The SOFIA pilot study: assessing feasibility and fidelity of coordinated care to reduce excess mortality and increase quality of life in patients with severe mental illness in a general practice setting; a cluster-randomised pilot trial.

Autor: Tranberg K; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark. katrine.tranberg.jensen@sund.ku.dk., Jønsson A; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.; Department of People and Technology, Roskilde University, Roskilde, Denmark.; Department of Community Medicine, Faculty of Health Sciences, The Research Unit for General Practice, UiT The Arctic University of Norway, Tromsø, Norway., Due T; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.; The Mental health services in the Capital Region of Denmark, Copenhagen, Denmark., Siersma V; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark., Brodersen JB; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.; Department of Community Medicine, Faculty of Health Sciences, The Research Unit for General Practice, UiT The Arctic University of Norway, Tromsø, Norway.; The Primary Health Care Research Unit, Region Zealand, Zealand, Denmark., Bissenbakker K; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark., Martiny F; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.; Department of Social Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark., Davidsen A; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark., Kjellberg PK; VIVE - The Danish Center for Social Science Research, Copenhagen, Denmark., Doherty K; Copenhagen Center for Health Technology (CACHET), Department of Health Technology, Technical University of Denmark, Lyngby, Denmark., Mercer SW; Old Medical School, Usher Institute, University of Edinburgh, Edinburgh, UK., Nielsen MH; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark., Reventlow S; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark., Møller A; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark., Rozing M; Department of Public Health, The Section of General Practice and the Research Unit for General Practice, University of Copenhagen, Copenhagen, Denmark.; Psychiatric Center Copenhagen, Copenhagen, Denmark.
Jazyk: angličtina
Zdroj: BMC primary care [BMC Prim Care] 2023 Sep 16; Vol. 24 (1), pp. 188. Date of Electronic Publication: 2023 Sep 16.
DOI: 10.1186/s12875-023-02141-2
Abstrakt: Objective: To evaluate the feasibility and fidelity of implementing and assessing the SOFIA coordinated care program aimed at lowering mortality and increasing quality of life in patients with severe mental illness by improving somatic health care in general practice.
Design: A cluster-randomised, non-blinded controlled pilot trial.
Setting: General Practice in Denmark.
Intervention: The SOFIA coordinated care program comprised extended structured consultations carried out by the GP, group-based training of GPs and staff, and a handbook with information on signposting patients to relevant municipal, health, and social initiatives.
Patients: Persons aged 18 years or older with a diagnosis of psychotic, bipolar, or severe depressive disorder.
Main Outcome Measures: We collected quantitative data on the delivery, recruitment and retention rates of practices and patients, and response rates of questionnaires MMQ and EQ-5D-5 L.
Results: From November 2020 to March 2021, nine practices were enrolled and assigned in a 2:1 ratio to the intervention group (n = 6) or control group (n = 3). Intervention group practices included 64 patients and Control practices included 23. The extended consultations were delivered with a high level of fidelity in the general practices; however, thresholds for collecting outcome measures, and recruitment of practices and patients were not reached.
Conclusion: Our findings suggest that delivering the coordinated care program in a fully powered trial in primary care is likely feasible. However, the recruitment methodology requires improvement to ensure sufficient recruitment and minimize selective inclusion.
Trial Registration: The date of pilot trial protocol registration was 05/11/2020, and the registration number is NCT04618250.
(© 2023. BioMed Central Ltd., part of Springer Nature.)
Databáze: MEDLINE
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