Improving Physical Health in Patients With Psychiatric Disorders in General Practice (SOFIA)

Schizophrenia Clinical Trial

— SOFIA  

Official title:

A Cluster Randomized, Pilot Trial of Coordinated, Co-produced Care to Reduce Excess Mortality and Improve Quality of Life in Patients With Severe Mental Illness in General Practice Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04618250
• Other study ID #: NNF16OC0022038
• Status: Completed
• Phase: N/A
• Start date: November 6, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2022
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

People with a severe mental illness (SMI) have an increased risk for premature mortality, predominantly due somatic health conditions. Evidence indicates that prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (SOFIA model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The primary outcomes are description of study feasibility (recruitment and retention) and acceptability.

The SOFIA trial is designed as cluster randomized controlled trial targeting general practices in two regions in Denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (SMI). Practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. An online randomized algorithm is used to perform randomization. The coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with SMI. Assessments are administered at baseline, and at end of study period.

If delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Registered at a general practice situated in the Danish Capital Region or the Region of Zealand;

• Registered at general practice with International Classification of Primary Care version 2 (ICPC-2) diagnostic code p72 (psychotic disorders);

• Registered at general practice with ICPC-2 diagnostic code p73 (bipolar mood disorders);

• Prescription of Lithium (Anatomical Therapeutic Chemical (ATC): N05AN);

• Registered at general practice with ICPC-2 diagnostic code p76 AND (Prescription of Lamotrigine (N03A09) OR Carbamazepine (N03AF01) OR Valproic Acid (N03AG01));

• Registered at general practice with ICPC-2 diagnostic code p76 (unipolar depressive disorders) AND (Prescription of tricyclic antidepressants (N06AA) AND/OR venlafaxine (N06AX16) AND/OR duloxetine (N06AX21) AND/OR Monoamine Oxidase A Inhibitor (MAOi) (N06AG) AND/OR non-selective MAOi (N06AF)).

Exclusion Criteria:

• Subjected to any type of legal measure as stipulated in the Danish Mental Health Law;

• Registered with a dementia diagnosis ICPC-2 p70 (dementia);

• Receiving end-of-life care;

• Non-Danish speakers;

• Assumed by the patient's general practitioner to have an overall functional level that is too low for meaningful participation in trial.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder
• Schizophrenia
• Severe Depression

Intervention

Other:
• SOFIA model
A mandatory two day course for general practitioners assigned to the intervention group A prolonged consultation at the general practitioner Use of an individual care plan

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of the design in terms of recruitment of practices and patients	Proportion of contacted general practices, which agree to participate in the study and the eligibility and consent rate of patients.	6 months after randomization
Primary	Acceptability of the intervention for patients and general practitioners, staff and patients.	Qualitative semi-structured interviews with patients and general practitioners, staff and patients.	Entire study period (6 months)
Primary	Retention of patients during the study	Proportion of recruited patients in the intervention group who attend the first consultation.	6 months after randomization
Primary	Acceptability of REDcap software for general practitioners	Qualitative semi-structured interviews with general practitioners.	Entire study period (6 months)
Primary	Effectiveness of the collecting Multimorbidity Questionnaires	Proportion of returned and completed Multimorbidity Questionnaires.	6 months after randomization
Primary	Effectiveness of the collecting EQ5D-5L questionnaires	Proportion of returned and completed EQ5D-5L questionnaire.	6 months after randomization
Primary	Mortality	Number of all-cause deaths of participants during the 6 month trial period.	6 months after randomization
Primary	Hospitalizations	Number of all-cause in- and outpatient hospitalizations of participants during the 6 months trial period.	6 months after randomization
Secondary	Multimorbidity Questionnaires (MMQ) scores	Scores on Multimorbidity Questionnaire	3 times during study period (at baseline, before prolonged consultation and 6 months after randomization