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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

Status: Recruiting

Location: See location...

Intervention Type: Diagnostic test

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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).

Locations

Other Locations

Denmark

Amager Hospital

RECRUITING

Copenhagen

Contact Information

Primary

Lene F Eplov, MD, PhD, Associate Professor

Lene.Falgaard.Eplov@regionh.dk

+4520184687

Backup

Ziggi I Santini, PhD

ziggi.santini@regionh.dk

+4524257369

Time Frame

Start Date: 2024-09-01

Estimated Completion Date: 2028-10-30

Participants

Target number of participants: 2800

Treatments

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.

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.

Related Therapeutic Areas

Chronic Obstructive Pulmonary Disease (COPD)

Heart Failure

Atrial Fibrillation

Asthma

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