ArticlePilot and feasibility studies2023
Challenges in reaching patients with severe mental illness for trials in general practice-a convergent mixed methods study based on the SOFIA pilot trial.
Article in Pilot and feasibility studies, 2023. 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 8 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
8 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
- Facilitating access to mental healthcare for patients with long-term conditions in general practice: a qualitative collective case study.Scandinavian journal of primary health care · 2026Article
- Increasing participation of people with thought disorder in clinical research.European psychiatry : the journal of the Association of European Psychiatrists · 2026Review
- Challenges and solutions to participation in mental health clinical trials: Count Me In 2.0.BMJ mental health · 2026Article
- Supporting continuous glucose monitoring for people with serious mental illness and type 2 diabetes: a co-design study for a structured intervention.Frontiers in health services · 2026Article
- (Cost-)effectiveness and implementation of a combined lifestyle intervention for outpatients with severe mental illness (GOAL!): a hybrid quasi-experimental study protocol.BMC psychiatry · 2024Article
- 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
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Authors and funding
6 authors.
Funding
Abstract
backgroundPatients with severe mental illness (SMI) die prematurely due to undetected and inadequate treatment of somatic illnesses. The SOFIA pilot study was initiated to mend this gap in health inequity. However, reaching patients with SMI for intervention research has previously proven difficult. This study aimed to investigate the recruitment of patients with SMI for the SOFIA pilot study in 2021.
methodsWe used a mixed-method convergent design. The qualitative material comprised 20 interviews with general practitioners (GPs) and staff, during patient recruitment. The quantitative data consisted of process data on baseline characteristics, GPs reported reasons for excluding a patient, reported reasons for patients declining participation, and registered data from a Danish population of patients with SMI. We used thematic analysis in the qualitative analysis and descriptive statistics for the quantitative analysis. Pillar integration was used for integrating the material.
resultsOur findings show that selection bias occurred in the pilot study. We describe four main themes based on the integrated analysis that highlights selection issues: (1) poor data quality and inconsistency in defining severity definitions troubled identification and verification, (2) protecting the patient and maintaining practice efficiency, (3) being familiar with the patient was important for a successful recruitment, and (4) in hindsight, the GPs questioned whether the target population was reached.
conclusionsIn the light of theories of professions and street-level bureaucracy, we find that the main drivers of the patient selection bias occurring in the SOFIA pilot study were that 1) GPs and staff mended eligibility criteria to protect certain patients and/or to minimize workload and maintain efficiency in the practice 2) the data from the GP record systems and the digital assessment tool to assist recruitment was not optimal. Interventions targeting this patient group should carefully consider the recruitment strategy with a particular focus on professionals' discretionary practices and information technology pitfalls.
trial registrationThe pilot trial protocol was registered on the 5th of November 2020. The registration number is NCT04618250 .
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