ENDO-EVE: protocol for a multicenter mixed methods evaluation of a digitally enabled tiered care pathway for endometriosis

E Richardt, K Haßdenteufel, A. Germeyer, A Marshall, A Bauer, J Andress, B Brüggenjürgen, P Martus, B Ditzen, M Zugaj, J Schlatter, M Stankovic, N Ghalekhani, C Zappe, M Wallwiener, S Wallwiener
In: Geburtshilfe und Frauenheilkunde · 2026 · vol. 86(06) , pp. e36–e37 · doi:10.1055/s-0046-1823712 · W7164160367
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The ENDO-EVE study protocol outlines a multicenter mixed-methods evaluation of a digitally enabled tiered care pathway designed to address structural deficits in endometriosis management. The research employs two linked interventions: a stepped-wedge cluster randomized trial assessing a structured referral system using an Endo-Assessment tool, and a three-arm randomized controlled trial testing a digital companion app for post-diagnosis support against usual care. As a protocol currently in its pilot phase, the main study aims to recruit approximately 775 participants to evaluate improvements in specialist-confirmed diagnosis rates, patient-reported outcomes, and care coordination. This paper is centrally about endometriosis — specifically evaluating a new digital health intervention and referral pathway aimed at improving early identification and coordinated chronic care for patients with the condition.

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Abstract

Background: Endometriosis is a common chronic gynecological disease associated with pain, impaired quality of life, reduced productivity, impaired fertility, and high healthcare costs. Diagnosis is often delayed because symptoms are normalized, structured assessment in outpatient gynecology is limited, and referral pathways to certified Endometriosis Centers (ECs) are poorly standardized. Care after referral is often fragmented, with insufficient coordination between outpatient gynecologists and ECs. Objective: ENDO-EVE evaluates whether a digitally enabled tiered care pathway can improve earlier identification, referral quality, coordinated care, and patient-reported outcomes (PROs) in routine practice. Methods: ENDO-EVE is a multicenter mixed-methods health services research project with two linked intervention components. Intervention 1 evaluates a structured referral pathway using a stepped-wedge cluster randomized trial across Halle, Heidelberg, and Tuebingen. A standardized symptom-oriented Endo-Assessment supports earlier identification and risk-informed referral of women with suspected endometriosis to certified ECs. The primary endpoint is the proportion of specialist-confirmed endometriosis among referred patients. Intervention 2 is a multicenter three-arm randomized controlled trial evaluating a digital support intervention after specialist assessment at a participating EC and confirmation of study eligibility. Participants are randomized to (1) usual care with assessment-only app, (2) app-based support, or (3) app-based support plus coach support. The digital companion includes remote symptom monitoring, longitudinal PRO collection, educational content, self-management support, reminders, event-triggered follow-up, and clinician-facing workflow integration. The primary endpoint is 12-week change in the SF-36 Physical Component
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Background

Endometriosis is a common chronic gynecological disease associated with pain, impaired quality of life, reduced productivity, impaired fertility, and high healthcare costs. Diagnosis is often delayed because symptoms are normalized, structured assessment in outpatient gynecology is limited, and referral pathways to certified Endometriosis Centers (ECs) are poorly standardized. Care after referral is often fragmented, with insufficient coordination between outpatient gynecologists and ECs.

Objective

ENDO-EVE evaluates whether a digitally enabled tiered care pathway can improve earlier identification, referral quality, coordinated care, and patient-reported outcomes (PROs) in routine practice.

Methods

ENDO-EVE is a multicenter mixed-methods health services research project with two linked intervention components. Intervention 1 evaluates a structured referral pathway using a stepped-wedge cluster randomized trial across Halle, Heidelberg, and Tuebingen. A standardized symptom-oriented Endo-Assessment supports earlier identification and risk-informed referral of women with suspected endometriosis to certified ECs. The primary endpoint is the proportion of specialist-confirmed endometriosis among referred patients. Intervention 2 is a multicenter three-arm randomized controlled trial evaluating a digital support intervention after specialist assessment at a participating EC and confirmation of study eligibility. Participants are randomized to (1) usual care with assessment-only app, (2) app-based support, or (3) app-based support plus coach support. The digital companion includes remote symptom monitoring, longitudinal PRO collection, educational content, self-management support, reminders, event-triggered follow-up, and clinician-facing workflow integration. The primary endpoint is 12-week change in the SF-36 Physical Component Summary (PCS). Secondary outcomes include pain, quality of life, self-efficacy, depressive symptoms, productivity, healthcare utilization, implementation outcomes, digital engagement, and health economic outcomes. A qualitative process evaluation examines acceptability, feasibility, and integration into routine care.

Results

ENDO-EVE is currently in the pilot phase, including validation of the Endo-Assessment and usability testing of the Digital Companion app. The main study plans to recruit approximately 775 participants. Statistical analyses include generalized estimating equations (GEE), baseline-adjusted ANCOVA, and mixed models.

Conclusion

ENDO-EVE addresses major structural deficits in endometriosis care by combining structured referral pathways with hybrid patient-facing and clinician-facing digital support. The study aims to generate scalable, patient-centered, and implementation-ready evidence for coordinated chronic gynecological care in Germany.

Keywords

endometriosis; digital health; shared care; referral pathway; patient-reported outcomes; study protocol Publication History Article published online: 10 June 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

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