Abstract
BackgroundPeople with severe mental illness (SMI) have an increased risk of premature mortality, predominantly due to somatic health conditions. Evidence indicates that primary and tertiary 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 of a coordinated co-produced care program (SOFIA model, a Danish acronym for Severe Mental Illness and Physical Health in General Practice) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness.MethodsThe SOFIA pilot trial is designed as a cluster randomized controlled trial targeting general practices in two regions in Denmark. We aim to include 12 practices, each of which is instructed to recruit up to 15 community-dwelling patients aged 18 and older with SMI. Practices will be randomized by a computer in a ratio of 2:1 to deliver a coordinated care program or usual care during a 6-month study period. A randomized algorithm is used to perform randomization. The coordinated care program includes educational training of general practitioners and their clinical staff educational training of general practitioners and their clinical staff, which covers clinical and diagnostic management and focus on patient-centered care of this patient group, after which general practitioners will provide a prolonged consultation focusing on individual needs and preferences of the patient with SMI and a follow-up plan if indicated. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Assessments of the outcome parameters will be administered at baseline, throughout, and at end of the study period.DiscussionIf necessary the intervention will be revised based on results from this study. If delivery of the intervention, either in its current form or after revision, is considered 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. Successful implementation of the intervention would imply preliminary promise for addressing health inequities in patients with SMI.Trial registrationThe trial was registered in Clinical Trials as of November 5, 2020, with registration number NCT04618250.Protocol version: January 22, 2021; original version
Highlights
People with severe mental illness (SMI) have an increased risk of premature mortality, predominantly due to somatic health conditions
If delivery of the intervention, either in its current form or after revision, is considered 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
Preliminary evidence suggests that the mortality gap for people with SMI is amenable to intervention and that primary care may play a pivotal role in reducing this gap [16]
Summary
People with severe mental illness (SMI) have an increased risk of premature mortality, predominantly due to somatic health conditions. Evidence indicates that primary and tertiary prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. I.e., suicide, accidents, and homicide, considerably contribute to this disparity [3], yet chronic somatic health conditions account for the majority of lost life years among people with SMI [4]. Contributing to the higher risk of somatic conditions in SMI patients are unhealthy living conditions, the adverse metabolic effects of long-term psychotropic medication use, and possibly shared genetic and metabolic vulnerability [14, 15]. Preliminary evidence suggests that the mortality gap for people with SMI is amenable to intervention and that primary care may play a pivotal role in reducing this gap [16]
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