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People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability.
The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period.
If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coordinated, co-produced health care | Experimental |
| |
| Care as usual | No Intervention | Care as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOFIA model | Other | A mandatory two day course for general practitioners assigned to the intervention group A prolonged consultation at the general practitioner Use of an individual care plan |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the design in terms of recruitment of practices and patients | Proportion of contacted general practices, which agree to participate in the study and the eligibility and consent rate of patients. | 6 months after randomization |
| Acceptability of the intervention for patients and general practitioners, staff and patients. | Qualitative semi-structured interviews with patients and general practitioners, staff and patients. | Entire study period (6 months) |
| Retention of patients during the study | Proportion of recruited patients in the intervention group who attend the first consultation. | 6 months after randomization |
| Acceptability of REDcap software for general practitioners | Qualitative semi-structured interviews with general practitioners. | Entire study period (6 months) |
| Effectiveness of the collecting Multimorbidity Questionnaires | Proportion of returned and completed Multimorbidity Questionnaires. | 6 months after randomization |
| Effectiveness of the collecting EQ5D-5L questionnaires | Proportion of returned and completed EQ5D-5L questionnaire. | 6 months after randomization |
| Mortality | Number of all-cause deaths of participants during the 6 month trial period. |
| Measure | Description | Time Frame |
|---|---|---|
| Multimorbidity Questionnaires (MMQ) scores | Scores on Multimorbidity Questionnaire | 3 times during study period (at baseline, before prolonged consultation and 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Reventlow | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Copenhagen | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37908003 | Derived | Tranberg K, Due TD, Rozing M, Jonsson ABR, Kousgaard MB, Moller A. Challenges in reaching patients with severe mental illness for trials in general practice-a convergent mixed methods study based on the SOFIA pilot trial. Pilot Feasibility Stud. 2023 Oct 31;9(1):182. doi: 10.1186/s40814-023-01395-y. | |
| 37715123 | Derived |
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Participants' study information will not be released outside of the study without the written permission of the participant.
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001526 | Behavioral Symptoms |
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| 6 months after randomization |
| Hospitalizations | Number of all-cause in- and outpatient hospitalizations of participants during the 6 months trial period. | 6 months after randomization |
| Tranberg K, Jonsson A, Due T, Siersma V, Brodersen JB, Bissenbakker K, Martiny F, Davidsen A, Kjellberg PK, Doherty K, Mercer SW, Nielsen MH, Reventlow S, Moller A, Rozing M; 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. BMC Prim Care. 2023 Sep 16;24(1):188. doi: 10.1186/s12875-023-02141-2. |
| 34479646 | Derived | Rozing MP, Jonsson A, Koster-Rasmussen R, Due TD, Brodersen J, Bissenbakker KH, Siersma V, Mercer SW, Guassora AD, Kjellberg J, Kjellberg PK, Nielsen MH, Christensen I, Bardram JE, Martiny F, Moller A, Reventlow S; SOFIA Study Group. The SOFIA pilot trial: a cluster-randomized trial of coordinated, co-produced care to reduce mortality and improve quality of life in people with severe mental illness in the general practice setting. Pilot Feasibility Stud. 2021 Sep 3;7(1):168. doi: 10.1186/s40814-021-00906-z. |
| D001519 | Behavior |