EMBOSS: reach and Effect of a person-centred integrated-care approach for chronic diseases and MultimorBidity in patients of low sOcio- economic StatuS in general practice.

Person-centred and integrated care (PC-IC) aims to align healthcare with patients’ values and life circumstances potentially improving self-management, satisfaction, and health outcomes. This approach is particularly relevant for patients with low socioeconomic status (LSES), who often face chronic diseases, low health literacy, and barriers to care. Evidence on PC-IC effectiveness for LSES patients with chronic diseases remains limited.
We conducted a cluster randomised controlled trial with 22 Dutch general practices across six regions, targeting LSES patients with chronic diseases. The intervention group received the recently in co-creation developed PC-IC approach, while the control group continued the current protocolised single-disease management programs (sDMPs). Patient-reported outcomes on health status, care experiences, and engagement were collected at baseline, six and twelve months. The primary outcome was a composite of the PROMIS Global 10 GPH, PROMIS Global 10 GMH, and P3CEQ. GPs and PNs completed questionnaires on experiences and works satisfaction. Multilevel logistic regression was used for the primary outcome; secondary outcome measures were analysed using multilevel linear models.
A total of 231 patients participated (93 intervention, 138 control),and 70 healthcare providers (35 intervention, 35 control group).
All the data obtained in this project will be stored in the Radboud Data Repository (RDR) and will be kept for 15 years. Individual participant data are not publicly available because participants did not consent to open data sharing. All data that can be made available including meta data, study protocol, codebooks, can be found in the RDR.

Codebook Healthcare providers: GPs and PNs completed questionnaires at baseline, 6, and 12 months assessing experiences with the PC-IC approach (COPILOT, 0–10; MAS-GZ, 1–5), alongside demographic and professional characteristics such as consent, age, gender, role, education, practice type, and work experience.

Codebook patients: Patient-reported outcomes were collected at baseline, 6, and 12 months to assess health status, care experiences, and patient engagement (PROMIS Global-10, P3CEQ, PAM-13, EQ-5D-5L/EQ-VAS), alongside lifestyle factors (smoking, alcohol use, physical activity) and sociodemographic characteristics (e.g., age, gender, education, health literacy, and occupation).

Study protocol :The study was conducted according to a predefined protocol, including the study design, study population, intervention, study procedures, outcome measures, and planned statistical analysis.