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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.

Authors :
Tranberg, Katrine
Jønsson, Alexandra
Due, Tina
Siersma, Volkert
Brodersen, John Brandt
Bissenbakker, Kristine
Martiny, Frederik
Davidsen, Annette
Kjellberg, Pia Kürstein
Doherty, Kevin
Mercer, Stewart W.
Nielsen, Maria Haahr
Reventlow, Susanne
Møller, Anne
Rozing, Maarten
Source :
BMC Primary Care; 9/16/2023, Vol. 24 Issue 1, p1-11, 11p
Publication Year :
2023

Abstract

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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
27314553
Volume :
24
Issue :
1
Database :
Complementary Index
Journal :
BMC Primary Care
Publication Type :
Academic Journal
Accession number :
171994279
Full Text :
https://doi.org/10.1186/s12875-023-02141-2