The SOFIA pilot study: assessing feasibility and fidelity of coordinated care to reduce excess mortality and increase quality of life in patients with severe mental illness in a general practice setting; a cluster-randomised pilot trial.

OBJECTIVE: To evaluate the feasibility and fidelity of implementing and assessing the SOFIA coordinated care program aimed at lowering mortality and increasing quality of life in patients with severe mental illness by improving somatic health care in general practice. DESIGN: A cluster-randomised, non-blinded controlled pilot trial. SETTING: General Practice in Denmark. INTERVENTION: The SOFIA coordinated care program comprised extended structured consultations carried out by the GP, group-based training of GPs and staff, and a handbook with information on signposting patients to relevant municipal, health, and social initiatives. PATIENTS: Persons aged 18 years or older with a diagnosis of psychotic, bipolar, or severe depressive disorder. MAIN OUTCOME MEASURES: We collected quantitative data on the delivery, recruitment and retention rates of practices and patients, and response rates of questionnaires MMQ and EQ-5D-5 L. RESULTS: From November 2020 to March 2021, nine practices were enrolled and assigned in a 2:1 ratio to the intervention group (n = 6) or control group (n = 3). Intervention group practices included 64 patients and Control practices included 23. The extended consultations were delivered with a high level of fidelity in the general practices; however, thresholds for collecting outcome measures, and recruitment of practices and patients were not reached. CONCLUSION: Our findings suggest that delivering the coordinated care program in a fully powered trial in primary care is likely feasible. However, the recruitment methodology requires improvement to ensure sufficient recruitment and minimize selective inclusion. TRIAL REGISTRATION: The date of pilot trial protocol registration was 05/11/2020, and the registration number is NCT04618250.

Experiences of barriers to trans-sectoral treatment of patients with severe mental illness. A qualitative study.

BACKGROUND: Patients with severe mental illness (SMI) have shorter life expectancy than people without SMI, mainly due to overmortality from physical diseases. They are treated by professionals in three different health and social care sectors with sparse collaboration between them, hampering coherent treatment. Previous studies have shown difficulties involved in establishing such collaboration. As the preparatory phase of an intervention to improve physical health of people with SMI and increase collaboration across sector borders, we explored different actors' experiences of barriers for collaboration. METHOD: We collected qualitative data from patients, professionals in general practice, psychiatry and social psychiatry involved in the treatment of these patients. Data consisted of notes from meetings and observations, interviews, focus groups and workshops. Analysis was by Interpretative Phenomenological Analysis. RESULTS: The study revealed many obstacles to collaboration and coherent treatment, including the consultation structures in general practice, sectors being subject to different legislation, and incompatible IT systems. Professionals in general practice and social psychiatry felt that they were left with the responsibility for actions taken by hospital psychiatry without opportunity to discuss their concerns with psychiatrists. There were also cultural differences between health care and social psychiatry, expressed in ideology and language. Social psychiatry had an existential approach to recovery, whereas the views of health professionals were linked to symptom control and based on outcomes. Meanwhile, patients were left in limbo between these separate ideologies with no leadership in place to promote dialogue and integrate treatments between the sectors. CONCLUSION: Many obstacles to integrated trans-sectoral treatment of patients with SMI seem related to a lack of an overriding leadership and organizational support to establish collaboration and remove barriers related to legislation and IT. However, professional and ideological barriers also contribute. Psychiatry does not consider general practice to be part of the treatment team although general practitioners are left with responsibility for decisions taken in psychiatry; and different ideologies and treatment principles in psychiatry and municipal social psychiatry hamper the dialogue between them. There is a need to rethink the organization to avoid that the three sectors live autonomous lives with different cultures and lack of collaboration.

A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT).

BACKGROUND: An acquired brain injury (ABI) is a complex injury often followed by a broad range of cognitive, physical, emotional, and behavioral disabilities. Because of these disabilities, vocational rehabilitation (VR) is a challenging task, however, of great importance, since approximately 75% of the patients with ABI are of working age. Thus, standardized clinically effective and cost-effective methodologies regarding VR for patients with ABI are highly needed. Therefore, the aim of this study is to evaluate the effect of an individually targeted manual-based VR for patient with ABI compared to conventional VR (usual care). METHODS: This study is an interventional, two-arm, six-month follow-up, cluster randomized controlled trial involving four municipalities in the Zealand Region and the Capital Region of Denmark. A total of 84 patients with ABI evenly distributed across four municipalities will be included in the study. The patients will randomly be allocated in a 1:1 ratio to the VR intervention provided by a specialized Brain Injury Centre or the conventional VR provided by the municipalities (usual care). The six- to nine-month intervention will consist of individual and group therapies as well as a work placement program including supported employment. Furthermore, the intervention will include a family intervention program followed up by support to one individual family caregiver. The primary outcomes are increased work or study rate at six-month follow-up. Moreover, a budget impact analysis and possibly a cost-utility analysis of the intervention will be performed. DISCUSSION: This study consists of a comprehensive multidiciplinary VR intervention involving several parties such as the municipalities, a specialized rehabilitation team, and patients' own family caregivers. If this intervention is proven successful when compared to the conventional VR, it will provide evidence for a manual-based individualized holistic approach in returning to work after an ABI. Furthermore, the study will contribute with novel knowledge regarding feasibility and clinical effectiveness of the VR intervention relevant to clinicians, researchers, and policymakers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03086031 . Registered on 21 March 2017.