ArticlePilot and feasibility studies2021
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.
Article in Pilot and feasibility studies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04618250 (A Cluster Randomized, Pilot Trial of Coordinated, Co-produced Care to Reduce Excess Mortality and Improve Quality of Life in Patients With Severe Mental Illness in General Practice Setting), which is not on this map. Cited by 11 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Cluster Randomized, Pilot Trial of Coordinated, Co-produced Care to Reduce Excess Mortality and Improve Quality of Life in Patients With Severe Mental Illness in General Practice Setting
Who cites it
11 citing papers in PubMed.
- Quality-of-life and self-perceived inequity in people with severe mental illness: the SOFIA pilot study.Scandinavian journal of primary health care · 2026Trial
- Trial
- Enacted Restoration of Selfhood: A Kierkegaardian Perspective on Self-harm Among People with Mental Illness.Culture, medicine and psychiatry · 2026Article
- Developing a prediction model to identify people with severe mental illness without regular contact to their GP - a study based on data from the Danish national registers.BMC psychiatry · 2024Article
- General practitioners' experiences of providing somatic care for patients with severe mental illness: a qualitative study.BMC primary care · 2024Article
- Article
- Article
- 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 and feasibility studies · 2023Article
- Introducing extended consultations for patients with severe mental illness in general practice: Results from the SOFIA feasibility study.BMC primary care · 2023Article
- Interventions to Promote the Utilization of Physical Health Care for People with Severe Mental Illness: A Scoping Review.International journal of environmental research and public health · 2022Article
- The effect of disease onset chronology on mortality among patients with multimorbidity: A Danish nationwide register study.Journal of multimorbidity and comorbidityArticle
Corrections and comments
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Authors and funding
18 authors.
Funding
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. DISCUSSION: If 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.
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