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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
76
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
University of Copenhagen
Copenhagen, Denmark
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.
Time frame: 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.
Time frame: Entire study period (6 months)
Retention of patients during the study
Proportion of recruited patients in the intervention group who attend the first consultation.
Time frame: 6 months after randomization
Acceptability of REDcap software for general practitioners
Qualitative semi-structured interviews with general practitioners.
Time frame: Entire study period (6 months)
Effectiveness of the collecting Multimorbidity Questionnaires
Proportion of returned and completed Multimorbidity Questionnaires.
Time frame: 6 months after randomization
Effectiveness of the collecting EQ5D-5L questionnaires
Proportion of returned and completed EQ5D-5L questionnaire.
Time frame: 6 months after randomization
Mortality
Number of all-cause deaths of participants during the 6 month trial period.
Time frame: 6 months after randomization
Hospitalizations
Number of all-cause in- and outpatient hospitalizations of participants during the 6 months trial period.
Time frame: 6 months after randomization
Multimorbidity Questionnaires (MMQ) scores
Scores on Multimorbidity Questionnaire
Time frame: 3 times during study period (at baseline, before prolonged consultation and 6 months after randomization
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