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

NCT07518446 | Recruiting

• 2 other identifiers: p-2024-157872023-1305
• Study Type: interventional
• Target: 2,800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Asthma (Diagnosis); Chronic Obstructive Pulmonary Disease (COPD); Diabetes; Cancer; Atrial Fibrillation (AF); Psychiatric Patients, Serious Medical Illness

Keywords

Somatic screening; Early diagnosis; Continuity of patient care; Cohort studies; Mental disorders; Health status disparities

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Intended Mechanisms

  2 years from start of intervention

• Screening and Referral Functioning

  2 years from start of intervention

• Healthcare costs

  2 years from start of intervention

Study Arms (2)

SomaScreen Intervention Cohort

EXPERIMENTAL

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)

Matched Control Cohort (Care as Usual)

NO INTERVENTION

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.

Interventions

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

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.

SomaScreen Intervention Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amager Hospital: lead

Study Sites (1)

Amager Hospital

Copenhagen, 2300, Denmark

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Asthma; Disease; Pulmonary Disease, Chronic Obstructive; Diabetes Mellitus; Neoplasms; Mental Disorders

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lene F Eplov, MD, PhD, Associate Professor

  Amager Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lene F Eplov, MD, PhD, Associate Professor

CONTACT

+4520184687; Lene.Falgaard.Eplov@regionh.dk

Ziggi I Santini, PhD

CONTACT

+4524257369; ziggi.santini@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Associate Professor

Model Details: This study uses a parallel design in which patients receiving the SomaScreen intervention form one cohort, and a matched control cohort is constructed from patients in comparable urban psychiatric outpatient clinics outside the Capital Region. Allocation to the intervention cohort is determined by attendance at outpatient clinics where SomaScreen is implemented, while control cohort participants from similar urban settings are matched with intervention participants at the cluster level. Both cohorts are followed concurrently for up to two years.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: April 8, 2026
• Study Start: September 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): October 30, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)