Quality-of-life and self-perceived inequity in people with severe mental illness: the SOFIA pilot study

Background Living with severe mental illness (SMI) adversely affects quality of life (QoL). The SOFIA program, a coordinated general practice care initiative in Denmark, aimed to improve QoL and reduce mortality through extended general practitioner (GP) consultations, training for GPs and staff, and support in connecting patients with relevant health and social services.Objective To evaluate the impact of the SOFIA intervention on needs-based QoL, self-perceived inequity, and health-related QoL in people with SMI.Design and Setting Cluster-randomised, non-blinded controlled pilot trial conducted in nine Danish general practices between November 2020 and March 2021. Practices were allocated to a coordinated care program (CCP; n = 27), CCP plus a needs-based QoL tool (CCP+; n = 37), or usual care (control; n = 23).Subjects Adults with psychotic disorders, bipolar disorder, or severe depressive disorder.Main Outcome Measures Outcomes were assessed using the Multi-Morbidity Questionnaire (MMQ) and the EQ-5D-5L.Results No statistically significant differences were observed between intervention and control groups in changes in needs-based QoL. Compared with the control group, the CCP+ group showed statistically significant improvements in two self-perceived inequity domains: not being seen and heard and powerlessness. No significant differences were found for the remaining inequity domains or health-related QoL.Conclusion The findings suggest that comprehensive, coordinated GP consultations may help reduce feelings of inequity among people with SMI. Larger pragmatic randomised controlled trials with adequate power and longer follow-up are needed to determine the intervention’s effectiveness on patient-reported outcomes and long-term health.Trial registration The pilot trial protocol registration was dated 05/11/2020, and the registration number is NCT04618250.