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Abstract Background Patients 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. Methods We 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. Results Our 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. Conclusions In 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 registration The pilot trial protocol was registered on the 5th of November 2020. The registration number is NCT04618250 .

Abstract 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.

Introduction Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.Methods and analysis In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.Ethics and dissemination The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.Trial registration number NCT05676541.

Background Multimorbidity is associated with increased mortality. Certain combinations of diseases are known to be more lethal than others, but the limited knowledge of how the chronology in which diseases develop impacts mortality may impair the development of effective clinical interventions for patients with multimorbidity. Objective To explore if in multimorbidity the chronology of disease onset is associated with mortality. Design: A prospective nationwide cohort study, including 3,986,209 people aged ≥18 years on 1 January 2000, was performed. We included ten diagnosis groups: lung, musculoskeletal, endocrine, mental, cancer, neurological, gastrointestinal, cardiovascular, kidney, and sensory organs. We defined multimorbidity as the presence of at least two diagnoses from two diagnosis groups (out of ten). To determine mortality, logistic regression models were used to calculate odds ratios (OR) and ratio of ORs (RORs). Results For most combinations of multimorbidity, the chronology of disease onset does not change mortality. However, when multimorbidity included mental health diagnoses, mortality was in general higher if the mental health diagnosis appeared first. If multimorbidity included heart and sensory diagnoses, mortality was higher if these developed second. For the majority of multimorbidity combinations, there was excess mortality if multimorbidity was diagnosed simultaneously, rather than consecutively, for example, heart and kidney (3.58 ROR; CI 2.39–5.36), or mental health and musculoskeletal diagnoses (2.38 ROR; CI 1.70–3.32). Conclusions Overall, in multimorbidity, the chronology in which diseases develop is not associated with mortality, with few exceptions. For almost all combinations of multimorbidity, diagnoses act synergistically in relation to mortality if diagnosed simultaneously.