for the baseline, midline, and endline surveys. Data collection would be done electronically during face-to-face interviews at the facility or respondent homes using Open Data Kit. Prior to the commencement of fieldwork, there will be recruitment for the positions of laboratory scientist for each health facility, field data collectors (enumerators), and supervisors. The laboratory scientist will lead the collection of all blood samples for testing. A one-week training would be organized for enumerators and field supervisors focusing more on the questionnaire's definitions of key outcome variables of interest and how to ensure data quality. The training of enumerators and supervisors will be preceded by training on the ethics of research involving human subjects. Training will incorporate a complete review of the survey instruments and role-play to simulate real-life interview scenarios. Supervisors will also receive special leadership training skills in order to efficiently coordinate the activities of the fieldwork and to ensure adherence to the timelines of the project. All interviews would be completed by small teams of enumerators led by a field supervisor. The supervisors would be responsible for monitoring the field enumerators. The enumerators, team leaders, and field supervisors would be selected based on their experience conducting longitudinal cluster randomized studies and fluency in the relevant local languages. To reduce the unit non-response rate, each enumerator would approach a household up to three times to locate respondents. In addition, the telephone number of the respondent and close relative will be obtained after informed consent to follow up with patients throughout the study. The training manual will be used throughout the training period and as a reference throughout the survey. Two days will be allocated for the pre-test of questionnaires and discussions with supervisors and enumerators to ensure familiarity and address outstanding issues arising from the pre-test at Ghana Health Service (GHS)try facilities. The study investigators will be responsible for data quality control issues handled on three different levels. The first level is the real-time logic and range checking built into the online data entry system. The second level of quality control involves the study investigators conducting real-time daily checks. Checks will identify complicated and less common errors. The third level of quality control involves local monitoring, where data in our database will be checked, and if errors are identified, research assistants who commit these errors will be identified using the system and asked to correct them before moving to the next stage of data collection. Statistical analysis Analysis and reporting of the effect of the VBC will follow the Consolidated Standards of Reporting Trials guidelines for cluster randomized controlled trials ( 31 ). The study will utilize descriptive and inferential statistics to address the study objectives. Mean, standard deviations, minimum and maximum observations, and confidence intervals will be reported for normally distributed continuous outcome measures. The median and interquartile range will be reported for non-normally continuous variables. Both graphical (histogram superimposed with a normal distribution curve) and numerical methods (Shapiro Francia and skewness and kurtosis test) will be used to determine whether continuous variables approximate normality. Categorical variables will be summarized using frequencies and percentages of each category, and the association between categorical variables will be analyzed using the chi-squared test of independence (with Yates correction for 2 × 2 tables) or Fisher’s exact test in cases where expected frequencies are low. The study will employ both parametric and non-parametric inferential statistical methods. The student’s t-test (for parametric variables) or the Wilcoxon Rank sum test (for non-parametric variables) will be used to test the hypothesis of difference in means or medians of continuous outcomes between intervention and control groups. Z-test for comparing the differences in proportion will be used to test the hypothesis of the difference in the proportion of binary outcome measures between intervention and control. To quantify the impact of the VBC intervention on the outcome measures of interest, intention-to-treat-based difference-in-difference analysis with a multivariable ordinary least square regression, quantile regression, binary logistic regression model, Negative binomial and Poisson regression models with robust standard errors will be used depending on the measurement scale of the outcome measure. The analysis of both primary and secondary outcome measures will account for the clustering effect and use a mixed effects model considering the facility as a random intercept effect. Additionally, individual-level marginal modeling (population-averaged model) using generalized estimating equations (GEEs) with an exchangeable correlation structure will be used. The consistency of VBC's impact on the primary outcome will be explored in predefined subgroups, including sex, age categories, education, region, marital status, and comorbidities. We will test whether the effects varied by subgroups using tests of interaction-based models between subgroup variables and the treatment group. All statistical analyses will be conducted using Stata MP version 17 (StataCorp. 2021. Stata Statistical Software: Release 17. College Station, TX: StataCorp LLC), and a two-sided test at the 0·05 level will be considered to be statistically significant. Final results will be expressed as mean/proportion (95% CI) in each group, and two-sided p values will be reported. Discussion The Ghanaian National Health Insurance Scheme (NHIS) rewards the volume of services provided to hypertensive patients, not the value for the money spent. We developed a research protocol to assess the cost-effectiveness of value-based care intervention for hypertensive patients. This protocol will generate evidence to shape public opinion regarding the effectiveness of value-based care on hypertension management and the possibility of policy formulation to scale up to other health facilities and eventually incorporate it into health insurance. Despite the benefits of hypertension management and the availability of safe and low-cost medications in reducing cardiovascular morbidity and mortality, evidence from medical literature shows that the burden of hypertension remains high, and control rates are poor in developing countries. Controlled hypertension is one of the priority areas identified by the WHF for action if the target of a 25% reduction in premature CVD mortality by 2025 is to be achieved( 32 ). This study aims to implement and evaluate an innovative digital VBC intervention in Ghana. Our study will assess the effectiveness of VBC on health-related quality of life, clinical outcomes, and cost of treatment. The VBC approach to healthcare allows health professionals to think differently about their role within the larger care team and the services they provide in general. For instance, in the absence of value-based care, most physicians are largely concerned with what happens in the consulting room and, in most cases, do not follow up with patients outside office hours to enquire about progress made after the first appointment. Our proposed VBC intervention starts with identifying and understanding hypertensive patients whose health and related circumstances create consistent needs relative to improved health outcomes and cost. To achieve this, the study plans to involve an interdisciplinary team of caregivers, policymakers, and patients to design and deliver comprehensive solutions to health-related challenges associated with providing quality care at an affordable cost. The research team will measure the health outcomes and costs of care for each hypertensive patient during baseline, midline, and endline data collection and use the information to drive ongoing improvements, identify challenges and mitigation strategies, and assess the impact of VBC on the selected outcome measures. VBC interventions have been shown elsewhere to improve the quality of care, lower rates for some measures of acute care utilization, and lower actual payments received by the delivery system( 33 ). Others have argued about the need to introduce regulations to end coverage and price discrimination based on health risks or existing health problems and measure and report their subscribers’ health outcomes, starting with a group of important medical conditions( 34 ). However, we need to provide evidence of the effectiveness of VBC interventions in improving the quality of care and reducing the cost of treatment to justify the need to shift focus to value-based healthcare. The health system is confronted with issues regarding the quality and cost of care, and the current payment system that encourages volume-driven care rather than value-driven care is a contributing factor( 23 ). Healthcare providers and facilities gain increased profits by delivering more services to more people, resulting in increased healthcare costs without corresponding improvement in health outcomes. VBC could mitigate the impact of factors that drive healthcare cost of hypertensive treatments, such as the prevalence of hypertension in the population (for example, how many people have hypertension), the number of times patient receives care they require per condition (for example, how many hypertension-related comorbidities a person with hypertension has); the number and types of health care services the hypertensive patient receives in each episode (for example, when a person has uncontrolled hypertension, does he or she receive heart-related treatment induced by hypertension or simply medical management?); the number and types of processes, devices, and drugs involved in each hypertensive service and finally, the prices of each of those individual processes, devices, and drugs. To the best of our knowledge, no studies have been conducted in Ghana and, to a large extent, LMIC to quantify the impact of value-based care on health-related quality of life, improved patient clinical outcomes, patient satisfaction, and enhanced financial protection among NHIA-insured hypertensive patients. This evaluation study will ( 1 ) allow us to generate evidence on the impact of VBC on the aforementioned outcome measures, identify challenges and mitigation strategies associated with the implementation of VBC interventions, ( 2 ) help to sensitize the policymakers on the need to shift from volume-driven care to value-driven care, and finally ( 3 ) allow a debate among health providers, policymaker, Civil Society Organizations and all other relevant stakeholders on the need to expand VBC to other facilities assuming the intervention prove to be cost-effective. Abbreviations CHAG Christian Health Association of Ghana GHS Ghana Health Service NHIA National Health Insurance Authority NHIS National Health Insurance Scheme VBC Value-Based Care Declarations Ethics approval and consent to participate The study has secured ethical approval from the Christian Health Association of Ghana (CHAG) Ethics Review Committee, with ethics approval number CHAG-IRB01012024. CHAG is the legally mandated institution required to provide ethical approval for all health-related research in CHAG-accredited health facilities. The study will be conducted in accordance with the ethics guidelines of the Declaration of Helsinki. Informed consent will be secured from each study participant. The participants' confidentiality will be assured by not including names or personal identifiers during data collection, analysis, and reporting and respecting the privacy of study participants during interviews. Participants' right to refuse participation, not answer any questions they don’t want to, or withdraw participation after enrolling will be fully respected. Consent for publication Not applicable Availability of data and materials Data will be made available upon reasonable request if all the necessary documentations are duly completed, and the request must be submitted through the CHAG Ethical Review Committees ( [email protected] ) Competing interests The authors declare that they have no competing interests Funding This research will be funded by PharmAccess Ghana; however, the views expressed do not necessarily reflect PharmAccess Ghana and its global partners. Authors' contributions DD, GS, KA, MA, and TFR conceptualized the study and reviewed the draft manuscript. DD designed the data collection instrument, submitted the protocol for ethical approval, and wrote the initial draft protocol for submission. GS, KA, MA, and TFR reviewed the entire protocol. All authors read and approved the final protocol. Acknowledgements We acknowledge all D&D Statistical Consulting Services Limited field enumerators who have agreed to lead the field data collection in October 2024. We also acknowledge all hypertensive patients, officials from CHAG and NHIA, and healthcare workers willing to participate in this study. References Bigna JJ, Noubiap JJ. The rising burden of non-communicable diseases in sub-Saharan Africa. Lancet Global Health. 2019;7(10):e1295–6. Akpa OM, Made F, Ojo A, Ovbiagele B, Adu D, Motala AA, et al. Regional patterns and association between obesity and hypertension in Africa: evidence from the H3Africa CHAIR study. Hypertension. 2020;75(5):1167–78. Schwalm J-D, McCready T, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas P, et al. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2019;394(10205):1231–42. Cappuccio FP, Miller MA. Cardiovascular disease and hypertension in sub-Saharan Africa: burden, risk and interventions. Intern Emerg Med. 2016;11:299–305. Nolla Solé JM. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet, 2012, vol 380, num 9859, p 2224–2260. 2012. Ferdinand KC. Uncontrolled hypertension in sub-Saharan Africa: now is the time to address a looming crisis. J Clin Hypertens. 2020;22(11):2111. Organization WH. A global brief on hypertension: silent killer, global public health crisis: World Health Day 2013. World Health Organization; 2013. Guwatudde D, Nankya-Mutyoba J, Kalyesubula R, Laurence C, Adebamowo C, Ajayi I, et al. The burden of hypertension in sub-Saharan Africa: a four-country cross sectional study. BMC Public Health. 2015;15:1–8. Bromfield S, Muntner P. High blood pressure: the leading global burden of disease risk factor and the need for worldwide prevention programs. Curr Hypertens Rep. 2013;15:134–6. Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. lancet. 2005;365(9455):217–23. Atibila F, Hoor Gt, Donkoh ET, Wahab AI, Kok G. Prevalence of hypertension in Ghanaian society: a systematic review, meta-analysis, and GRADE assessment. Syst reviews. 2021;10(1):220. Bosu WK, Bosu DK. Prevalence, awareness and control of hypertension in Ghana: A systematic review and meta-analysis. PLoS ONE. 2021;16(3):e0248137. Tannor EK, Nyarko OO, Adu-Boakye Y, Owusu Konadu S, Opoku G, Ankobea-Kokroe F, et al. Prevalence of hypertension in Ghana: Analysis of an awareness and screening campaign in 2019. Clin Med Insights: Cardiol. 2022;16:11795468221120092. Sanuade OA, Awuah RB, Kushitor M. Hypertension awareness, treatment and control in Ghana: a cross-sectional study. Ethn Health. 2020;25(5):702–16. Dai B, Addai-Dansoh S, Nutakor JA, Osei-Kwakye J, Larnyo E, Oppong S, et al. The prevalence of hypertension and its associated risk factors among older adults in Ghana. Front Cardiovasc Med. 2022;9:990616. Konlan KD, Lee H, Lee M, Kim Y, Lee H, Abdulai JA. Risk factors associated with the incidence and prevalence of hypertension in Ghana: an integrated review (2016–2021). Int J Environ Health Res. 2023;33(11):1132–47. Opoku S, Addo-Yobo E, Trofimovitch D, Opoku RB, Lasong J, Gan Y et al. Increased prevalence of hypertension in Ghana: New 2017 American College of Cardiology/American Hypertension Association hypertension guidelines application. J global health. 2020;10(2). Koduah A, Nonvignon J, Colson A, Kurdi A, Morton A, Van Der Meer R, et al. Health systems, population and patient challenges for achieving universal health coverage for hypertension in Ghana. Health Policy Plann. 2021;36(9):1451–8. Laar AK, Adler AJ, Kotoh AM, Legido-Quigley H, Lange IL, Perel P, et al. Health system challenges to hypertension and related non-communicable diseases prevention and treatment: perspectives from Ghanaian stakeholders. BMC Health Serv Res. 2019;19:1–13. Carter BL, Coffey CS, Ardery G, Uribe L, Ecklund D, James P, et al. Cluster-randomized trial of a physician/pharmacist collaborative model to improve blood pressure control. Circulation: Cardiovasc Qual Outcomes. 2015;8(3):235–43. Jafar TH, Hatcher J, Poulter N, Islam M, Hashmi S, Qadri Z, et al. Community-based interventions to promote blood pressure control in a developing country: a cluster randomized trial. Ann Intern Med. 2009;151(9):593–601. Bennett JE, Stevens GA, Mathers CD, Bonita R, Rehm J, Kruk ME, et al. NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4. lancet. 2018;392(10152):1072–88. Miller HD. From volume to value: better ways to pay for health care. Health Aff. 2009;28(5):1418–28. Porter ME, Teisberg EO. How physicians can change the future of health care. JAMA. 2007;297(10):1103–11. Teisberg E, Wallace S, O’Hara S. Defining and implementing value-based health care: a strategic framework. Acad Med. 2020;95(5):682–5. Schwalm J-DR, McCready T, Lamelas P, Musa H, Lopez-Jaramillo P, Yusoff K, et al. Rationale and design of a cluster randomized trial of a multifaceted intervention in people with hypertension: The Heart Outcomes Prevention and Evaluation 4 (HOPE-4) Study. Am Heart J. 2018;203:57–66. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:1–8. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al. Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension. 2003;42(6):1206–52. Yang F, Katumba KR, Roudijk B, Yang Z, Revill P, Griffin S et al. Developing the EQ-5D-5L value set for Uganda using the ‘lite’protocol. PharmacoEconomics. 2022:1–13. Serrat-Costa M, Serra-Martínez Y, Cabrero-García J, Bertrán-Noguer C, Delclos GL, Coll-de-Tuero G, et al. A new validated international questionnaire on health professionals’ knowledge of hypertension diagnosis. Hipertensión y Riesgo Vascular. 2022;39(1):24–33. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345. Redfern J, Adedoyin RA, Ofori S, Anchala R, Ajay VS, De Andrade L, et al. Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment. BMJ global health. 2016;1(2):e000086. Reiss-Brennan B, Brunisholz KD, Dredge C, Briot P, Grazier K, Wilcox A, et al. Association of integrated team-based care with health care quality, utilization, and cost. JAMA. 2016;316(8):826–34. Porter ME. A strategy for health care reform—toward a value-based system. N Engl J Med. 2009;361(2):109–12. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4558011","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":316652692,"identity":"7ce51e6a-d44c-43e8-976e-22a9ee1cf0f4","order_by":0,"name":"Duah Dwomoh","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA30lEQVRIiWNgGAWjYDCCAwxsDDwghgTzARDF2MAAFCFSC1sCyVp4DIjTwncj+dmDt2020fzSPd8kvzDYyG44wH7tAT4tkjfSzA3ntqXlzpxzdpu0DEOa8YYDPOUG+LQY3Egwk+bddjh3w43cbdISDIcTgVrSJPBrSf8G1ZLzDKjlPzFacmC25LBJfmA4ANTCfgyvFskzb8ok5/4D+mVGmrE1g0Gy8czDPGx4tfAdT98m8eaMTW6/RPLDmz8q7GT7jrc/w6sFBTCDowZCEgkYf4Ap9gfEaxkFo2AUjIKRAABIRFB1CwmpAwAAAABJRU5ErkJggg==","orcid":"","institution":"University of Ghana","correspondingAuthor":true,"prefix":"","firstName":"Duah","middleName":"","lastName":"Dwomoh","suffix":""},{"id":316652693,"identity":"70b71499-a703-4a3a-8587-c2bdca4b9f6d","order_by":1,"name":"Gifty Sunkwa-Mills","email":"","orcid":"","institution":"PharmAccess Ghana","correspondingAuthor":false,"prefix":"","firstName":"Gifty","middleName":"","lastName":"Sunkwa-Mills","suffix":""},{"id":316652694,"identity":"5ec9aff1-c6e8-4312-a3e0-7402a73d0206","order_by":2,"name":"Kwasi Antwi","email":"","orcid":"","institution":"PharmAccess Ghana","correspondingAuthor":false,"prefix":"","firstName":"Kwasi","middleName":"","lastName":"Antwi","suffix":""},{"id":316652695,"identity":"ba354bfe-79d2-417c-9bcc-f1db776ceeca","order_by":3,"name":"Maxwell Antwi","email":"","orcid":"","institution":"PharmAccess Ghana","correspondingAuthor":false,"prefix":"","firstName":"Maxwell","middleName":"","lastName":"Antwi","suffix":""},{"id":316652696,"identity":"8cd46856-bbe0-45f1-b800-2d0f3326f06a","order_by":4,"name":"Tobias F. Rinke de Wit","email":"","orcid":"","institution":"University of Amsterdam","correspondingAuthor":false,"prefix":"","firstName":"Tobias","middleName":"F. Rinke","lastName":"de Wit","suffix":""}],"badges":[],"createdAt":"2024-06-10 12:25:35","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4558011/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4558011/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":59964439,"identity":"18a6811f-20b1-4540-a6b7-ca6dc854c3bc","added_by":"auto","created_at":"2024-07-10 01:51:32","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":74934,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFramework underlying proposed hypothesis\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003eNote: This framework was produced by the authors.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-4558011/v1/38967f488988e0865ab32dd7.png"},{"id":62590614,"identity":"5dc39174-6895-451a-b12f-d4fe61cce467","added_by":"auto","created_at":"2024-08-16 07:59:05","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":694269,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4558011/v1/a462bb22-71d1-4faf-b3db-d8de0a4c1966.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Impact of Value-Based Care on Quality of Life, Clinical Outcomes, Patient Satisfaction, and Enhanced Financial Protection among Hypertensive Patients inGhana: A Protocol for a Mixed Method Evaluation, 2024","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThere has been a significant increase in the burden of non-communicable diseases (NCDs) in sub-Saharan Africa (SSA) over the past two decades, driven by demographic, socio-economic, and environmental factors such as unhealthy diets, reduced physical activity, hypertension, obesity, diabetes, dyslipidemia, and air pollution(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Hypertension is a major public health concern that contributes substantially to the rising global trend in morbidity and premature mortality (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). It remains the leading cause of cardiovascular disease globally, and CVD remains the leading cause of death worldwide (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). It is estimated that at least two-thirds of cardiovascular deaths now occur in low- and middle-income countries (LMICs), bringing a double burden of disease to poor and developing world economies (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Ferdinand et al.,(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) showed that the highest levels of blood pressure worldwide have shifted from high-income countries (HIC) to LMICs, and the World Health Organization (WHO) estimates that the prevalence of hypertension is highest in the African region, with about 46% of adults aged 25 years and older being hypertensive compared to 35% in the Americas and other HIC, and 40% elsewhere in the world (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). An estimated 1.28\u0026nbsp;billion adults aged 30\u0026ndash;79 years worldwide have hypertension, most (two-thirds) living in LMIC, and less than half of adults (42%) with hypertension are diagnosed and treated. It is estimated that approximately 1 in 5 adults (21%) with hypertension have this condition under control. Uncontrolled hypertension may increase the risk of stroke, myocardial infarction, cardiac failure, and renal failure, among others (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), and it accounts for approximately 9.4\u0026nbsp;million deaths annually(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). It has been suggested that the prevalence of hypertension is increasing rapidly in SSA, and the estimated number of adults with hypertension in 2025 is predicted to increase to a total of 1.56\u0026nbsp;billion, with a disproportionate prevalence in developing countries, including sub-Saharan Africa, compared to high-income countries(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe prevalence of hypertension in Ghana from the medical literature varies. Some reported prevalence of hypertension ranges from 26\u0026ndash;35%, with a higher prevalence recorded among men(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Others reported a higher prevalence of 59% (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e), and it is estimated that two-thirds of the hypertensives were unaware of their condition, and approximately 50% of those with a history of hypertension on medication were controlled(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Additional studies report a very low prevalence of controlled hypertension among those who are on treatment in Ghana (approximately 3\u0026ndash;12%)(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Risk factors of hypertension in Ghana include but are not limited to age, marital status, gender, and residence (urban, rural), consumption of table salt, salted meat, alcohol, canned meats, smoking, and psychological factors, including stress and anxiety, higher education and socio-economic status, employment, access to medical insurance, overweight(\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Other factors include poor adherence to medication, inadequate health system capacity for early diagnosis due to an increasing number of patients, inequitable distribution of healthcare facilities affecting access, financial sustainability of the National Health Insurance Scheme, and delays in reimbursement of claims to facilities that affect the health system\u0026rsquo;s ability to provide timely management of hypertension(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Healthcare facilities and practitioners\u0026rsquo; use of non-standardized and uncalibrated blood pressure measuring equipment are among the challenges reported in the medical literature(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). Low providers\u0026rsquo; knowledge of hypertension and patients\u0026rsquo; awareness, policy-level challenges precluded nurses from prescribing or dispensing antihypertensives and licensed chemical sellers from stocking same(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eDespite the benefits of hypertension management in reducing cardiovascular morbidity and mortality, evidence from the medical literature shows that the burden of hypertension remains high and control rates are poor in LMIC (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) and the SDG goal of reducing cardiovascular disease mortality by 30% by 2030 may not be met (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). There is evidence that most individuals are not adequately treated, and there is no value for money(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). In particular, Health Insurance Schemes for healthcare today are based on rewarding volume, not value for the money spent(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e) and VBC stipulates a healthcare reform and policy change that must focus on improving health and healthcare value for patients(\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eVBC is a healthcare delivery model that emphasizes improving patient outcomes while optimizing costs. It shifts the focus from the volume of services provided to the value delivered to patients. This value-driven form of reimbursement has emerged as an alternative to the traditional fee-for-service reimbursement, which pays providers based on the quantity of services delivered. In the standard care system, providers deliver care services in a fragmented manner. In a value-driven care system, experience and outcome measures drive care delivery. The costs of care are not calculated per care service but per outcome achieved. The VBC model revolves around health outcomes generated in the patients, which can be determined based on specific measures, such as the reduced need for hospital readmission, improvement in health-related quality of life, better patient satisfaction, and enhanced financial protection. These measurements are used to adapt and combine care services along a patient journey (in the form of bundles) to maximize the outcomes while minimizing the costs.\u003c/p\u003e \u003cp\u003eThis study aims to implement and evaluate the impact of comprehensive value-based care (VBC) intervention on health-related quality of life, patients\u0026rsquo; clinical outcomes, patient satisfaction, and financial protection among NHIA-insured hypertensive patients. In addition, the study will assess challenges associated with VBC intervention in providing quality and cost-effective hypertensive care at health facilities and the mitigation strategies needed to address these challenges.\u003c/p\u003e \u003cp\u003e \u003cb\u003eStudy hypothesis.\u003c/b\u003e \u003c/p\u003e \u003cp\u003eWe hypothesized that a VBC approach to improving clinical outcomes (lowering blood pressure, improving blood sugar, body mass index, and waist circumference, improved health-related quality of life, reducing cost of care, increasing level of adherence to treatment, and reducing other risk factors), informed by detailed analysis of health system and patient-specific barriers, would be superior to standard care in individuals with poorly controlled or newly diagnosed hypertension. That is, we determined whether a VBC model that involves key stakeholders\u0026rsquo; participation (patients, healthcare workers, NHIA, PharmAccess, and CHAG) via the provision of effective medications and a comprehensive treatment and management plan could substantially improve clinical outcomes and overall quality of life and simultaneously reduce the cost of treatment of hypertension and its complications.\u003c/p\u003e \u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003eIntervention components\u003c/h2\u003e \u003cp\u003eIn a VBC model, healthcare providers are incentivized to deliver high-quality, cost-effective care and are held accountable for the outcomes achieved. The benefits of a value-based healthcare system extend to patients, providers, payers, suppliers, and society, and VBC has the promise to significantly increase the overall health gains of the population. To chart a different trajectory and build human-centered health systems that generate better long-term value for society, the National Health NHIA, in collaboration with PharmAccess and CHAG, will implement and evaluate a VBC intervention for hypertensive patients. This VBC intervention will include different aspects of VBC as outlined in the strategic framework for value-based care implementations(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). This includes interventions that focus on understanding patient needs, patient-centered solutions such as behavioral and self-management interventions and integrating monitoring and learning systems for providers. Its aim is to align the interests of all stakeholders in the health system, including patients, providers, payers, and policymakers. VBC aligns these stakeholders with a common goal: achieving outcomes that matter to patients at the optimal cost.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eContent of the intervention\u003c/h2\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eTraining healthcare workers to improve their knowledge, attitude, and practices towards hypertensive care.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eProvision of critical medical equipment and essential medicine lists to promote the quality of hypertensive care.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePromote clinician-led patient follow-up.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eProvide training for hypertensive patients on strategies to improve adherence to hypertensive medication and clinical outcomes.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eProvide incentives to healthcare workers to deliver high-quality and cost-effective care.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eUtilize digital technology to improve behavioral counseling programs for hypertensive patients.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eProvide training for patients and caregivers on self-hypertensive management.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eForm patient groups where they discuss and share knowledge on hypertensive management.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eUtilize a digital behavioral counseling program.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eDevelop a value-based payment model.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eImplement an information technology program to track patients' progress.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eConceptual framework\u003c/h2\u003e \u003cp\u003eFigure 1 shows the framework for testing this hypothesis. This framework, developed by the authors, is based on subject knowledge of the VBC model and a literature review of factors associated with uncontrolled hypertension. The VBC interventions (such as the behavior change program, training of health professionals, providing incentives, etc.) are expected to better meet patient needs, improving patient care experience and health behaviors. These factors will contribute to better quality of life and clinical outcomes, preventing complications and reducing the overall costs for hypertensive patients in the VBC arm of this study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eExpected Outcome\u003c/h2\u003e \u003cp\u003eThe study will generate evidence regarding the effectiveness of VBC intervention on hypertension management in Ghana.\u003c/p\u003e \u003c/div\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eEvaluation design\u003c/h2\u003e \u003cp\u003eThe study will utilize a mixed-method evaluation design that incorporates both quasi-experimental design and qualitative design techniques to evaluate the impact of VBC on patients' clinical outcomes, health-related quality of life, and financial protection among NHIA-insured hypertensive patients visiting CHAG facilities in Ghana. This study's design is ideal compared to cluster-randomized control trials (RCT), even though RCT is more robust with minimal bias and high internal validity. However, we consider the randomization of facilities to receive VBC interventions untenable since facilities were pre-selected based on resource availability and the willingness of the facility in charge to implement VBC.\u003c/p\u003e \u003cp\u003eTo improve the internal validity of the quasi-experimental design, control facilities that share similar characteristics with the intervention facilities will be carefully selected such that there will be no systematic difference between the intervention and control facilities, and changes in health outcomes could be attributed to the VBC. Each selected intervention facility will have a control facility in the same region and at the same administrative level of the health facility (hospital, health center, etc.) to minimize bias associated with the location and the level of health facility. In addition, the same inclusion criteria for hypertensive patients would apply in the intervention and control health facilities to minimize within-patient bias.\u003c/p\u003e \u003cp\u003eThe VBC intervention will be implemented at the facility level, targeting healthcare providers and patients who are nested within health facilities and will be followed over time.\u003c/p\u003e \u003cp\u003eA baseline survey will be conducted in all the intervention and control facilities to assess the mean and prevalence of the outcome measures and their risk factors among hypertensive patients visiting these facilities on specialized clinic days. Hypertensive patients in the controlled health facilities will receive standard care as provided during the regular clinic days. To improve the control of hypertension and save costs, the intervention facilities will receive VBC intervention programs delivered by trained intervention managers. The intervention will be given for 24 months (2 years), but a midline survey will be conducted in 12 months and at 24 months post-baseline).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStudy settings\u003c/h2\u003e \u003cp\u003eThe study will be conducted in 32 Christian Health Association of Ghana (CHAG) accredited health facilities (hospitals and health centers) in five administrative regions of Ghana that provide services for hypertensive patients. Twenty health facilities will constitute the intervention facilities, and the remaining 12 facilities with similar characteristics to the intervention facilities will be selected within the same region as comparison health facilities to reduce the effect of selection bias that arises from quasi-experimental studies.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eTarget population\u003c/h2\u003e \u003cp\u003eThis study will involve hypertensive patients who visit CHAG facilities in Ghana's six administrative regions. It will also involve healthcare workers (hospital administrators, medical doctors, nurses, pharmacists, and laboratory technicians) and VBC implementers at PharmAccess, CHAG, and the National Health Insurance Authority (NHIA).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003ePower analysis and sampling design\u003c/h2\u003e \u003cp\u003eWe assumed that if the value-based care is effective, both systolic and diastolic blood pressure will reduce by 5 mmHg on average among patients in the intervention facilities compared to patients in the control facilities. We further assumed a power of 90% to detect a significant effect of the value-based care if it exists, type I error of 5%, attrition rate of 10%, standard deviation of 10 mmHg(\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e), average cluster size of 20 representing the average number of hypertensive patients seen on a clinic day per visit with a coefficient of variation of cluster sizes 0.5 and a design effect of 4.6 to adjust for correlation of the outcome measure at the facility level assuming an intra cluster correlation (ICC) of 0.15. We also assumed that the correlation between baseline measurements (or other predictive covariates) and hypertension is 0.5. The estimated number of health facilities will be 32 (16 control facilities and 16 intervention facilities). Ideally, 16 control health facilities should have been selected to increase the power of the study. Today, the intervention has already been started with stakeholder engagement and training, albeit at a slow pace and intensity in 20 health facilities. This implies that of the 32 facilities, the remaining 12 can serve as a comparison group, which corresponds to 712 hypertensive patients (450 patients in the intervention facilities and 262 patients in the control facilities). On average, about 20 hypertensive patients receiving care on clinic days who meet the inclusion criteria and consent to be part of the study will be interviewed per facility.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eEthical Considerations\u003c/h2\u003e \u003cp\u003e The study has secured ethical approval from the Christian Health Association of Ghana (CHAG) Ethics Review Committee, with ethics approval number CHAG-IRB01012024. CHAG is the legally mandated institution required to provide ethical approval for all health-related research in CHAG-accredited health facilities. We emphasize that study participants will not be named in any report, and we will keep their identities confidential. Electronic data will be safeguarded in a password-protected folder, and only authorized users on the study team will be able to access it.\u003c/p\u003e \u003cp\u003e \u003cb\u003eStudy participant's inclusion criteria.\u003c/b\u003e \u003c/p\u003e \u003cp\u003eEligible health facilities will be CHAG-accredited health facilities providing hypertensive services for patients on clinic days. Eligible participants will comprise all consenting patients (male and female), age 18 years and above, visiting CHAG facilities on a clinic day because of past or current diagnosis of hypertension. That is, all patients visiting hypertensive clinics with the following:\u003c/p\u003e \u003cp\u003e1) Systolic blood pressure (SBP)\u0026thinsp;\u0026ge;\u0026thinsp;160 mm Hg is recorded at the first onsite screening.\u003c/p\u003e \u003cp\u003e2) SBP 140\u0026ndash;159 mm Hg is recorded at first onsite screening, AND the participant reported a medical diagnosis of hypertension or is taking anti-hypertension medication.\u003c/p\u003e \u003cp\u003e3) SBP less than 140mm Hg is recorded at first onsite screening, AND the participant reported a medical diagnosis of hypertension or is taking anti-hypertension medication at the health facility.\u003c/p\u003e \u003cp\u003e4) Participants did not meet criteria 1\u0026ndash;3, but SBP 140\u0026ndash;159 mm Hg was recorded on two separate screenings at the facility within 1 hour.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eExclusion criteria\u003c/h2\u003e \u003cp\u003eParticipants will be excluded if they meet these criteria but are unable to participate in the study due to sickness or any other form of serious illness that makes it impossible for him/her to grant an interview, refuse to consent, concurrently participate in any other intervention-based study that would compromise the protocol of VBC, had a severe comorbid condition with life expectancy\u0026thinsp;\u0026lt;\u0026thinsp;1 year, or factors likely to interfere with study participation or with their ability to complete the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eDropout\u003c/h2\u003e \u003cp\u003eParticipants will be considered dropouts if they are unwilling to continue their participation for any reason, withdraw due to health problems, or if someone dies within the study period. To minimize the rate of loss to follow-up during our subsequent interviews, we will select hypertensive patients who are likely to visit the same health facility for hypertensive care for the next 12 months. There will be regular follow-up reminders and incentives for continued participation.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eCollection of qualitative information\u003c/h2\u003e \u003cp\u003eA nested qualitative study will be conducted within the quasi-experimental design. Semi-structured in-depth interviews of key informants will be conducted to capture the perspectives and experiences of the value-based care intervention and perceived barriers and enablers faced during the implementation of the intervention, the impact of the VBC on the quality of life of hypertensive patients, etc. We will develop an interview guide based on the study objectives and previous literature to align with the research goals.\u003c/p\u003e \u003cp\u003eUsing a purposive sampling approach, data will be collected from all targeted populations, including patients, service providers (clinicians, nurses, pharmacists, laboratory technicians), PharmAccess, CHAG, NHIA, and all other relevant stakeholders. A total of 30 in-depth interviews with key informants will be conducted (15 interviews in the intervention facilities and 15 interviews in control facilities). The qualitative interviews will be truncated when we reach thematic saturation.\u003c/p\u003e \u003cp\u003eIn addition, a total of three key informants will be interviewed from NHIA, CHAG, and PharmAccess. All interviews will be digitally recorded and transcribed verbatim after translating from the local language to English. Transcripts will be reviewed through a quality assurance system for accuracy and consistency. Transcripts that are found to meet the quality standards after a thorough review will be analyzed using a thematic content analysis approach. A sample of each set of transcripts from the different targeted populations will be reviewed by the consultants. Themes based on the interview guide underpinned by the objectives will be developed with consultants coming to a consensus on where differences exist in themes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eQualitative analysis\u003c/h2\u003e \u003cp\u003eResearchers will independently code the transcripts by assigning codes to segments of text that capture key concepts and ideas. Codes will be refined and grouped into broader themes that represent the core findings of the interviews. Data will be analyzed through the framework approach (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e), which embraces inductive (emerging codes) and deductive (a priori code from the utilization-focused evaluation module) methods. The framework approach involves six (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) iterative steps: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) familiarization with the data, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) generating initial codes or assignment of primary codes to the dataset to describe the content, (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) searching for patterns and codes across the different interviews, (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) codes revision, (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) codes definition and (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) producing the report through the interpretation of results. The inductive method will involve steps 1 and 2, while the deductive method will involve steps 3 to 6. The codes will be discussed and compiled into a codebook to guide the coding and categorization of the data. The deductive analysis approach will ensure coding data units according to evidence relating to impact, challenges, and mitigation strategies associated with implementing VBC at the health facilities. The coding process will be done in QRS NVivo version 12 to enhance the rigor and audit trail of all data coded.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eTraining of enumerators and supervisors\u003c/h2\u003e \u003cp\u003eThe training will focus on understanding the content of the data collection instrument, key objectives of the VBC project, data collection methods, ethical consideration in scientific research, code of conduct during field surveys, informed consent, communication channel, ensuring data quality, collection of GPS coordinates of the health facilities and the households, conducting interviews, checking completed questionnaires, digital data entry, and ensuring standard operating procedures are followed. Specifically, the training will involve an overview of the activity and evaluation methodology, informed consent and confidentiality, data quality assurance procedures and quality checklists, mock practices with each tool, qualitative data collection practices (facilitation, inclusiveness, probing), piloting the tool, securing data storage and transfer, common troubleshooting and daily reporting and oversight. Training will incorporate a complete review of the survey instruments and role-play to simulate real-life interview scenarios. Supervisors will also receive special leadership training skills during this period to efficiently coordinate the fieldwork activities and ensure adherence to the project timelines.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eData Integration\u003c/h2\u003e \u003cp\u003eQuantitative and qualitative findings will be triangulated to better understand the impact of VBC intervention, challenges, and mitigation strategies associated with the implementation of the VBC intervention at the health facilities. Qualitative data will enrich the quantitative findings by providing an in-depth understanding of hypertensive patients and other stakeholders' lived experiences regarding the VBC intervention. With the analysis and integration of data from two sources obtained by the mixed methods approach, the findings can be corroborated, and the weakness or bias of any of the methods or data sources can be compensated for by the strengths of another, thereby increasing the validity and reliability of the results.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003ePrimary outcome measures\u003c/h2\u003e \u003cp\u003eThe primary outcome measures include systolic blood pressure and diastolic blood pressure. Participants will be considered to have high blood pressure if recorded SBP\u0026thinsp;\u0026ge;\u0026thinsp;130 mmHg and/or DBP\u0026thinsp;\u0026ge;\u0026thinsp;80 mmHg(\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e)). These primary outcomes will be compared between intervention and control groups after 12 and 24 months of implementing the value-based care intervention. We will also compare the difference in mean systolic and diastolic blood pressure levels at baseline, midline, and post-intervention periods for the control and intervention groups. Blood pressure will be measured using a calibrated Omron Premium Blood Pressure Monitor Device, Omron HEM-7322 (Australia). Blood pressure will be measured from the right arm with the person sitting upright after 3 min of rest, and a further measurement will be taken following a period of at least 3 minutes of rest. If a major difference is observed between the first two measures, a third measure will be taken, and the nearest two measures will be recorded. The two readings will be averaged separately for SBP and diastolic blood pressure (DBP).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eSecondary outcome measures\u003c/h2\u003e \u003cp\u003eThe secondary outcome measures include blood sugar level, health-related quality of life, weight and height, waist, hip circumference and waist-to-hip ratio (WHR), adherence to medication, health professional knowledge, depression anxiety, stress, and the average cost of care.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eBlood sugar\u003c/h2\u003e \u003cp\u003eThe blood sugar level will be monitored using the HbA1c test. A normal HbA1c level is below 5.7%, 5.7\u0026ndash;6.4% indicates prediabetes and 6.5% or more indicates diabetes. Within the 5.7\u0026ndash;6.4% prediabetes range, the higher your HbA1c, the greater your risk of developing type 2 diabetes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eHealth-related quality of life\u003c/h2\u003e \u003cp\u003eThe EQ-5D will be used to assess the health-related quality of life of the study participants(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). It consists of five sets of questions measuring five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question is rated on a 5-point scale (1 \u0026ndash; No problem to 5 - Unable/extreme problems). Using a value set, the individual health rating is converted to a health-rated quality of life index ranging from 0 (dead) to 1(fully healthy). The value set is a set of weights applied to each severity level in the 5 dimensions. Higher weight is applied to high severity while low weight is applied to low severity on quality of life.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eWeight and height\u003c/h2\u003e \u003cp\u003eThis study will use the portable stadiometer (SECA, United Kingdom) with an accuracy of 1 mm to measure the heights of the participants, i.e., from the heel to the highest point of the head, will be measured. The study participants will be asked to take off their shoes during the measurement. The weight of the participants will be measured using a calibrated weighing scale to the nearest 0.1 kg. Then, the Body Mass Index (BMI) for each participant will be calculated as follows: \u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(weight/{height}^{2}\\)\u003c/span\u003e\u003c/span\u003e.\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eWaist, hip circumference, and WHR\u003c/h2\u003e \u003cp\u003eThe waist circumference of each participant will be measured using a flexible tape to the nearest 0.1 mm. The point of measurement, i.e., above the hip bone, will be fixed for all respondents, and the respondents will be advised to relax the stomach by breathing out gently and not to suck in the tummy. The tape will be placed properly and parallel to the floor without compressing the skin. The measurement will be taken around the waistline at the end of normal expiration. The area with maximum protrusion of the buttocks on standing with the feet close together will be considered as the reference point for the hip circumference measurement. We will estimate the waist-to-hip ratio (WHR) from the values obtained from the two indicators.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003eAdherence to hypertensive medication\u003c/h2\u003e \u003cp\u003eThe Hill-Bone High Blood Pressure Compliance Scale will be used to assess the level of compliance across three behavioral domains critical for HBP care and control: 1) reducing sodium intake, 2) appointment keeping, and 3) medication taking. The scale has 14 items rated on a four-point scale from 1 \u0026ndash; Never to 4 - All the time. The total score is computed by summing the response ratings, and the score ranges from 14 to 46. A high score is indicative of noncompliance, and a low score is indicative of compliance.\u003c/p\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eHealth professional knowledge\u003c/h2\u003e \u003cp\u003eA newly validated international questionnaire will be used to assess health professionals\u0026rsquo; knowledge of hypertension diagnosis (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e)The tool enables objective and comprehensive assessment of medical and nursing professionals' knowledge of the initial diagnosis of hypertension.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section3\"\u003e \u003ch2\u003eDepression, Anxiety, and Stress\u003c/h2\u003e \u003cp\u003eDepression, Anxiety, and Stress Scale (DASS-21) will be used to assess depression, anxiety, and stress among hypertensive patients. The DASS-21 is a self-report measure in which hypertensive patients will rate the frequency and severity of experiencing negative emotions over the previous week. Frequency/severity ratings are made on a series of 4-point scales (0 = did not apply to me at all, 3 = applied to me very much, or most of the time).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e \u003ch2\u003eCost of treatment\u003c/h2\u003e \u003cp\u003eThis study will use structured questionnaires to measure out-of-pocket health expenditures (direct and indirect cost) before and after VBC intervention among patients in the intervention and control health facilities.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec28\" class=\"Section2\"\u003e \u003ch2\u003eCost of implementing VBC intervention\u003c/h2\u003e \u003cp\u003eIntervention costs for VBC in this study refer to the resources used to operate and deliver the intervention. The intervention cost of the VBC hypertension management program will include the cost of training for medical practitioners to deliver lifestyle coaching sessions, the cost of the venue for training, the cost of delivering lifestyle coaching sessions, the cost of medication, the cost of communication for providers to reach out to patients to improve adherence, cost of periodic reviews of outcomes and costs leading to continuous improvement cost of implementing and testing digital behavioral counseling program, patient tracking, and cost of training patients on self-management. Overall, the ingredients approach will be used to collect all relevant cost data. This approach means that all relevant materials and items required for implementing each activity will be quantified and valued. For example, training of healthcare providers, patients, etc. Personnel costs, including per diem for trainees, honorarium for trainers, venue, stationery, and other relevant logistics, will be costed to measure financial cost. Where relevant capital items will be costed and annualized at a 3% discount rate. Financial costs will be estimated by calculating direct medical (e.g., drugs, laboratory tests) and non-medical costs (e.g., transportation, personnel costs, etc). Indirect cost will also be measured for productivity losses to appreciate the opportunity cost of the intervention. This will include travel time, time spent in training, etc. The total economic cost is the sum of the direct and indirect costs. The study will use the health care provider perspective, payer (NHIS) perspective and societal perspective. If proven effective, the consequences of implementing this intervention include increased quality of life from patients achieving blood pressure control and savings in resources by avoiding hospitalizations that could have otherwise occurred. The following steps will be taken to micro-cost the VBC intervention.\u003c/p\u003e \u003cp\u003eStep 1: This will involve defining the VBC processes and identifying the types of resources that are used in carrying out those processes. This step could include reviewing documents or literature, conducting a site visit, or talking to core staff. The purpose is to gain a detailed understanding of how the VBC operates and to identify an inventory list of what resources are involved and how they are used.\u003c/p\u003e \u003cp\u003eStep 2: We will systematically measure the unit quantity of each type of resource consumed. That is, we will determine the quantity used for each type of resource identified in step 1.\u003c/p\u003e \u003cp\u003eStep 3: Each type of resource will be assigned a unit cost, and for each resource type, the unit cost will be multiplied by the unit quantity and aggregated to find the total cost.\u003c/p\u003e \u003cp\u003eStep 4: Finally, adjustments will be made to any assumptions, such as the value of a certain resource or assumptions that might influence the estimated quantity of resources consumed as part of the implementation of the VBC intervention, to test the robustness of the estimates and show how it might change under different sets of assumptions.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec29\" class=\"Section2\"\u003e \u003ch2\u003eSelection of comparison facilities\u003c/h2\u003e \u003cp\u003eComparison health facilities were carefully selected to reflect the characteristics of the intervention facilities. For each intervention facility, a control facility will be selected from the same region and the same level of care as there are marked differences in the availability of qualified medical personnel, logistics (medicines and supply), and poverty across the regions. Patients in the controlled facilities will only receive the usual standard hypertensive care, and they will not receive the VBC-based intervention. Standard hypertensive care in this study refers to the usual care they receive when they visit hypertensive clinics.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePotential confounders\u003c/h3\u003e\n\u003cp\u003eThe independent variables of interest in this study include the respondent's sex, age in years, current marital status, educational level, religion, employment status, religious affiliation, valid NHIS card, study location, household size, lifestyle factors (exercise, anxiety, depression, stress and diet, alcohol and smoking), and household wealth.\u003c/p\u003e \u003cdiv id=\"Sec31\" class=\"Section2\"\u003e \u003ch2\u003eData management\u003c/h2\u003e \u003cp\u003eEach participant will be assigned a unique identification number after the baseline survey. This will facilitate and reduce the errors in linking lab-based clinical outcomes to other patients' records. The research team members will develop the study tool for the baseline, midline, and endline surveys. Data collection would be done electronically during face-to-face interviews at the facility or respondent homes using Open Data Kit. Prior to the commencement of fieldwork, there will be recruitment for the positions of laboratory scientist for each health facility, field data collectors (enumerators), and supervisors. The laboratory scientist will lead the collection of all blood samples for testing. A one-week training would be organized for enumerators and field supervisors focusing more on the questionnaire's definitions of key outcome variables of interest and how to ensure data quality. The training of enumerators and supervisors will be preceded by training on the ethics of research involving human subjects. Training will incorporate a complete review of the survey instruments and role-play to simulate real-life interview scenarios. Supervisors will also receive special leadership training skills in order to efficiently coordinate the activities of the fieldwork and to ensure adherence to the timelines of the project. All interviews would be completed by small teams of enumerators led by a field supervisor. The supervisors would be responsible for monitoring the field enumerators. The enumerators, team leaders, and field supervisors would be selected based on their experience conducting longitudinal cluster randomized studies and fluency in the relevant local languages. To reduce the unit non-response rate, each enumerator would approach a household up to three times to locate respondents. In addition, the telephone number of the respondent and close relative will be obtained after informed consent to follow up with patients throughout the study. The training manual will be used throughout the training period and as a reference throughout the survey. Two days will be allocated for the pre-test of questionnaires and discussions with supervisors and enumerators to ensure familiarity and address outstanding issues arising from the pre-test at Ghana Health Service (GHS)try facilities. The study investigators will be responsible for data quality control issues handled on three different levels. The first level is the real-time logic and range checking built into the online data entry system. The second level of quality control involves the study investigators conducting real-time daily checks. Checks will identify complicated and less common errors. The third level of quality control involves local monitoring, where data in our database will be checked, and if errors are identified, research assistants who commit these errors will be identified using the system and asked to correct them before moving to the next stage of data collection.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec32\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eAnalysis and reporting of the effect of the VBC will follow the Consolidated Standards of Reporting Trials guidelines for cluster randomized controlled trials (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). The study will utilize descriptive and inferential statistics to address the study objectives. Mean, standard deviations, minimum and maximum observations, and confidence intervals will be reported for normally distributed continuous outcome measures. The median and interquartile range will be reported for non-normally continuous variables. Both graphical (histogram superimposed with a normal distribution curve) and numerical methods (Shapiro Francia and skewness and kurtosis test) will be used to determine whether continuous variables approximate normality. Categorical variables will be summarized using frequencies and percentages of each category, and the association between categorical variables will be analyzed using the chi-squared test of independence (with Yates correction for 2 \u0026times; 2 tables) or Fisher\u0026rsquo;s exact test in cases where expected frequencies are low. The study will employ both parametric and non-parametric inferential statistical methods. The student\u0026rsquo;s t-test (for parametric variables) or the Wilcoxon Rank sum test (for non-parametric variables) will be used to test the hypothesis of difference in means or medians of continuous outcomes between intervention and control groups. Z-test for comparing the differences in proportion will be used to test the hypothesis of the difference in the proportion of binary outcome measures between intervention and control. To quantify the impact of the VBC intervention on the outcome measures of interest, intention-to-treat-based difference-in-difference analysis with a multivariable ordinary least square regression, quantile regression, binary logistic regression model, Negative binomial and Poisson regression models with robust standard errors will be used depending on the measurement scale of the outcome measure. The analysis of both primary and secondary outcome measures will account for the clustering effect and use a mixed effects model considering the facility as a random intercept effect. Additionally, individual-level marginal modeling (population-averaged model) using generalized estimating equations (GEEs) with an exchangeable correlation structure will be used. The consistency of VBC's impact on the primary outcome will be explored in predefined subgroups, including sex, age categories, education, region, marital status, and comorbidities. We will test whether the effects varied by subgroups using tests of interaction-based models between subgroup variables and the treatment group. All statistical analyses will be conducted using Stata MP version 17 (StataCorp. 2021. Stata Statistical Software: Release 17. College Station, TX: StataCorp LLC), and a two-sided test at the 0\u0026middot;05 level will be considered to be statistically significant. Final results will be expressed as mean/proportion (95% CI) in each group, and two-sided p values will be reported.\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe Ghanaian National Health Insurance Scheme (NHIS) rewards the volume of services provided to hypertensive patients, not the value for the money spent. We developed a research protocol to assess the cost-effectiveness of value-based care intervention for hypertensive patients. This protocol will generate evidence to shape public opinion regarding the effectiveness of value-based care on hypertension management and the possibility of policy formulation to scale up to other health facilities and eventually incorporate it into health insurance.\u003c/p\u003e \u003cp\u003eDespite the benefits of hypertension management and the availability of safe and low-cost medications in reducing cardiovascular morbidity and mortality, evidence from medical literature shows that the burden of hypertension remains high, and control rates are poor in developing countries. Controlled hypertension is one of the priority areas identified by the WHF for action if the target of a 25% reduction in premature CVD mortality by 2025 is to be achieved(\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThis study aims to implement and evaluate an innovative digital VBC intervention in Ghana. Our study will assess the effectiveness of VBC on health-related quality of life, clinical outcomes, and cost of treatment. The VBC approach to healthcare allows health professionals to think differently about their role within the larger care team and the services they provide in general. For instance, in the absence of value-based care, most physicians are largely concerned with what happens in the consulting room and, in most cases, do not follow up with patients outside office hours to enquire about progress made after the first appointment.\u003c/p\u003e \u003cp\u003eOur proposed VBC intervention starts with identifying and understanding hypertensive patients whose health and related circumstances create consistent needs relative to improved health outcomes and cost. To achieve this, the study plans to involve an interdisciplinary team of caregivers, policymakers, and patients to design and deliver comprehensive solutions to health-related challenges associated with providing quality care at an affordable cost. The research team will measure the health outcomes and costs of care for each hypertensive patient during baseline, midline, and endline data collection and use the information to drive ongoing improvements, identify challenges and mitigation strategies, and assess the impact of VBC on the selected outcome measures. VBC interventions have been shown elsewhere to improve the quality of care, lower rates for some measures of acute care utilization, and lower actual payments received by the delivery system(\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). Others have argued about the need to introduce regulations to end coverage and price discrimination based on health risks or existing health problems and measure and report their subscribers\u0026rsquo; health outcomes, starting with a group of important medical conditions(\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). However, we need to provide evidence of the effectiveness of VBC interventions in improving the quality of care and reducing the cost of treatment to justify the need to shift focus to value-based healthcare. The health system is confronted with issues regarding the quality and cost of care, and the current payment system that encourages volume-driven care rather than value-driven care is a contributing factor(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). Healthcare providers and facilities gain increased profits by delivering more services to more people, resulting in increased healthcare costs without corresponding improvement in health outcomes. VBC could mitigate the impact of factors that drive healthcare cost of hypertensive treatments, such as the prevalence of hypertension in the population (for example, how many people have hypertension), the number of times patient receives care they require per condition (for example, how many hypertension-related comorbidities a person with hypertension has); the number and types of health care services the hypertensive patient receives in each episode (for example, when a person has uncontrolled hypertension, does he or she receive heart-related treatment induced by hypertension or simply medical management?); the number and types of processes, devices, and drugs involved in each hypertensive service and finally, the prices of each of those individual processes, devices, and drugs. To the best of our knowledge, no studies have been conducted in Ghana and, to a large extent, LMIC to quantify the impact of value-based care on health-related quality of life, improved patient clinical outcomes, patient satisfaction, and enhanced financial protection among NHIA-insured hypertensive patients. This evaluation study will (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) allow us to generate evidence on the impact of VBC on the aforementioned outcome measures, identify challenges and mitigation strategies associated with the implementation of VBC interventions, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) help to sensitize the policymakers on the need to shift from volume-driven care to value-driven care, and finally (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) allow a debate among health providers, policymaker, Civil Society Organizations and all other relevant stakeholders on the need to expand VBC to other facilities assuming the intervention prove to be cost-effective.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCHAG\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eChristian Health Association of Ghana\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eGHS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eGhana Health Service\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNHIA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Health Insurance Authority\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNHIS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNational Health Insurance Scheme\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eVBC\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eValue-Based Care\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study has secured ethical approval from the Christian Health Association of Ghana (CHAG) Ethics Review Committee, with ethics approval number CHAG-IRB01012024. CHAG is the legally mandated institution required to provide ethical approval for all health-related research in CHAG-accredited health facilities. The study will be conducted in accordance with the ethics guidelines of the Declaration of Helsinki. Informed consent will be secured from each study participant. The participants\u0026apos; confidentiality will be assured by not including names or personal identifiers during data collection, analysis, and reporting and respecting the privacy of study participants during interviews. Participants\u0026apos; right to refuse participation, not answer any questions they don\u0026rsquo;t want to, or withdraw participation after enrolling will be fully respected.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData will be made available upon reasonable request if all the necessary documentations are duly completed, and the request must be submitted through the CHAG Ethical Review Committees ([email protected])\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research will be funded by PharmAccess Ghana; however, the views expressed do not necessarily reflect PharmAccess Ghana and its global partners.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDD, GS, KA, MA, and TFR conceptualized the study and reviewed the draft manuscript. DD designed the data collection instrument, submitted the protocol for ethical approval, and wrote the initial draft protocol for submission. GS, KA, MA, and TFR reviewed the entire protocol. \u0026nbsp;All authors read and approved the final protocol.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe acknowledge all D\u0026amp;D Statistical Consulting Services Limited field enumerators who have agreed to lead the field data collection in October 2024. We also acknowledge all hypertensive patients, officials from CHAG and NHIA, and healthcare workers willing to participate in this study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBigna JJ, Noubiap JJ. The rising burden of non-communicable diseases in sub-Saharan Africa. Lancet Global Health. 2019;7(10):e1295\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAkpa OM, Made F, Ojo A, Ovbiagele B, Adu D, Motala AA, et al. Regional patterns and association between obesity and hypertension in Africa: evidence from the H3Africa CHAIR study. Hypertension. 2020;75(5):1167\u0026ndash;78.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchwalm J-D, McCready T, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas P, et al. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2019;394(10205):1231\u0026ndash;42.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCappuccio FP, Miller MA. Cardiovascular disease and hypertension in sub-Saharan Africa: burden, risk and interventions. Intern Emerg Med. 2016;11:299\u0026ndash;305.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNolla Sol\u0026eacute; JM. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990\u0026ndash;2010: a systematic analysis for the Global Burden of Disease Study 2010. The Lancet, 2012, vol 380, num 9859, p 2224\u0026ndash;2260. 2012.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFerdinand KC. Uncontrolled hypertension in sub-Saharan Africa: now is the time to address a looming crisis. J Clin Hypertens. 2020;22(11):2111.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOrganization WH. A global brief on hypertension: silent killer, global public health crisis: World Health Day 2013. World Health Organization; 2013.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuwatudde D, Nankya-Mutyoba J, Kalyesubula R, Laurence C, Adebamowo C, Ajayi I, et al. The burden of hypertension in sub-Saharan Africa: a four-country cross sectional study. BMC Public Health. 2015;15:1\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBromfield S, Muntner P. High blood pressure: the leading global burden of disease risk factor and the need for worldwide prevention programs. Curr Hypertens Rep. 2013;15:134\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. lancet. 2005;365(9455):217\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAtibila F, Hoor Gt, Donkoh ET, Wahab AI, Kok G. Prevalence of hypertension in Ghanaian society: a systematic review, meta-analysis, and GRADE assessment. Syst reviews. 2021;10(1):220.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBosu WK, Bosu DK. Prevalence, awareness and control of hypertension in Ghana: A systematic review and meta-analysis. PLoS ONE. 2021;16(3):e0248137.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTannor EK, Nyarko OO, Adu-Boakye Y, Owusu Konadu S, Opoku G, Ankobea-Kokroe F, et al. Prevalence of hypertension in Ghana: Analysis of an awareness and screening campaign in 2019. Clin Med Insights: Cardiol. 2022;16:11795468221120092.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSanuade OA, Awuah RB, Kushitor M. Hypertension awareness, treatment and control in Ghana: a cross-sectional study. Ethn Health. 2020;25(5):702\u0026ndash;16.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDai B, Addai-Dansoh S, Nutakor JA, Osei-Kwakye J, Larnyo E, Oppong S, et al. The prevalence of hypertension and its associated risk factors among older adults in Ghana. Front Cardiovasc Med. 2022;9:990616.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKonlan KD, Lee H, Lee M, Kim Y, Lee H, Abdulai JA. Risk factors associated with the incidence and prevalence of hypertension in Ghana: an integrated review (2016\u0026ndash;2021). Int J Environ Health Res. 2023;33(11):1132\u0026ndash;47.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOpoku S, Addo-Yobo E, Trofimovitch D, Opoku RB, Lasong J, Gan Y et al. Increased prevalence of hypertension in Ghana: New 2017 American College of Cardiology/American Hypertension Association hypertension guidelines application. J global health. 2020;10(2).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKoduah A, Nonvignon J, Colson A, Kurdi A, Morton A, Van Der Meer R, et al. Health systems, population and patient challenges for achieving universal health coverage for hypertension in Ghana. Health Policy Plann. 2021;36(9):1451\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLaar AK, Adler AJ, Kotoh AM, Legido-Quigley H, Lange IL, Perel P, et al. Health system challenges to hypertension and related non-communicable diseases prevention and treatment: perspectives from Ghanaian stakeholders. BMC Health Serv Res. 2019;19:1\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCarter BL, Coffey CS, Ardery G, Uribe L, Ecklund D, James P, et al. Cluster-randomized trial of a physician/pharmacist collaborative model to improve blood pressure control. Circulation: Cardiovasc Qual Outcomes. 2015;8(3):235\u0026ndash;43.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJafar TH, Hatcher J, Poulter N, Islam M, Hashmi S, Qadri Z, et al. Community-based interventions to promote blood pressure control in a developing country: a cluster randomized trial. Ann Intern Med. 2009;151(9):593\u0026ndash;601.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBennett JE, Stevens GA, Mathers CD, Bonita R, Rehm J, Kruk ME, et al. NCD Countdown 2030: worldwide trends in non-communicable disease mortality and progress towards Sustainable Development Goal target 3.4. lancet. 2018;392(10152):1072\u0026ndash;88.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMiller HD. From volume to value: better ways to pay for health care. Health Aff. 2009;28(5):1418\u0026ndash;28.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePorter ME, Teisberg EO. How physicians can change the future of health care. JAMA. 2007;297(10):1103\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTeisberg E, Wallace S, O\u0026rsquo;Hara S. Defining and implementing value-based health care: a strategic framework. Acad Med. 2020;95(5):682\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchwalm J-DR, McCready T, Lamelas P, Musa H, Lopez-Jaramillo P, Yusoff K, et al. Rationale and design of a cluster randomized trial of a multifaceted intervention in people with hypertension: The Heart Outcomes Prevention and Evaluation 4 (HOPE-4) Study. Am Heart J. 2018;203:57\u0026ndash;66.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:1\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al. Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension. 2003;42(6):1206\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYang F, Katumba KR, Roudijk B, Yang Z, Revill P, Griffin S et al. Developing the EQ-5D-5L value set for Uganda using the \u0026lsquo;lite\u0026rsquo;protocol. PharmacoEconomics. 2022:1\u0026ndash;13.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSerrat-Costa M, Serra-Mart\u0026iacute;nez Y, Cabrero-Garc\u0026iacute;a J, Bertr\u0026aacute;n-Noguer C, Delclos GL, Coll-de-Tuero G, et al. A new validated international questionnaire on health professionals\u0026rsquo; knowledge of hypertension diagnosis. Hipertensi\u0026oacute;n y Riesgo Vascular. 2022;39(1):24\u0026ndash;33.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCampbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRedfern J, Adedoyin RA, Ofori S, Anchala R, Ajay VS, De Andrade L, et al. Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment. BMJ global health. 2016;1(2):e000086.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eReiss-Brennan B, Brunisholz KD, Dredge C, Briot P, Grazier K, Wilcox A, et al. Association of integrated team-based care with health care quality, utilization, and cost. JAMA. 2016;316(8):826\u0026ndash;34.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePorter ME. A strategy for health care reform\u0026mdash;toward a value-based system. N Engl J Med. 2009;361(2):109\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Value-Based Care, Hypertension, Cost-effectiveness, Health Insurance, Quality of Life, Clinical Outcomes, Patient Satisfaction, and Enhanced Financial Protection","lastPublishedDoi":"10.21203/rs.3.rs-4558011/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4558011/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eHypertension remains a major public health concern in low and middle-income countries as most hypertensive patients are not adequately treated, and improper lifestyle modification and expensive and inadequate antihypertensive medications are among the few of the challenges that hinder effective hypertension management. Evidence on which hypertensive intervention is cost-effective is essential to inform strategy, policy development, practice, implementation, and resource allocation. Value-Based Care (VBC) is a healthcare delivery model that emphasizes improving patient outcomes while optimizing costs. It shifts the focus from the volume of services provided to the value delivered to patients. We hypothesize that innovative digital VBC intervention would be more cost-effective compared to standard care among individuals with poorly controlled hypertension.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis study in Ghana will employ a mixed-methods evaluation design, a comprehensive and thorough approach that combines quantitative and qualitative methods. The quantitative component will involve a quasi-experimental study to measure the impact of the VBC intervention on quality of life, improved clinical outcomes, patient satisfaction, and enhanced financial protection among hypertensive patients registered with the National Health Insurance Authority. We will use a difference-in-difference analytic approach and a generalized estimation equation model with cluster-robust standard errors to quantify the impact of VBC, accounting for potential confounding variables. The qualitative component will involve in-depth interviews and focus group discussions to gather insights into the experiences and perceptions of the patients, caregivers, and policymakers involved in the VBC intervention and the benefits, barriers, costs of treatment, and challenges associated with the VBC intervention. We aim to provide evidence that can significantly impact hypertension service delivery in Ghana, potentially leading to more cost-effective care for hypertensive patients.\u003c/p\u003e\u003ch2\u003eDiscussions\u003c/h2\u003e \u003cp\u003eDespite the availability of safe treatment options for hypertension, most people with hypertension in LMICs do not have it controlled. There is currently a paucity of knowledge about the cost-effectiveness of VBC interventions in developing countries. This study aims to fill this knowledge gap and pave the way for more cost-effective hypertension treatment worldwide. The digital Ghana VBC intervention described in this paper is a pioneering approach to achieving safer, more consistent, and cost-effective care for hypertensive patients.\u003c/p\u003e","manuscriptTitle":"Impact of Value-Based Care on Quality of Life, Clinical Outcomes, Patient Satisfaction, and Enhanced Financial Protection among Hypertensive Patients inGhana: A Protocol for a Mixed Method Evaluation, 2024","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-07-10 01:51:27","doi":"10.21203/rs.3.rs-4558011/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7eec5cc7-dd35-484b-a227-2baa131cda6b","owner":[],"postedDate":"July 10th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-08-18T23:24:48+00:00","versionOfRecord":[],"versionCreatedAt":"2024-07-10 01:51:27","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4558011","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4558011","identity":"rs-4558011","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}