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Randomized Controlled Trial
. 2023 Sep 16;24(1):188.
doi: 10.1186/s12875-023-02141-2.

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

Katrine Tranberg  1 , Alexandra Jønsson  2   3   4 , Tina Due  2   5 , Volkert Siersma  2 , John Brandt Brodersen  2   4   6 , Kristine Bissenbakker  2 , Frederik Martiny  2   7 , Annette Davidsen  2 , Pia Kürstein Kjellberg  8 , Kevin Doherty  9 , Stewart W Mercer  10 , Maria Haahr Nielsen  2 , Susanne Reventlow  2 , Anne Møller  2 , Maarten Rozing  2   11 ; SOFIA Study Group
Affiliations
Randomized Controlled Trial

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

Katrine Tranberg et al. BMC Prim Care. .

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.

Keywords: Complex intervention; Coordinated care program; Extended consultations; General practice; Pilot studies; Recruitment strategies; Severe mental illness.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart visualizing the practice recruitment process in the SOFIA pilot study
Fig. 2
Fig. 2
Flowchart visualizing the patient recruitment process in the SOFIA pilot study
See this image and copyright information in PMC

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