The effect of family centered care on unplanned emergency room visit, hospital readmissions and intensive care admissions after abdominal surgery: a root cause analysis

The effect of family centered care on unplanned emergency room visit, hospital readmissions and intensive care admissions after abdominal surgery: a root cause analysis | 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 Research Article The effect of family centered care on unplanned emergency room visit, hospital readmissions and intensive care admissions after abdominal surgery: a root cause analysis Sani Marijke Kreca, Iris Sophie Albers, Selma Musters, Els Nieveen van Dijkum, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3997115/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 Apr, 2024 Read the published version in Patient Safety in Surgery → Version 1 posted 7 You are reading this latest preprint version Abstract Background Optimising transitional care by practicing family-centred care might reduce unplanned events for patients who undergo major abdominal cancer surgery. However, it remains unknown whether involving family caregivers in patients’ healthcare also has negative consequences for patient safety. This study assesses the safety of family involvement in patients’ healthcare by examining the cause of unplanned events in patients who participated in a family involvement programme (FIP) after major abdominal cancer surgery. Unplanned events per patient were compared between patients who received care from their family caregiver and patients who received professional at-home care after discharge. Methods This is a secondary analysis of the intervention group of a prospective cohort study. Participants in the intervention group were patients who engaged in a FIP. Unplanned events were analysed, and root causes were identified using the medical version of a prevention- and recovery-information system that analyses unintended events in healthcare. Statistical differences in the number of unplanned events were compared between patients who participated in the FIP and were cared for by their family caregiver after discharge and patients who participated in the FIP but received professional at-home care after discharge. A Mann-Whitney U test was used to analyse data. Results Of the 152 FIP participants, 68 experienced an unplanned event and were included. In total, 112 unplanned events occurred with 145 root causes since some unplanned events had several root causes. Most root causes of unplanned events were patient-related factors (n = 109, 75%), such as patient characteristics, patient conditions and disease-related factors. No root causes due to inadequate healthcare from the family caregiver were identified. Unplanned events did not differ statistically (interquartile range 1-2) ( p = 0.35) between patients who received care from trained family caregivers and those who received professional at-home care after discharge. Conclusion Active family engagement in healthcare after major abdominal cancer surgery does not lead to unexpected events such as unplanned ER visits or unplanned hospital readmissions and ICU admissions. Additionally, the risk of experiencing an unplanned event does not increase when the family caregiver provides care after hospital discharge. Family caregiver family-centred care hospital safety root cause analysis surgery Figures Figure 1 Figure 2 Introduction Adult patients who undergo major abdominal cancer surgery are at risk for significant post-operative complications, including unplanned emergency room (ER) visits, unplanned hospital readmissions and unplanned intensive care unit (ICU) admissions ( 1 – 3 ). These unplanned events can lead to worse outcomes, including increased mortality ( 2 , 4 ), risk of depression, anxiety and post-intensive-care syndrome ( 5 ). Thus, preventing these occurrences favours patient safety and well-being. The risk of complications increases in major abdominal cancer surgery patients because of the multiple transitions of care during recovery, involving various healthcare professionals during and after hospital admission ( 6 ). Poor transitional care can lead to unplanned events ( 7 ). Therefore, improving transitional care is of key importance to reduce complications and improve outcomes ( 6 , 8 ). One way to improve transitional care is to implement transitional care interventions (TCIs) in healthcare ( 8 ). Effective TCIs focus on disease self-management education, intra- and interdisciplinary communication and co-ordination of healthcare, medication management and family engagement ( 8 , 9 ). Specifically, family engagement in healthcare is a core component that is effective in reducing hospital readmissions ( 8 ), and its significance increases when family caregivers are more actively engaged in healthcare ( 8 ) because family caregivers provide continuity during care transitions. To safely engage family caregivers in healthcare, conscientiously educating and training them during in-hospital healthcare is essential ( 10 – 13 ). Therefore, an academic hospital developed and implemented a theoretically grounded family involvement programme (FIP) ( 14 , 15 ); these types of programmes and other TCIs are being developed to provide healthcare professionals with tools to improve patient outcomes by refining transitional care. Involving family in adult healthcare is practiced more often in the hospital setting, and it is relevant not only to assess its value but also to investigate its safety and potential harm. Current literature predominantly describes the positive effect on preventing adverse events when family is engaged in healthcare ( 16 ). However, in-depth research of patient safety and potential harm is currently lacking. While patients are in the hospital, healthcare professionals can address and thus prevent potential harm with the family caregiver before the family caregiver independently provides care. It remains scientifically unknown whether family caregivers can safely deliver independent, at-home care to the patient. To assess the patients’ safety, it is necessary to research ER visits, hospital readmissions and ICU admissions in an in-depth manner to illuminate unintended errors caused by family caregivers that may lead to unplanned events. Methods The primary aim in this study is to identify root causes of unplanned events in patients who underwent major abdominal cancer surgery and participated in the FIP. Unplanned events were defined as unexpected ER visits, hospital readmissions and ICU admissions. The root causes of unplanned events, which indicate errors by family caregivers, were identified to assess the safety of family engagement in post-surgical healthcare. The secondary aim is to research the safety of healthcare delivered by the family caregiver at home by comparing unplanned events in patients who participated in the FIP and were cared for by the family caregiver after discharge with patients who participated in the FIP but received professional healthcare after discharge. Study design This secondary analysis of a prospective cohort study ( 15 ) involved a root cause analysis, which was performed by researching patients’ medical files using the Prevention and Recovering information System for Monitoring and Analysis (PRISMA) medical method ( 17 ); this technique was developed to determine the causal factors of an unplanned event. Additionally, a checklist called strengthening the reporting of observational studies in epidemiology (STROBE) was used for reporting ( 18 ). Setting The multicentre prospective cohort study was performed in the surgery departments of two hospitals in the Netherlands: the Amsterdam University Medical Centre and the University Medical Centre Groningen. These departments specialise in performing major abdominal cancer surgery, and healthcare providers are trained in rendering family-centred care, according to the FIP ( 14 ). The FIP was conducted during the prospective cohort study from April 2019 through May 2022. All participants provided informed consent to participate, and the Medical Ethical Committee granted permission to conduct this study (reference number W19-497 # 20.015). Intervention Patients participated in a FIP with their family caregiver during their stay in the surgery ward; the FIP was executed post-surgery in addition to the usual post-operative care. During the FIP, family caregivers were trained by healthcare providers, including registered nurses, physical therapists and medical doctors, to execute the patient’s necessary rehabilitative healthcare. The FIP, described in detail in another article ( 14 , 15 ), comprises several components: first, setting shared goals with the patient, family caregiver and nurse; second, providing information about fundamental care activities; third, task-oriented training of family caregivers to deliver fundamental care activities; fourth, establishing physical proximity by rooming-in; and fifth, training family caregivers by requiring their presence during ward rounds ( 11 , 14 , 15 ). When patients were discharged from the hospital, they could opt to receive care from professionals or their trained family caregiver. Participants Eligible participants for this study were selected from the intervention group of the prospective cohort study since they participated in the FIP. The patients who participated in our prospective cohort study underwent major abdominal cancer surgery. This included resections of the oesophagus, stomach, colon, pancreas and liver. Patients who experienced an unplanned event were included, although patients from the control group who had an unplanned event were not included. Comparisons between the intervention and control groups are offered in the prospective cohort study. Unplanned ER visits, unplanned hospital readmissions and unplanned ICU admissions were considered to be unplanned events. One exclusion criterion was inaccessible files due to unplanned events in external hospitals. To participate in the FIP, the following criteria were applied. First, adult patients must have scheduled major abdominal cancer surgery with an expected hospital admission of at least five days post-surgery. Second, participants had to have a family caregiver who was willing to stay during the admission and participate in the patient’s healthcare under nursing supervision ( 15 ). Another exclusion criterion was any reason that may have prevented the family caregiver from performing safe patient care during the FIP, such as physical or mental impairments. Management of variables and data sources Patients who participated in the FIP and experienced an unplanned event were extracted from the database, which was created during the prospective cohort study. Patients’ demographic, social and clinical characteristics as well as the number and date of unplanned events were extracted from the database, as was the dichotomous variable of whether patients received professional healthcare after discharge. Unplanned events were measured from the date of hospital discharge to 90 days after surgery. The primary goal in this study is to determine root causes of these unplanned events and to identify errors made by family caregivers which could have led to an unplanned event. Therefore, the PRISMA medical method was used to collect, analyse and quantify information. To collect information, patients’ medical records were examined and information was extracted. Results of medical and diagnostic exams and multidisciplinary reports were evaluated. After defining the main incident in the unplanned event, causal trees were created, as illustrated in the causal tree example in the appendix in Figure A . By continually asking why something occurred, the causes of the main event were scrutinised until the root cause was exposed. To quantify these root causes, codes were assigned according to the Eindhoven classification system ( 17 ), an algorithm to classify the type of unplanned event into main- and subcategories. The number of unplanned events per patient was collected as secondary outcome. Bias To reduce the risk of information bias, unplanned events in hospitals other than the university hospital were excluded from further PRISMA analyses because information concerning external unplanned events was either not accessible or could be incomplete. Excluding external unplanned events reduced the risk of information bias, although this bias remained present due to the limitation of assessing the patients’ medical records from the university hospital only. Reports of healthcare provided by professionals, such as home care nurses or general practitioners, were not consistently present in all included medical files. To enhance reliability and objectivity, a multidisciplinary team was established, as advised in the PRISMA methodology to provide a broad spectrum of views during the evaluation of an unplanned event. Causal trees were created by two independent researchers: ISA, a medical doctor experienced in anaesthesiology and intensive care and SMK, a medium-intensive-care nurse and medical master student. Both researchers followed a training course to practice the PRISMA method. The first four anonymous causal trees were tested and evaluated within the research team, who consulted an external researcher experienced with the PRISMA method to improve unity in the system of creating causal trees. After individually evaluating the unplanned events, a second joint round of analysis occurred, after which consensus was reached under supervision of a third researcher (PRT), an experienced intensivist, epidemiologist and researcher. Study size All patients who participated in the FIP, experienced an unplanned event and had complete and accessible medical records were included in this study. Therefore, no sample size calculation was needed. Analysis Variables were tested for normality with the Shapiro-Wilk test and through evaluation of histograms. Descriptive statistics are presented as means ± standard deviations (SDs), medians and interquartile ranges (IQR) or numbers (percentages) when appropriate. For the primary outcome, the PRISMA method was used, which is a systematic method to analyse causes of unplanned events and is frequently employed in healthcare to evaluate and improve patient safety ( 17 ). Root causes were classified by the Eindhoven classification system ( 17 ), which addresses five main categories: organisational, human, technical, patient-related and unclassifiable errors. Within these categories, subcategories were defined, and codes were assigned to quantify root causes of an unplanned event ( 17 ). In addition to the Eindhoven classification system, two subcategories were added to the unclassifiable category: unclassifiable externally, coded as X-ex ; and unclassifiable—unrelated complication, coded as X-nrc . The X-ex classification was applied when the unplanned event occurred in an external hospital and the patients’ medical record was not assessable. These patients were excluded from further analysis, according to the PRISMA method. The X-nrc classification was applied when the unplanned event was a consequence of an event unrelated to the surgery or the patient’s post-surgical rehabilitation. The root causes were assigned classification codes, and then the codes were summed to determine the percentages of the total number of codes. To identify root causes which indicate an error made by the family caregiver, researchers performed the same PRISMA analysis and added another classification code to the Eindhoven classification system: unclassifiable—FIP (X-FIP). This code was also summed and presented as a percentage of the total number of codes. For the secondary aim—to evaluate the safety of the healthcare provided by the family caregiver—the median number of unplanned events per patient was compared between patients who had and did not have professional at-home care after discharge. After testing for normality using the Shapiro-Wilk test, a Mann-Whitney U test was used. This statistical analysis was performed in SPSS, version 28.0. In this study, only complete case analyses were performed. Results Participants Of the 152 FIP participants screened for eligibility, 68 patients (45%) experienced an unplanned event and were included in the analysis. In total, 116 unplanned events occurred, of which 45 were ER visits, 56 were hospital readmissions and 15 were ICU admissions. Seventeen unplanned events in 10 patients were excluded from analysis due to incomplete medical records. The enrolment of patients is presented in Fig. 1 . Patients’ characteristics and clinical characteristics are described in Table 1 . The mean age of the patients was 66.1 (± SD 10.1) years. Fifteen patients were female (22%). Of the family caregivers, 59 (87%) were partners and eight (12%) were children of the patient. Table 1 Patient characteristics Patient characteristics Demographic, social and clinical characteristics Total N = 68 Age – mean (± SD) 66.1 (10.1) Sex – number (%) -Female -Male 15 ( 22 ) 53 (78) American Society of Anesthesiologists (ASA) classification - number (%) -ASA 1 -ASA 2 -ASA 3 -ASA 4 4 (5.8) 33 (47.8) 30 (43.5) 1 (1.4) Type of resection – number (%) -Oesophageal -Gastric -Liver -Pancreatic -Colorectal -Other 25 (37) 6 ( 9 ) 6 ( 9 ) 26 (38) 2 ( 3 ) 3 ( 4 ) Polypharmacy – number (%) -Yes -No 30 (44) 38 (56) Family caregiver relationship with patient – number (%) -Partner -Child -Other 59 (87) 8 ( 12 ) 1 ( 1 ) Primary outcome Of the 68 patients who experienced an unplanned event, 40 (59%) experienced one unplanned event and 28 (41%) experienced more than one unplanned event. Types and numbers of unplanned events are described in Table 2 . Overall, 99 unplanned events were analysed using causal trees. In total, 145 root causes were found, and codes were assigned according to the Eindhoven classification system ( 17 ). Codes are defined in the appendix in Table A . Codes for root causes are presented in Fig. 2 ; most root causes were patient related (n = 109, 75%) and included disease- or patient-related factors, such as patient characteristics or conditions. Other root causes were related to technical errors (n = 5, 3%) or human errors (n = 5, 3%). Furthermore, unclassifiable root causes were determined (n = 26, 18%), of which a substantial part was unrelated to the surgery or post-surgical rehabilitation (N = 13, 9%). The code X-FIP was not seen in the data. Table 2 Descriptive statistics regarding unplanned events Descriptive statistics regarding unplanned events Descriptive data regarding unplanned events Unplanned events per patient -One -Two -More than three Total (%) 41 (60) 16 ( 24 ) 11 ( 16 ) Type of unplanned event -Emergency room visit -Hospital readmission -Intensive care unit admission -Total unplanned events Total (%) 45 (39) 56 (48) 15 ( 13 ) 116 (100) Unplanned events (total patients) Patients who received at-home care by their trained family caregiver (n = 36) Patients who received professional at-home care by nurses (n = 31) Median (interquartile range) 36.1 ( 1 – 2 ) 31.1 ( 1 – 2 ) Other* (n = 1) *Patient died during the initial hospital admission after intensive care unit admission Secondary outcome Patients who were cared for by their family caregiver after discharge had a mean of 1.61 unplanned events. Patients who received professional care by nurses had a mean of 1.81 unplanned events. This difference was not statistically significant ( p = 0.35). Discussion In this retrospective analysis of a prospective cohort study, the unplanned events in major abdominal cancer surgery patients were not related to the active engagement of family caregivers in healthcare. Moreover, most causes of unplanned events were patient related, such as disease-related complications. Furthermore, the researchers found no difference in the number of unplanned events between patients who received care from a family caregiver after discharge and patients who received professional care by nurses, which suggests that the active involvement of family caregivers does not pose a risk to patients. Family engagement in healthcare can improve patient safety ( 8 , 16 ). Scientific evidence is accumulating to underscore this improvement, although family caregivers can make unintentional errors since they are not professionally educated to provide complex care. Whether these errors occur and affect patient safety could not be determined from the current scientific literature, as studies regarding unintentional errors made by family caregivers are lacking. In the current study, family caregiver engagement did not contribute to the likelihood of an unplanned event. However, family caregiver engagement did not decrease the risk of an unplanned event, which could be explained by the determined root causes of unplanned events. Most root causes were patient related, which frequently meant a disease-related complication. Another frequent root cause was categorised as unclassifiable because of a physical complication which was not related to the initial disease, such as gallstones or cardiac arrhythmias. Such unplanned events could have been caused by multiple factors including patient characteristics but were likely not influenced by those providing healthcare. Unplanned events in this study did not decrease when the family caregiver provided care after discharge; however, other benefits can be significant but may not affect patient safety. Safe healthcare provided by family caregivers can be beneficial on several levels. For patients, family engagement can increase the safety of care transitions ( 8 ) and therefore decrease the risk of unplanned readmissions ( 8 ). Preventing unplanned readmission benefits not only the patient ( 4 ) but, for hospitals and healthcare systems, also prevents additional healthcare costs ( 1 ). Yet, there are further notable effects on a macro level. Home care facilities encounter difficulties with staff shortages ( 19 , 20 ), which increases the workload for nurses. Not only could this lead to an enhanced risk of unintended errors ( 21 – 23 ) but it could also contribute to nurses’ motivation to leave the field ( 24 ). Nursing shortages and increasing healthcare costs threaten healthcare sustainability ( 25 ), so implementing family engagement in future adult healthcare could facilitate safe solutions to providing sustainable healthcare ( 20 ). This study has both strengths and limitations. One strength was that patients’ medical records were analysed completely and objectively by trained multidisciplinary medical professionals, which enabled the acquisition of diverse insights concerning unplanned events that involve different aspects of healthcare and different healthcare professionals ( 17 , 26 ). The PRISMA method itself is another strength of this study, as it provides in-depth insight into healthcare interventions on a larger scale ( 26 ), and systematic analysis of unplanned events could indicate organisational safety flaws ( 26 ). One limitation was that reports from at-home care nurses were missing. Nevertheless, causal trees were created since ER admission reports and accounts of planned hospital visits during recovery often contained detailed information about the patients’ condition after discharge. Additionally, the retrospective design might have led to missing data when details were not reported in the patients’ medical file. Conclusion Most causes of unplanned events are patient or disease related, and unplanned events during the patients’ rehabilitation after surgery are not associated with FIP participation. Patients who receive care from their trained family caregiver after discharge do not experience more unplanned events than patients who receive professional care after discharge. Abbreviations ER Emergency room FCC Family centred care FIP Family Involvement program ICU Intensive care unit Declarations Ethics approval and consent to participate All participants gave their written informed consent to participate and the Medical Ethical Committee granted permission to conduct this study. Reference number: W19-497 # 20.015. Consent for publication Not applicable. Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests. Funding This research did not receive any grant or funding from funding agencies. Authors’ contributions SMK: Conceptualization, data curation, formal Analysis, investigation, methodology, project administration, resources, validation, visualization, Interpretation of data, writing – original draft, writing – review & editing. ISA: Data curation, analysis, interpretation of data, review & editing. SCWM: Interpretation of data, review & editing. EJMN: Interpretation of data, review & editing. PRT: Supervision, review & editing. AE: Supervision, conceptualization, interpretation of data, review & editing. Acknowledgements We would like to thank Hanneke Mertens for consulting and sharing her knowledge of PRISMA root cause analyses. Also we would like to thanks the members of the Activating Relatives To get Involved in care after Surgery (ARTIS) consortium, namely Marc M.G. Besselink MD PhD, Chris A. Bakker RN, Rosanna van Langen MSc, Marjan Ouwens RN, Barbara L. van Leeuwen MD PhD, Maarten de Jong RN, Rommy Hoekstra RN, and Reggie Smith RN. Authors’ information Qualifications & current positions SMK: RN medium intensive care, MD- student. ISA: MD, anaesthesiologist in training. SCWM: RN, MSc, PhD candidate. EJMN: MD Professor, surgeon, educator. PRT: MD PhD, intensivist, epidemiologist, educator. AME: RN, PhD, educator, lector. References Linnemann RJA, Kooijman BJL, van der Hilst CS, Sprakel J, Buis CI, Kruijff S, et al. The Costs of Complications and Unplanned Readmissions after Pancreatoduodenectomy for Pancreatic and Periampullary Tumors: Results from a Single Academic Center. Cancers (Basel). 2021;13(24). Stitzenberg KB, Chang Y, Smith AB, Nielsen ME. Exploring the burden of inpatient readmissions after major cancer surgery. J Clin Oncol. 2015;33(5):455-64. Zafar SN, Shah AA, Nembhard C, Wilson LL, Habermann EB, Raoof M, et al. Readmissions After Complex Cancer Surgery: Analysis of the Nationwide Readmissions Database. J Oncol Pract. 2018;14(6):e335-e45. Kaben A, Correa F, Reinhart K, Settmacher U, Gummert J, Kalff R, et al. Readmission to a surgical intensive care unit: incidence, outcome and risk factors. Crit Care. 2008;12(5):R123. Ito Y, Tsubaki M, Kobayashi M, Yagome S, Sakaguchi Y. Effect size estimates of risk factors for post-intensive care syndrome-family: A systematic review and meta-analysis. Heart Lung. 2023;59:1-7. Acher AW, Campbell-Flohr SA, Brenny-Fitzpatrick M, Leahy-Gross KM, Fernandes-Taylor S, Fisher AV, et al. Improving Patient-Centered Transitional Care after Complex Abdominal Surgery. J Am Coll Surg. 2017;225(2):259-65. Organization WH. Transitions of Care: Technical Series on Safer Primary Care. Geneva, Switserland: World Health Organization; 2016. p. 5. Levoy K, Rivera E, McHugh M, Hanlon A, Hirschman KB, Naylor MD. Caregiver Engagement Enhances Outcomes Among Randomized Control Trials of Transitional Care Interventions: A Systematic Review and Meta-analysis. Med Care. 2022;60(7):519-29. Park M, Giap TT, Lee M, Jeong H, Jeong M, Go Y. Patient- and family-centered care interventions for improving the quality of health care: A review of systematic reviews. Int J Nurs Stud. 2018;87:69-83. Allen J, Lobchuk M, Livingston PM, Layton N, Hutchinson AM. Informal carers' support needs, facilitators and barriers in the transitional care of older adults: A qualitative study. Health Expect. 2022;25(6):2876-92. Schreuder AM, Eskes AM, van Langen RGM, van Dieren S, Nieveen van Dijkum EJM. Active involvement of family members in postoperative care after esophageal or pancreatic resection: A feasibility study. Surgery. 2019;166(5):769-77. Fox MT, Butler JI, Sidani S, Nguyen A. Family caregivers' preparedness to support the physical activity of patients at risk for hospital readmission in rural communities: an interpretive descriptive study. BMC Health Serv Res. 2022;22(1):907. Brooks L, Stolee P, Elliott J, Heckman G. Transitional Care Experiences of Patients with Hip Fracture Across Different Health Care Settings. Int J Integr Care. 2021;21(2):2. Eskes AM, Schreuder AM, Vermeulen H, Nieveen van Dijkum EJM, Chaboyer W. Developing an evidence-based and theory informed intervention to involve families in patients care after surgery: A quality improvement project. Int J Nurs Sci. 2019;6(4):352-61. Musters SCW, Kreca S, van Dieren S, van der Wal-Huisman H, Romijn JA, Chaboyer W, et al. Activating Relatives to Get Involved in Care After Surgery: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2023;12:e38028. Khan A, Spector ND, Baird JD, Ashland M, Starmer AJ, Rosenbluth G, et al. Patient safety after implementation of a coproduced family centered communication programme: multicenter before and after intervention study. BMJ. 2018;363:k4764. Dr. T.W. van der Schaaf IMMPH. PRISMA methode medische versie Eindhoven TU/e technische universiteit eindhoven 2005. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344-9. Veenstra M, Gautun H. Nurses' assessments of staffing adequacy in care services for older patients following hospital discharge. J Adv Nurs. 2021;77(2):805-18. Felix AE. Arbeidsmarkttekorten in het sociaal domein― inspiratie uit andere sectoren en landen. Utrecht: Onderzoeksprogramma Arbeidsmarkt Zorg en Welzijn 2020. Carlesi KC, Padilha KG, Toffoletto MC, Henriquez-Roldan C, Juan MA. Patient Safety Incidents and Nursing Workload. Rev Lat Am Enfermagem. 2017;25:e2841. Di Muzio M, Dionisi S, Di Simone E, Cianfrocca C, Di Muzio F, Fabbian F, et al. Can nurses' shift work jeopardize the patient safety? A systematic review. Eur Rev Med Pharmacol Sci. 2019;23(10):4507-19. Jin H, Chen H, Munechika M, Sano M, Kajihara C. The effect of workload on nurses' non-observance errors in medication administration processes: A cross-sectional study. Int J Nurs Pract. 2018;24(5):e12679. Chan ZC, Tam WS, Lung MK, Wong WY, Chau CW. A systematic literature review of nurse shortage and the intention to leave. J Nurs Manag. 2013;21(4):605-13. Filip P. FUTURE CHALLENGES TOWARDS SUSTAINABLE HEALTHCARE. SCIENTIFIC PAPERS OF SILESIAN UNIVERSITY OF TECHNOLOGY. 2020;141. Driesen B, Baartmans M, Merten H, Otten R, Walker C, Nanayakkara PWB, et al. Root Cause Analysis Using the Prevention and Recovery Information System for Monitoring and Analysis Method in Healthcare Facilities: A Systematic Literature Review. J Patient Saf. 2022;18(4):342-50. Additional Declarations No competing interests reported. Supplementary Files Appendix.docx Cite Share Download PDF Status: Published Journal Publication published 30 Apr, 2024 Read the published version in Patient Safety in Surgery → Version 1 posted Editorial decision: Revision requested 16 Mar, 2024 Reviews received at journal 11 Mar, 2024 Reviewers agreed at journal 01 Mar, 2024 Reviewers invited by journal 01 Mar, 2024 Editor assigned by journal 29 Feb, 2024 Submission checks completed at journal 29 Feb, 2024 First submitted to journal 28 Feb, 2024 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-3997115","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":275583866,"identity":"9166dc79-8a47-48b5-ac3c-91845a8202fe","order_by":0,"name":"Sani Marijke Kreca","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA60lEQVRIiWNgGAWjYFACNjApB+Uxw4QtCGoxBmLGBiQtEgS1JDYQrUW+gS3tw4cau/T+acefP/i4x1ped0Z24gfGHbi1GBxgOzxzxrHk3Bm3cwwbZzxLN9x2I3ezBOMZPFoY2JuZeRuYcxtu5zA28xw4zAjUso2BsQ2fw4Ba/jbUp8vfTn/Y/OfAYXuCWhiADmNmbDicYHA7wbCZ4cDhRIJaDA6zJTP2HDtuuBHol5k9B9KTt515u1kiEZ/D2tuMGX7UVMvL3U5/8OHHAWvbbcdzN3742GaD22HMWEUTcGsYBaNgFIyCUUAEAAAqZleSTxBVZQAAAABJRU5ErkJggg==","orcid":"","institution":"Amsterdam UMC location Vrije Universiteit Amsterdam","correspondingAuthor":true,"prefix":"","firstName":"Sani","middleName":"Marijke","lastName":"Kreca","suffix":""},{"id":275583867,"identity":"ea719257-9e40-490b-babb-21ed50260480","order_by":1,"name":"Iris Sophie Albers","email":"","orcid":"","institution":"Amsterdam UMC location Vrije Universiteit Amsterdam","correspondingAuthor":false,"prefix":"","firstName":"Iris","middleName":"Sophie","lastName":"Albers","suffix":""},{"id":275583868,"identity":"7844cc87-dd3d-4303-ad80-c4c9e6c06c86","order_by":2,"name":"Selma Musters","email":"","orcid":"","institution":"Amsterdam UMC location University of Amsterdam","correspondingAuthor":false,"prefix":"","firstName":"Selma","middleName":"","lastName":"Musters","suffix":""},{"id":275583870,"identity":"0db31de6-8641-4083-b525-b6239436de7a","order_by":3,"name":"Els Nieveen van Dijkum","email":"","orcid":"","institution":"Amsterdam UMC location Vrije Universiteit Amsterdam","correspondingAuthor":false,"prefix":"","firstName":"Els","middleName":"Nieveen van","lastName":"Dijkum","suffix":""},{"id":275583871,"identity":"c4ef66e0-d028-48d2-85bd-bc09d1eb239d","order_by":4,"name":"Pieter Roel Tuinman","email":"","orcid":"","institution":"Amsterdam UMC location Vrije Universiteit Amsterdam","correspondingAuthor":false,"prefix":"","firstName":"Pieter","middleName":"Roel","lastName":"Tuinman","suffix":""},{"id":275583872,"identity":"6fde015d-b0a0-46a3-8742-abc1b4b48c95","order_by":5,"name":"Anne Eskes","email":"","orcid":"","institution":"Amsterdam UMC location Vrije Universiteit Amsterdam","correspondingAuthor":false,"prefix":"","firstName":"Anne","middleName":"","lastName":"Eskes","suffix":""}],"badges":[],"createdAt":"2024-02-28 15:46:13","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3997115/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3997115/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13037-024-00399-8","type":"published","date":"2024-04-30T19:58:30+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":51973865,"identity":"08578ccf-e849-443e-9c8c-d26555cf854e","added_by":"auto","created_at":"2024-03-04 19:03:47","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":59237,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eFlowchart.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e*Unplanned events in non-participating centres. Therefore, medical records were not accessible.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3997115/v1/99544d716d383b2bdd11f853.jpg"},{"id":51973866,"identity":"f792cb3f-8aa6-4b2e-a1d4-ddc700dc2291","added_by":"auto","created_at":"2024-03-04 19:03:47","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":45162,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003ePrimary outcome: root causes of unplanned events.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDRF= disease related factor. PRF= patient related factor. H-ex= human external. HKK= human knowledge-based behaviour. HRI= human related intervention. HSS= human skills-based. T-ex= technical external. TM= technical materials. X-nrc= unclassifiable, unrelated complication. X-FIP= unclassifiable, family involvement program.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-3997115/v1/f1055945f48bb281b786c741.jpg"},{"id":56042951,"identity":"9dd938f5-5e66-44f5-ba44-f897edc9eb77","added_by":"auto","created_at":"2024-05-07 20:09:23","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":512090,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3997115/v1/4eb4893f-ab6e-4c52-b411-0871b88e7311.pdf"},{"id":51973867,"identity":"0de7826f-9e37-44d2-a50c-35289c907416","added_by":"auto","created_at":"2024-03-04 19:03:47","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":117524,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix.docx","url":"https://assets-eu.researchsquare.com/files/rs-3997115/v1/f8a7119524abd684d442bb12.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"The effect of family centered care on unplanned emergency room visit, hospital readmissions and intensive care admissions after abdominal surgery: a root cause analysis","fulltext":[{"header":"Introduction","content":"\u003cp\u003eAdult patients who undergo major abdominal cancer surgery are at risk for significant post-operative complications, including unplanned emergency room (ER) visits, unplanned hospital readmissions and unplanned intensive care unit (ICU) admissions (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). These unplanned events can lead to worse outcomes, including increased mortality (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e), risk of depression, anxiety and post-intensive-care syndrome (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Thus, preventing these occurrences favours patient safety and well-being. The risk of complications increases in major abdominal cancer surgery patients because of the multiple transitions of care during recovery, involving various healthcare professionals during and after hospital admission (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Poor transitional care can lead to unplanned events (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Therefore, improving transitional care is of key importance to reduce complications and improve outcomes (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOne way to improve transitional care is to implement transitional care interventions (TCIs) in healthcare (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Effective TCIs focus on disease self-management education, intra- and interdisciplinary communication and co-ordination of healthcare, medication management and family engagement (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Specifically, family engagement in healthcare is a core component that is effective in reducing hospital readmissions (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), and its significance increases when family caregivers are more actively engaged in healthcare (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) because family caregivers provide continuity during care transitions. To safely engage family caregivers in healthcare, conscientiously educating and training them during in-hospital healthcare is essential (\u003cspan additionalcitationids=\"CR11 CR12\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Therefore, an academic hospital developed and implemented a theoretically grounded family involvement programme (FIP) (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e); these types of programmes and other TCIs are being developed to provide healthcare professionals with tools to improve patient outcomes by refining transitional care.\u003c/p\u003e \u003cp\u003eInvolving family in adult healthcare is practiced more often in the hospital setting, and it is relevant not only to assess its value but also to investigate its safety and potential harm. Current literature predominantly describes the positive effect on preventing adverse events when family is engaged in healthcare (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). However, in-depth research of patient safety and potential harm is currently lacking. While patients are in the hospital, healthcare professionals can address and thus prevent potential harm with the family caregiver before the family caregiver independently provides care. It remains scientifically unknown whether family caregivers can safely deliver independent, at-home care to the patient. To assess the patients\u0026rsquo; safety, it is necessary to research ER visits, hospital readmissions and ICU admissions in an in-depth manner to illuminate unintended errors caused by family caregivers that may lead to unplanned events.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThe primary aim in this study is to identify root causes of unplanned events in patients who underwent major abdominal cancer surgery and participated in the FIP. Unplanned events were defined as unexpected ER visits, hospital readmissions and ICU admissions. The root causes of unplanned events, which indicate errors by family caregivers, were identified to assess the safety of family engagement in post-surgical healthcare. The secondary aim is to research the safety of healthcare delivered by the family caregiver at home by comparing unplanned events in patients who participated in the FIP and were cared for by the family caregiver after discharge with patients who participated in the FIP but received professional healthcare after discharge.\u003c/p\u003e \u003cp\u003eStudy design\u003c/p\u003e \u003cp\u003eThis secondary analysis of a prospective cohort study (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) involved a root cause analysis, which was performed by researching patients\u0026rsquo; medical files using the Prevention and Recovering information System for Monitoring and Analysis (PRISMA) medical method (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e); this technique was developed to determine the causal factors of an unplanned event. Additionally, a checklist called \u003cem\u003estrengthening the reporting of observational studies in epidemiology\u003c/em\u003e (STROBE) was used for reporting (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSetting\u003c/p\u003e \u003cp\u003eThe multicentre prospective cohort study was performed in the surgery departments of two hospitals in the Netherlands: the Amsterdam University Medical Centre and the University Medical Centre Groningen. These departments specialise in performing major abdominal cancer surgery, and healthcare providers are trained in rendering family-centred care, according to the FIP (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). The FIP was conducted during the prospective cohort study from April 2019 through May 2022. All participants provided informed consent to participate, and the Medical Ethical Committee granted permission to conduct this study (reference number W19-497 # 20.015).\u003c/p\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003ePatients participated in a FIP with their family caregiver during their stay in the surgery ward; the FIP was executed post-surgery in addition to the usual post-operative care. During the FIP, family caregivers were trained by healthcare providers, including registered nurses, physical therapists and medical doctors, to execute the patient\u0026rsquo;s necessary rehabilitative healthcare. The FIP, described in detail in another article (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e), comprises several components: first, setting shared goals with the patient, family caregiver and nurse; second, providing information about fundamental care activities; third, task-oriented training of family caregivers to deliver fundamental care activities; fourth, establishing physical proximity by rooming-in; and fifth, training family caregivers by requiring their presence during ward rounds (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). When patients were discharged from the hospital, they could opt to receive care from professionals or their trained family caregiver.\u003c/p\u003e \u003cp\u003eParticipants\u003c/p\u003e \u003cp\u003eEligible participants for this study were selected from the intervention group of the prospective cohort study since they participated in the FIP. The patients who participated in our prospective cohort study underwent major abdominal cancer surgery. This included resections of the oesophagus, stomach, colon, pancreas and liver. Patients who experienced an unplanned event were included, although patients from the control group who had an unplanned event were not included. Comparisons between the intervention and control groups are offered in the prospective cohort study. Unplanned ER visits, unplanned hospital readmissions and unplanned ICU admissions were considered to be unplanned events. One exclusion criterion was inaccessible files due to unplanned events in external hospitals.\u003c/p\u003e \u003cp\u003eTo participate in the FIP, the following criteria were applied. First, adult patients must have scheduled major abdominal cancer surgery with an expected hospital admission of at least five days post-surgery. Second, participants had to have a family caregiver who was willing to stay during the admission and participate in the patient\u0026rsquo;s healthcare under nursing supervision (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Another exclusion criterion was any reason that may have prevented the family caregiver from performing safe patient care during the FIP, such as physical or mental impairments.\u003c/p\u003e \u003cp\u003eManagement of variables and data sources\u003c/p\u003e \u003cp\u003ePatients who participated in the FIP and experienced an unplanned event were extracted from the database, which was created during the prospective cohort study. Patients\u0026rsquo; demographic, social and clinical characteristics as well as the number and date of unplanned events were extracted from the database, as was the dichotomous variable of whether patients received professional healthcare after discharge. Unplanned events were measured from the date of hospital discharge to 90 days after surgery.\u003c/p\u003e \u003cp\u003eThe primary goal in this study is to determine root causes of these unplanned events and to identify errors made by family caregivers which could have led to an unplanned event. Therefore, the PRISMA medical method was used to collect, analyse and quantify information. To collect information, patients\u0026rsquo; medical records were examined and information was extracted. Results of medical and diagnostic exams and multidisciplinary reports were evaluated. After defining the main incident in the unplanned event, causal trees were created, as illustrated in the causal tree example in the \u003cspan refid=\"Sec6\" class=\"InternalRef\"\u003eappendix\u003c/span\u003e in \u003cb\u003eFigure A\u003c/b\u003e. By continually asking why something occurred, the causes of the main event were scrutinised until the root cause was exposed. To quantify these root causes, codes were assigned according to the Eindhoven classification system (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e), an algorithm to classify the type of unplanned event into main- and subcategories. The number of unplanned events per patient was collected as secondary outcome.\u003c/p\u003e \u003cp\u003eBias\u003c/p\u003e \u003cp\u003eTo reduce the risk of information bias, unplanned events in hospitals other than the university hospital were excluded from further PRISMA analyses because information concerning external unplanned events was either not accessible or could be incomplete. Excluding external unplanned events reduced the risk of information bias, although this bias remained present due to the limitation of assessing the patients\u0026rsquo; medical records from the university hospital only. Reports of healthcare provided by professionals, such as home care nurses or general practitioners, were not consistently present in all included medical files.\u003c/p\u003e \u003cp\u003eTo enhance reliability and objectivity, a multidisciplinary team was established, as advised in the PRISMA methodology to provide a broad spectrum of views during the evaluation of an unplanned event. Causal trees were created by two independent researchers: ISA, a medical doctor experienced in anaesthesiology and intensive care and SMK, a medium-intensive-care nurse and medical master student. Both researchers followed a training course to practice the PRISMA method. The first four anonymous causal trees were tested and evaluated within the research team, who consulted an external researcher experienced with the PRISMA method to improve unity in the system of creating causal trees. After individually evaluating the unplanned events, a second joint round of analysis occurred, after which consensus was reached under supervision of a third researcher (PRT), an experienced intensivist, epidemiologist and researcher.\u003c/p\u003e \u003cp\u003eStudy size\u003c/p\u003e \u003cp\u003eAll patients who participated in the FIP, experienced an unplanned event and had complete and accessible medical records were included in this study. Therefore, no sample size calculation was needed.\u003c/p\u003e \u003cp\u003eAnalysis\u003c/p\u003e \u003cp\u003eVariables were tested for normality with the Shapiro-Wilk test and through evaluation of histograms. Descriptive statistics are presented as means\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviations (SDs), medians and interquartile ranges (IQR) or numbers (percentages) when appropriate.\u003c/p\u003e \u003cp\u003eFor the primary outcome, the PRISMA method was used, which is a systematic method to analyse causes of unplanned events and is frequently employed in healthcare to evaluate and improve patient safety (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Root causes were classified by the Eindhoven classification system (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e), which addresses five main categories: organisational, human, technical, patient-related and unclassifiable errors. Within these categories, subcategories were defined, and codes were assigned to quantify root causes of an unplanned event (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). In addition to the Eindhoven classification system, two subcategories were added to the unclassifiable category: unclassifiable externally, coded as \u003cem\u003eX-ex\u003c/em\u003e; and unclassifiable\u0026mdash;unrelated complication, coded as \u003cem\u003eX-nrc\u003c/em\u003e. The X-ex classification was applied when the unplanned event occurred in an external hospital and the patients\u0026rsquo; medical record was not assessable. These patients were excluded from further analysis, according to the PRISMA method. The X-nrc classification was applied when the unplanned event was a consequence of an event unrelated to the surgery or the patient\u0026rsquo;s post-surgical rehabilitation. The root causes were assigned classification codes, and then the codes were summed to determine the percentages of the total number of codes. To identify root causes which indicate an error made by the family caregiver, researchers performed the same PRISMA analysis and added another classification code to the Eindhoven classification system: unclassifiable\u0026mdash;FIP (X-FIP). This code was also summed and presented as a percentage of the total number of codes.\u003c/p\u003e \u003cp\u003eFor the secondary aim\u0026mdash;to evaluate the safety of the healthcare provided by the family caregiver\u0026mdash;the median number of unplanned events per patient was compared between patients who had and did not have professional at-home care after discharge. After testing for normality using the Shapiro-Wilk test, a Mann-Whitney U test was used. This statistical analysis was performed in SPSS, version 28.0. In this study, only complete case analyses were performed.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eParticipants\u003c/p\u003e\n\u003cp\u003eOf the 152 FIP participants screened for eligibility, 68 patients (45%) experienced an unplanned event and were included in the analysis. In total, 116 unplanned events occurred, of which 45 were ER visits, 56 were hospital readmissions and 15 were ICU admissions. Seventeen unplanned events in 10 patients were excluded from analysis due to incomplete medical records. The enrolment of patients is presented in Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e. Patients\u0026rsquo; characteristics and clinical characteristics are described in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e. The mean age of the patients was 66.1 (\u0026plusmn;\u0026thinsp;SD 10.1) years. Fifteen patients were female (22%). Of the family caregivers, 59 (87%) were partners and eight (12%) were children of the patient.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u0026nbsp;\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003ePatient characteristics\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003ePatient characteristics\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eDemographic, social and clinical characteristics\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eTotal N\u0026nbsp;= 68\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAge \u0026ndash; mean (\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e66.1 (10.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSex \u0026ndash; number (%)\u003c/p\u003e\n \u003cp\u003e-Female\u003c/p\u003e\n \u003cp\u003e-Male\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e15 (\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003e53 (78)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAmerican Society of Anesthesiologists (ASA) classification - number (%)\u003c/p\u003e\n \u003cp\u003e-ASA 1\u003c/p\u003e\n \u003cp\u003e-ASA 2\u003c/p\u003e\n \u003cp\u003e-ASA 3\u003c/p\u003e\n \u003cp\u003e-ASA 4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (5.8)\u003c/p\u003e\n \u003cp\u003e33 (47.8)\u003c/p\u003e\n \u003cp\u003e30 (43.5)\u003c/p\u003e\n \u003cp\u003e1 (1.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eType of resection \u0026ndash; number (%)\u003c/p\u003e\n \u003cp\u003e-Oesophageal\u003c/p\u003e\n \u003cp\u003e-Gastric\u003c/p\u003e\n \u003cp\u003e-Liver\u003c/p\u003e\n \u003cp\u003e-Pancreatic\u003c/p\u003e\n \u003cp\u003e-Colorectal\u003c/p\u003e\n \u003cp\u003e-Other\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e25 (37)\u003c/p\u003e\n \u003cp\u003e6 (\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003e6 (\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003e26 (38)\u003c/p\u003e\n \u003cp\u003e2 (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003e3 (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePolypharmacy \u0026ndash; number (%)\u003c/p\u003e\n \u003cp\u003e-Yes\u003c/p\u003e\n \u003cp\u003e-No\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e30 (44)\u003c/p\u003e\n \u003cp\u003e38 (56)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFamily caregiver relationship with patient \u0026ndash; number (%)\u003c/p\u003e\n \u003cp\u003e-Partner\u003c/p\u003e\n \u003cp\u003e-Child\u003c/p\u003e\n \u003cp\u003e-Other\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e59 (87)\u003c/p\u003e\n \u003cp\u003e8 (\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003e1 (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003ePrimary outcome\u003c/p\u003e\n\u003cp\u003eOf the 68 patients who experienced an unplanned event, 40 (59%) experienced one unplanned event and 28 (41%) experienced more than one unplanned event. Types and numbers of unplanned events are described in Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e. Overall, 99 unplanned events were analysed using causal trees.\u003c/p\u003e\n\u003cp\u003eIn total, 145 root causes were found, and codes were assigned according to the Eindhoven classification system (\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e). Codes are defined in the \u003cspan class=\"InternalRef\"\u003eappendix\u003c/span\u003e in \u003cstrong\u003eTable A\u003c/strong\u003e. Codes for root causes are presented in Fig. \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e; most root causes were patient related (n\u0026thinsp;=\u0026thinsp;109, 75%) and included disease- or patient-related factors, such as patient characteristics or conditions. Other root causes were related to technical errors (n\u0026thinsp;=\u0026thinsp;5, 3%) or human errors (n\u0026thinsp;=\u0026thinsp;5, 3%). Furthermore, unclassifiable root causes were determined (n\u0026thinsp;=\u0026thinsp;26, 18%), of which a substantial part was unrelated to the surgery or post-surgical rehabilitation (N\u0026thinsp;=\u0026thinsp;13, 9%). The code \u003cem\u003eX-FIP\u003c/em\u003e was not seen in the data.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u0026nbsp;\u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eDescriptive statistics regarding unplanned events\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eDescriptive statistics regarding unplanned events\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eDescriptive data regarding unplanned events\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUnplanned events per patient\u003c/p\u003e\n \u003cp\u003e-One\u003c/p\u003e\n \u003cp\u003e-Two\u003c/p\u003e\n \u003cp\u003e-More than three\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTotal (%)\u003c/p\u003e\n \u003cp\u003e41 (60)\u003c/p\u003e\n \u003cp\u003e16 (\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003e11 (\u003cspan class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eType of unplanned event\u003c/p\u003e\n \u003cp\u003e-Emergency room visit\u003c/p\u003e\n \u003cp\u003e-Hospital readmission\u003c/p\u003e\n \u003cp\u003e-Intensive care unit admission\u003c/p\u003e\n \u003cp\u003e-Total unplanned events\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTotal (%)\u003c/p\u003e\n \u003cp\u003e45 (39)\u003c/p\u003e\n \u003cp\u003e56 (48)\u003c/p\u003e\n \u003cp\u003e15 (\u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003e116 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUnplanned events (total patients)\u003c/p\u003e\n \u003cp\u003ePatients who received at-home care by their trained family caregiver (n\u0026nbsp;=\u0026nbsp;36)\u003c/p\u003e\n \u003cp\u003ePatients who received professional at-home care by nurses (n\u0026nbsp;=\u0026nbsp;31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMedian (interquartile range)\u003c/p\u003e\n \u003cp\u003e36.1 (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003e31.1 (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eOther* (n\u0026nbsp;=\u0026nbsp;1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e*Patient died during the initial hospital admission after intensive care unit admission\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSecondary outcome\u003c/p\u003e\n\u003cp\u003ePatients who were cared for by their family caregiver after discharge had a mean of 1.61 unplanned events. Patients who received professional care by nurses had a mean of 1.81 unplanned events. This difference was not statistically significant (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.35).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this retrospective analysis of a prospective cohort study, the unplanned events in major abdominal cancer surgery patients were not related to the active engagement of family caregivers in healthcare. Moreover, most causes of unplanned events were patient related, such as disease-related complications. Furthermore, the researchers found no difference in the number of unplanned events between patients who received care from a family caregiver after discharge and patients who received professional care by nurses, which suggests that the active involvement of family caregivers does not pose a risk to patients.\u003c/p\u003e \u003cp\u003eFamily engagement in healthcare can improve patient safety (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Scientific evidence is accumulating to underscore this improvement, although family caregivers can make unintentional errors since they are not professionally educated to provide complex care. Whether these errors occur and affect patient safety could not be determined from the current scientific literature, as studies regarding unintentional errors made by family caregivers are lacking. In the current study, family caregiver engagement did not contribute to the likelihood of an unplanned event. However, family caregiver engagement did not decrease the risk of an unplanned event, which could be explained by the determined root causes of unplanned events. Most root causes were patient related, which frequently meant a disease-related complication. Another frequent root cause was categorised as unclassifiable because of a physical complication which was not related to the initial disease, such as gallstones or cardiac arrhythmias. Such unplanned events could have been caused by multiple factors including patient characteristics but were likely not influenced by those providing healthcare. Unplanned events in this study did not decrease when the family caregiver provided care after discharge; however, other benefits can be significant but may not affect patient safety.\u003c/p\u003e \u003cp\u003eSafe healthcare provided by family caregivers can be beneficial on several levels. For patients, family engagement can increase the safety of care transitions (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) and therefore decrease the risk of unplanned readmissions (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Preventing unplanned readmission benefits not only the patient (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) but, for hospitals and healthcare systems, also prevents additional healthcare costs (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Yet, there are further notable effects on a macro level. Home care facilities encounter difficulties with staff shortages (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e), which increases the workload for nurses. Not only could this lead to an enhanced risk of unintended errors (\u003cspan additionalcitationids=\"CR22\" citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e) but it could also contribute to nurses\u0026rsquo; motivation to leave the field (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Nursing shortages and increasing healthcare costs threaten healthcare sustainability (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e), so implementing family engagement in future adult healthcare could facilitate safe solutions to providing sustainable healthcare (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThis study has both strengths and limitations. One strength was that patients\u0026rsquo; medical records were analysed completely and objectively by trained multidisciplinary medical professionals, which enabled the acquisition of diverse insights concerning unplanned events that involve different aspects of healthcare and different healthcare professionals (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). The PRISMA method itself is another strength of this study, as it provides in-depth insight into healthcare interventions on a larger scale (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e), and systematic analysis of unplanned events could indicate organisational safety flaws (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). One limitation was that reports from at-home care nurses were missing. Nevertheless, causal trees were created since ER admission reports and accounts of planned hospital visits during recovery often contained detailed information about the patients\u0026rsquo; condition after discharge. Additionally, the retrospective design might have led to missing data when details were not reported in the patients\u0026rsquo; medical file.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eMost causes of unplanned events are patient or disease related, and unplanned events during the patients\u0026rsquo; rehabilitation after surgery are not associated with FIP participation. Patients who receive care from their trained family caregiver after discharge do not experience more unplanned events than patients who receive professional care after discharge.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e\u003cstrong\u003eER\u003c/strong\u003e Emergency room\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFCC\u003c/strong\u003e Family centred care\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFIP\u003c/strong\u003e Family Involvement program\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eICU\u003c/strong\u003e Intensive care unit\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll participants gave their written informed consent to participate and the Medical Ethical Committee granted permission to conduct this study. Reference number: W19-497 # 20.015.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u0026nbsp;\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 did not receive any grant or funding from funding agencies.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSMK: Conceptualization, data curation, formal Analysis, investigation, methodology, project administration, resources, validation, visualization, Interpretation of data, writing \u0026ndash; original draft, writing \u0026ndash; review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003eISA: Data curation, analysis, interpretation of data, review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003eSCWM: Interpretation of data, review \u0026amp; editing.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEJMN: Interpretation of data, review \u0026amp; editing.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePRT: Supervision, review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003eAE: Supervision, conceptualization, interpretation of data, review \u0026amp; editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank Hanneke Mertens for consulting and sharing her knowledge of PRISMA root cause analyses. Also we would like to thanks the members of the Activating Relatives To get Involved in care after Surgery (ARTIS) consortium, namely\u0026nbsp;Marc M.G. Besselink MD PhD, Chris A. Bakker RN, Rosanna van Langen MSc, Marjan Ouwens RN, Barbara L. van Leeuwen MD PhD, Maarten de Jong RN, Rommy Hoekstra RN, and Reggie Smith RN.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; information \u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eQualifications \u0026amp; current positions\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSMK: RN medium intensive care, MD- student.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eISA: MD, anaesthesiologist in training.\u003c/p\u003e\n\u003cp\u003eSCWM: RN, MSc, PhD candidate.\u003c/p\u003e\n\u003cp\u003eEJMN: MD Professor, surgeon, educator.\u003c/p\u003e\n\u003cp\u003ePRT: MD PhD, intensivist, epidemiologist, educator.\u003c/p\u003e\n\u003cp\u003eAME: RN, PhD, educator, lector.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eLinnemann RJA, Kooijman BJL, van der Hilst CS, Sprakel J, Buis CI, Kruijff S, et al. The Costs of Complications and Unplanned Readmissions after Pancreatoduodenectomy for Pancreatic and Periampullary Tumors: Results from a Single Academic Center. Cancers (Basel). 2021;13(24).\u003c/li\u003e\n\u003cli\u003eStitzenberg KB, Chang Y, Smith AB, Nielsen ME. Exploring the burden of inpatient readmissions after major cancer surgery. J Clin Oncol. 2015;33(5):455-64.\u003c/li\u003e\n\u003cli\u003eZafar SN, Shah AA, Nembhard C, Wilson LL, Habermann EB, Raoof M, et al. Readmissions After Complex Cancer Surgery: Analysis of the Nationwide Readmissions Database. J Oncol Pract. 2018;14(6):e335-e45.\u003c/li\u003e\n\u003cli\u003eKaben A, Correa F, Reinhart K, Settmacher U, Gummert J, Kalff R, et al. Readmission to a surgical intensive care unit: incidence, outcome and risk factors. Crit Care. 2008;12(5):R123.\u003c/li\u003e\n\u003cli\u003eIto Y, Tsubaki M, Kobayashi M, Yagome S, Sakaguchi Y. Effect size estimates of risk factors for post-intensive care syndrome-family: A systematic review and meta-analysis. Heart Lung. 2023;59:1-7.\u003c/li\u003e\n\u003cli\u003eAcher AW, Campbell-Flohr SA, Brenny-Fitzpatrick M, Leahy-Gross KM, Fernandes-Taylor S, Fisher AV, et al. Improving Patient-Centered Transitional Care after Complex Abdominal Surgery. J Am Coll Surg. 2017;225(2):259-65.\u003c/li\u003e\n\u003cli\u003eOrganization WH. Transitions of Care: Technical Series on Safer Primary Care. Geneva, Switserland: World Health Organization; 2016. p. 5.\u003c/li\u003e\n\u003cli\u003eLevoy K, Rivera E, McHugh M, Hanlon A, Hirschman KB, Naylor MD. Caregiver Engagement Enhances Outcomes Among Randomized Control Trials of Transitional Care Interventions: A Systematic Review and Meta-analysis. Med Care. 2022;60(7):519-29.\u003c/li\u003e\n\u003cli\u003ePark M, Giap TT, Lee M, Jeong H, Jeong M, Go Y. Patient- and family-centered care interventions for improving the quality of health care: A review of systematic reviews. Int J Nurs Stud. 2018;87:69-83.\u003c/li\u003e\n\u003cli\u003eAllen J, Lobchuk M, Livingston PM, Layton N, Hutchinson AM. Informal carers\u0026apos; support needs, facilitators and barriers in the transitional care of older adults: A qualitative study. Health Expect. 2022;25(6):2876-92.\u003c/li\u003e\n\u003cli\u003eSchreuder AM, Eskes AM, van Langen RGM, van Dieren S, Nieveen van Dijkum EJM. Active involvement of family members in postoperative care after esophageal or pancreatic resection: A feasibility study. Surgery. 2019;166(5):769-77.\u003c/li\u003e\n\u003cli\u003eFox MT, Butler JI, Sidani S, Nguyen A. Family caregivers\u0026apos; preparedness to support the physical activity of patients at risk for hospital readmission in rural communities: an interpretive descriptive study. BMC Health Serv Res. 2022;22(1):907.\u003c/li\u003e\n\u003cli\u003eBrooks L, Stolee P, Elliott J, Heckman G. Transitional Care Experiences of Patients with Hip Fracture Across Different Health Care Settings. Int J Integr Care. 2021;21(2):2.\u003c/li\u003e\n\u003cli\u003eEskes AM, Schreuder AM, Vermeulen H, Nieveen van Dijkum EJM, Chaboyer W. Developing an evidence-based and theory informed intervention to involve families in patients care after surgery: A quality improvement project. Int J Nurs Sci. 2019;6(4):352-61.\u003c/li\u003e\n\u003cli\u003eMusters SCW, Kreca S, van Dieren S, van der Wal-Huisman H, Romijn JA, Chaboyer W, et al. Activating Relatives to Get Involved in Care After Surgery: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2023;12:e38028.\u003c/li\u003e\n\u003cli\u003eKhan A, Spector ND, Baird JD, Ashland M, Starmer AJ, Rosenbluth G, et al. Patient safety after implementation of a coproduced family centered communication programme: multicenter before and after intervention study. BMJ. 2018;363:k4764.\u003c/li\u003e\n\u003cli\u003eDr. T.W. van der Schaaf IMMPH. PRISMA methode medische versie Eindhoven TU/e technische universiteit eindhoven 2005.\u003c/li\u003e\n\u003cli\u003evon Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344-9.\u003c/li\u003e\n\u003cli\u003eVeenstra M, Gautun H. Nurses\u0026apos; assessments of staffing adequacy in care services for older patients following hospital discharge. J Adv Nurs. 2021;77(2):805-18.\u003c/li\u003e\n\u003cli\u003eFelix AE. Arbeidsmarkttekorten in het sociaal domein― inspiratie uit andere sectoren en landen. Utrecht: Onderzoeksprogramma Arbeidsmarkt Zorg en Welzijn 2020.\u003c/li\u003e\n\u003cli\u003eCarlesi KC, Padilha KG, Toffoletto MC, Henriquez-Roldan C, Juan MA. Patient Safety Incidents and Nursing Workload. Rev Lat Am Enfermagem. 2017;25:e2841.\u003c/li\u003e\n\u003cli\u003eDi Muzio M, Dionisi S, Di Simone E, Cianfrocca C, Di Muzio F, Fabbian F, et al. Can nurses\u0026apos; shift work jeopardize the patient safety? A systematic review. Eur Rev Med Pharmacol Sci. 2019;23(10):4507-19.\u003c/li\u003e\n\u003cli\u003eJin H, Chen H, Munechika M, Sano M, Kajihara C. The effect of workload on nurses\u0026apos; non-observance errors in medication administration processes: A cross-sectional study. Int J Nurs Pract. 2018;24(5):e12679.\u003c/li\u003e\n\u003cli\u003eChan ZC, Tam WS, Lung MK, Wong WY, Chau CW. A systematic literature review of nurse shortage and the intention to leave. J Nurs Manag. 2013;21(4):605-13.\u003c/li\u003e\n\u003cli\u003eFilip P. FUTURE CHALLENGES TOWARDS SUSTAINABLE HEALTHCARE. SCIENTIFIC PAPERS OF SILESIAN UNIVERSITY OF TECHNOLOGY. 2020;141.\u003c/li\u003e\n\u003cli\u003eDriesen B, Baartmans M, Merten H, Otten R, Walker C, Nanayakkara PWB, et al. Root Cause Analysis Using the Prevention and Recovery Information System for Monitoring and Analysis Method in Healthcare Facilities: A Systematic Literature Review. J Patient Saf. 2022;18(4):342-50.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"patient-safety-in-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"psis","sideBox":"Learn more about [Patient Safety in Surgery](http://pssjournal.biomedcentral.com/)","snPcode":"13037","submissionUrl":"https://submission.nature.com/new-submission/13037/3","title":"Patient Safety in Surgery","twitterHandle":"@EMSurgeryBMC","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Family caregiver, family-centred care, hospital, safety, root cause analysis, surgery","lastPublishedDoi":"10.21203/rs.3.rs-3997115/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3997115/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003eBackground\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOptimising transitional care by practicing family-centred care might reduce unplanned events for patients who undergo major abdominal cancer surgery. However, it remains unknown whether involving family caregivers in patients’ healthcare also has negative consequences for patient safety. This study assesses the safety of family involvement in patients’ healthcare by examining the cause of unplanned events in patients who participated in a family involvement programme (FIP) after major abdominal cancer surgery. Unplanned events per patient were compared between patients who received care from their family caregiver and patients who received professional at-home care after discharge.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMethods\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis is a secondary analysis of the intervention group of a prospective cohort study. Participants in the intervention group were patients who engaged in a FIP. Unplanned events were analysed, and root causes were identified using the medical version of a prevention- and recovery-information system that analyses unintended events in healthcare. Statistical differences in the number of unplanned events were compared between patients who participated in the FIP and were cared for by their family caregiver after discharge and patients who participated in the FIP but received professional at-home care after discharge. A Mann-Whitney U test was used to analyse data.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eResults\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOf the 152 FIP participants, 68 experienced an unplanned event and were included. In total, 112 unplanned events occurred with 145 root causes since some unplanned events had several root causes. Most root causes of unplanned events were patient-related factors (n = 109, 75%), such as patient characteristics, patient conditions and disease-related factors. No root causes due to inadequate healthcare from the family caregiver were identified. Unplanned events did not differ statistically (interquartile range 1-2) (\u003cem\u003ep\u003c/em\u003e = 0.35) between patients who received care from trained family caregivers and those who received professional at-home care after discharge.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConclusion\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eActive family engagement in healthcare after major abdominal cancer surgery does not lead to unexpected events such as unplanned ER visits or unplanned hospital readmissions and ICU admissions. Additionally, the risk of experiencing an unplanned event does not increase when the family caregiver provides care after hospital discharge.\u003c/p\u003e","manuscriptTitle":"The effect of family centered care on unplanned emergency room visit, hospital readmissions and intensive care admissions after abdominal surgery: a root cause analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-04 19:03:42","doi":"10.21203/rs.3.rs-3997115/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-03-16T14:25:43+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-03-11T16:27:25+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"5f5edffd-a0b1-4388-83b6-c9d8f58ef833","date":"2024-03-01T11:03:14+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-03-01T10:54:24+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-02-29T11:34:32+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-02-29T06:32:46+00:00","index":"","fulltext":""},{"type":"submitted","content":"Patient Safety in Surgery","date":"2024-02-28T15:36:14+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"patient-safety-in-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"psis","sideBox":"Learn more about [Patient Safety in Surgery](http://pssjournal.biomedcentral.com/)","snPcode":"13037","submissionUrl":"https://submission.nature.com/new-submission/13037/3","title":"Patient Safety in Surgery","twitterHandle":"@EMSurgeryBMC","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e0776f74-7707-460e-aad7-1cd4a4793539","owner":[],"postedDate":"March 4th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-05-07T20:04:47+00:00","versionOfRecord":{"articleIdentity":"rs-3997115","link":"https://doi.org/10.1186/s13037-024-00399-8","journal":{"identity":"patient-safety-in-surgery","isVorOnly":false,"title":"Patient Safety in Surgery"},"publishedOn":"2024-04-30 19:58:30","publishedOnDateReadable":"April 30th, 2024"},"versionCreatedAt":"2024-03-04 19:03:42","video":"","vorDoi":"10.1186/s13037-024-00399-8","vorDoiUrl":"https://doi.org/10.1186/s13037-024-00399-8","workflowStages":[]},"version":"v1","identity":"rs-3997115","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3997115","identity":"rs-3997115","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}