About this trial
People with severe mental illness have a substantially increased risk of undiagnosed and insufficiently treated somatic disease. Somatic Screening in the Capital Region Mental Health Service in Denmark (SomaScreen) is a service-level intervention implemented in psychiatric outpatient clinics in the Capital Region of Denmark to improve the detection and follow-up of somatic disease among patients with psychotic and affective disorders.
This study evaluates whether integrating structured somatic screening into mental health services leads to improved identification and management of somatic disease compared with care as usual. Using a quasi-experimental controlled design with a matched cohort, outcomes among patients exposed to the SomaScreen intervention are compared with those of patients receiving usual care in comparable psychiatric outpatient clinics outside the Capital Region.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older.
Referred to FACT or OPUS psychiatric outpatient clinics in the Capital Region of Denmark.
Starting a new outpatient treatment episode in FACT or OPUS.
Diagnosed with psychotic or affective disorders (ICD-10 F20-F39), including those with comorbid substance use disorders (F10-F19).
Disqualifiers
Individuals younger than 18 years.
Patients in geriatric outpatient clinics.
Individuals not in the target diagnosis group (i.e., without psychotic or affective disorders, F20-F39).
Individuals who do not meet the inclusion criteria above.
Trial design
Parallel
Treatments tested in this trial
Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen)
Diagnostic testSomaScreen is a structured somatic health screening program for adults in psychiatric outpatient care (F-ACT and OPUS clinics). Trained somatic nurses and general practitioner consultants systematically assess patients for cardiovascular disease, asthma, chronic obstructive pulmonary disease (COPD), diabetes, and cancer, and may detect other somatic conditions. Patients with identified conditions are referred to their own general practitioner for follow-up and management. The intervention is distinguished from usual care by its systematic, multi-condition screening and structured referral process.
Treatment groups
Trial outcomes
Primary outcomes
Previously Undiagnosed Somatic Illness
Number of newly identified somatic (non-psychiatric) illnesses per patient in the intervention cohort compared with the matched control cohort. Analysis will use negative binomial regression to estimate relative risk of detection.
Management of Somatic Conditions
Change in management of somatic conditions, comparing intervention and control cohorts. Data will be collected from national health registries.
Secondary outcomes
Intended Mechanisms
Quantitative assessment of whether the intended mechanisms of action of the intervention occur. Data collected from intervention records and linked registries.
Screening and Referral Functioning
Qualitative assessment of how the process components operate in practice. Data collected via structured interviews, questionnaires, and process reports.
Healthcare costs
Total healthcare costs in the intervention cohort compared with the matched control cohort. Costs include all registered healthcare services and prescription medicines. Data will be obtained from national health registries, including healthcare utilization and associated costs.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.