Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen) (SomaScreen)

Somatic Screening in the Capital Region Mental Health Service in Denmark (SomaScreen) - Study Protocol for a Quasi-experimental Controlled Intervention Study With a Matched Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Diabetes; Cancer; Chronic Obstructive Pulmonary Disease (COPD); Atrial Fibrillation (AF); Psychiatric Patients, Serious Medical Illness; Asthma (Diagnosis)
• Intervention / Treatment: Diagnostic test: Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen)

Detailed Description

Background and Rationale

Individuals with severe mental illness experience pronounced health inequalities, including a markedly elevated risk of somatic disease and premature mortality. A substantial proportion of this excess mortality is attributable to common physical conditions such as cardiovascular disease, respiratory disease, diabetes, and cancer. These conditions are often underdiagnosed or insufficiently managed in this population due to complex interactions between illness-related factors, treatment side effects, socioeconomic vulnerability, and barriers in accessing somatic health care.

In Denmark, most diagnosis and treatment of somatic disease occurs in general practice, either directly or through referral to secondary care. However, patients with severe mental illness may face difficulties engaging with general practice, and coordination across sectors remains challenging. Strengthening somatic disease detection and care pathways within psychiatric services may therefore represent an important opportunity to reduce health inequalities.

The SomaScreen Intervention

Somatic Screening in the Capital Region Mental Health Service in Denmark (SomaScreen) was implemented in psychiatric outpatient clinics in the Capital Region of Denmark as a service-level initiative to improve early detection and management of somatic disease. The intervention integrates structured somatic screening into psychiatric outpatient care and actively supports transitions to general practice.

Somatic examinations are conducted by specially trained somatic nurses and general practitioner consultants embedded within psychiatric outpatient clinics. A standardized consultation model is used, incorporating systematic preparation, extended consultation time, and a structured questioning approach tailored to patients with severe mental illness. When somatic disease is suspected or identified, referral to general practice is facilitated, including support with appointment booking and follow-up.

The intervention is delivered within Flexible Assertive Community Treatment (F-ACT) and OPUS outpatient clinics, both of which are multidisciplinary mental health service models for patients with severe mental illness. OPUS primarily serves young adults with early psychosis, whereas F-ACT serves a broader population with severe mental disorders across age groups. Both models emphasize continuity of care, assertive outreach, and treatment within patients' everyday environments.

Recruitment and Inclusion Criteria

Eligible participants are adult patients (18+) referred to F-ACT or OPUS outpatient clinics who are starting a new outpatient treatment episode. Patients must have a primary diagnosis of psychotic or affective disorder (F20-39) and may have comorbid substance use disorders (F10-19). Geriatric outpatient clinics are not included, and patients may be of any adult age. Patients who meet these criteria are systematically offered somatic screening.

Study Design

Because SomaScreen was implemented as a routine service initiative prior to the establishment of a research protocol, the intervention was not designed as a randomized clinical trial. Allocation to the intervention was determined by service delivery, and randomization was not feasible. Patients receiving SomaScreen therefore constitute a cohort defined by exposure to the intervention rather than an experimental arm.

To enable evaluation of intervention effects, the study uses a quasi-experimental controlled design with a matched cohort. Patients exposed to SomaScreen are compared with a control cohort receiving care as usual in comparable psychiatric outpatient clinics located in other major urban regions of Denmark. Matching is conducted to enhance comparability and reduce confounding.

Blinding is not applied in this study, as identification of intervention exposure is required for cohort construction and matching procedures. Participants in both the intervention and control cohorts are followed for up to two years from the start of the outpatient treatment episode, allowing longitudinal assessment of outcomes.

Intervention Cohort Operationalization

There is a single intervention cohort comprising all patients meeting inclusion criteria and starting a new outpatient treatment episode in SomaScreen-implementing FACT/OPUS clinics. Two complementary analysis approaches will be applied to this cohort:

Intention-to-treat analysis (primary): Includes all patients in the intervention cohort, regardless of actual participation in SomaScreen. This approach reflects real-world effectiveness under routine service conditions.

Adherence-stratified analysis (supplementary): Applied to patients captured in intervention-specific data collection (i.e., those who attended at least the initial somatic nurse screening). Patients will be stratified by adherence level to examine dose-response effects, with higher exposure values assigned to those completing additional intervention steps (screening completion, GP appointment booking, and GP consultation attendance).

Evaluation Framework

The evaluation comprises three complementary components: effectiveness, process, and health economic evaluation.

The effectiveness evaluation examines whether exposure to SomaScreen is associated with improved identification and management of somatic disease compared with care as usual. The process evaluation investigates whether the intended mechanisms of action occur in practice, for whom the intervention works best, and how the screening and referral components function within routine clinical settings. The health economic evaluation assesses whether the intervention represents a cost-effective use of health care resources.

Data Sources and Analysis Overview

The study combines intervention-specific data with nationwide Danish register data, linked at the individual level through secure, pseudonymized procedures. Register-based data enable longitudinal follow-up and comprehensive assessment of health care utilization and outcomes across sectors.

Analyses are conducted using appropriate regression-based methods for matched cohort data and clustered observations.

• Study Type: Interventional
• Enrollment (Estimated): 2800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lene F Eplov, MD, PhD, Associate Professor; Phone Number: +4520184687; Email: Lene.Falgaard.Eplov@regionh.dk
• Study Contact Backup: Name: Ziggi I Santini, PhD; Phone Number: +4524257369; Email: ziggi.santini@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2300
    • Recruiting
    • Amager Hospital
    • Contact: Lene F Eplov, MD, PhD, Associate Professor; Phone Number: +4520184687; Email: Lene.Falgaard.Eplov@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SomaScreen Intervention Cohort; Patients in this arm receive the SomaScreen intervention, consisting of systematic somatic screening conducted by trained somatic nurses and general practitioner consultants in psychiatric outpatient clinics (F-ACT and OPUS). The intervention focuses on detecting cardiovascular disease, asthma, chronic obstructive pulmonary disease (COPD), diabetes, and cancer, but may also identify other somatic conditions. Patients with detected conditions are referred to their general practitioner for follow-up or further management. This cohort is distinguished from the control arm by exposure to the structured somatic screening intervention.	Diagnostic test: Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen); SomaScreen 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.
No Intervention: Matched Control Cohort (Care as Usual); Patients in this arm receive standard psychiatric outpatient care at clinics in urban areas outside the Capital Region. They do not receive the SomaScreen somatic screening intervention. Control clinics are matched to intervention clinics at the cluster level using propensity score matching based on clinic-level characteristics, including average age, sex distribution, distribution of socioeconomic status, distribution of psychiatric diagnoses, Charlson Comorbidity Index (CCI), number of patients attached to the clinic, number of employed physicians, and number of employed nurses. These patients continue their usual care, including routine monitoring and management of somatic conditions by their general practitioner or secondary care providers. This cohort is distinguished from the intervention arm by the absence of structured somatic screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years from start of intervention
Management of Somatic Conditions	Change in management of somatic conditions, comparing intervention and control cohorts. Data will be collected from national health registries.	2 years from start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intended Mechanisms	Quantitative assessment of whether the intended mechanisms of action of the intervention occur. Data collected from intervention records and linked registries.	2 years from start of intervention
Screening and Referral Functioning	Qualitative assessment of how the process components operate in practice. Data collected via structured interviews, questionnaires, and process reports.	2 years from start of intervention
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.	2 years from start of intervention

Collaborators and Investigators

• Sponsor: Amager Hospital
• Investigators: Principal Investigator: Lene F Eplov, MD, PhD, Associate Professor, Amager Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mental disorders; Early diagnosis; Continuity of patient care; Cohort studies; Somatic screening; Health status disparities
• Additional Relevant MeSH Terms: Endocrine System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Chronic Disease; Disease Attributes; Metabolic Diseases; Immune System Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Lung Diseases; Glucose Metabolism Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Neoplasms; Heart Failure; Pulmonary Disease, Chronic Obstructive; Asthma; Disease; Mental Disorders; Diabetes Mellitus; Atrial Fibrillation
• Other Study ID Numbers: p-2024-15787; 2023-1305 (Other Grant/Funding Number: The Danish Ministry of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared, in accordance with Danish data protection regulations. Data contain sensitive health information from psychiatric patients and cannot be shared outside the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No