TY - JOUR
T1 - The SOFIA pilot study
T2 - 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
AU - SOFIA Study Group
AU - Tranberg, Katrine
AU - Jønsson, Alexandra
AU - Due, Tina
AU - Siersma, Volkert
AU - Brodersen, John Brandt
AU - Bissenbakker, Kristine
AU - Martiny, Frederik
AU - Davidsen, Annette
AU - Kjellberg, Pia Kürstein
AU - Doherty, Kevin
AU - Mercer, Stewart W
AU - Nielsen, Maria Haahr
AU - Reventlow, Susanne
AU - Møller, Anne
AU - Rozing, Maarten
N1 - Funding Information:
The study is supported by the Novo Nordisk Foundation research grant (NNF16OC0022038). This funding body has and will have no role in the design of the study, the collection, analysis, and interpretation of data, nor the writing of the manuscript.
Funding Information:
We thank the general practitioners, general practice staff, patients, their relatives, and scientific collaborators who have contributed through co-design to the development of and participation in the intervention. The authors wish to personally acknowledge Niels de Fine Olivarius for his acquisition of funding and conception of the SOFIA study, Merethe Kristine Andersen (University of Southern Denmark) for her contribution to the design and assistance with the data collection, Per Bækgaard, and Jakob E. Bardram for their fruitful discussions and critical review. Finally, we are grateful to the OPEN (Open Patient Data Explorative Network, Odense University Hospital, Region of Southern Denmark, (https://open.rsyd.dk/) for their assistance in collecting the data by providing access to REDCap.
Publisher Copyright:
© 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/9/16
Y1 - 2023/9/16
N2 - 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.
AB - 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.
KW - Humans
KW - Pilot Projects
KW - Quality of Life
KW - Feasibility Studies
KW - General Practice
KW - Mental Disorders/therapy
U2 - 10.1186/s12875-023-02141-2
DO - 10.1186/s12875-023-02141-2
M3 - Article
C2 - 37715123
VL - 24
JO - BMC Primary Care
JF - BMC Primary Care
M1 - 188
ER -