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

Research output: Contribution to journal › Journal article › Research › peer-review

Standard

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. / 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; SOFIA Study Group.

In: BMC Primary Care, Vol. 24, No. 1, 188, 2023.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Tranberg, K, Jønsson, A, Due, T, Siersma, V, Brodersen, JB, Bissenbakker, K, Martiny, F, Davidsen, A, Kjellberg, PK, Doherty, K, Mercer, SW, Nielsen, MH, Reventlow, S, Møller, A, Rozing, M & SOFIA Study Group 2023, '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', BMC Primary Care, vol. 24, no. 1, 188. https://doi.org/10.1186/s12875-023-02141-2

APA

Tranberg, K., Jønsson, A., Due, T., Siersma, V., Brodersen, J. B., Bissenbakker, K., Martiny, F., Davidsen, A., Kjellberg, P. K., Doherty, K., Mercer, S. W., Nielsen, M. H., Reventlow, S., Møller, A., Rozing, M., & SOFIA Study Group (2023). 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. BMC Primary Care, 24(1), [188]. https://doi.org/10.1186/s12875-023-02141-2

Vancouver

Tranberg K, Jønsson A, Due T, Siersma V, Brodersen JB, Bissenbakker K et al. 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. BMC Primary Care. 2023;24(1). 188. https://doi.org/10.1186/s12875-023-02141-2

Author

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 ; SOFIA Study Group. / 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. In: BMC Primary Care. 2023 ; Vol. 24, No. 1.

Bibtex

@article{8d7d8ad07d364fa8b30f9a79ea669c5d,
title = "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",
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 = "Humans, Pilot Projects, Quality of Life, Feasibility Studies, General Practice, Mental Disorders/therapy",
author = "Katrine Tranberg and Alexandra J{\o}nsson and Tina Due and Volkert Siersma and Brodersen, {John Brandt} and Kristine Bissenbakker and Frederik Martiny and Annette Davidsen and Kjellberg, {Pia K{\"u}rstein} and Kevin Doherty and Mercer, {Stewart W} and Nielsen, {Maria Haahr} and Susanne Reventlow and Anne M{\o}ller and Maarten Rozing and {SOFIA Study Group}",
note = "{\textcopyright} 2023. BioMed Central Ltd., part of Springer Nature.",
year = "2023",
doi = "10.1186/s12875-023-02141-2",
language = "English",
volume = "24",
journal = "BMC Primary Care",
issn = "2731-4553",
publisher = "BioMed Central Ltd.",
number = "1",

}

RIS

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 - 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

AU - SOFIA Study Group

N1 - © 2023. BioMed Central Ltd., part of Springer Nature.

PY - 2023

Y1 - 2023

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 - Journal article

C2 - 37715123

VL - 24

JO - BMC Primary Care

JF - BMC Primary Care

SN - 2731-4553

IS - 1

M1 - 188

ER -

ID: 368419145