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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Disorder; Psychiatric Disorder; Severe Depression
• Intervention / Treatment: Other: SOFIA model

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Coordinated, co-produced health care	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
NO_INTERVENTION: Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
Retention of patients during the study	Proportion of recruited patients in the intervention group who attend the first consultation.	6 months after randomization
Acceptability of REDcap software for general practitioners	Qualitative semi-structured interviews with general practitioners.	Entire study period (6 months)
Effectiveness of the collecting Multimorbidity Questionnaires	Proportion of returned and completed Multimorbidity Questionnaires.	6 months after randomization
Effectiveness of the collecting EQ5D-5L questionnaires	Proportion of returned and completed EQ5D-5L questionnaire.	6 months after randomization
Mortality	Number of all-cause deaths of participants during the 6 month trial period.	6 months after randomization
Hospitalizations	Number of all-cause in- and outpatient hospitalizations of participants during the 6 months trial period.	6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multimorbidity Questionnaires (MMQ) scores	Scores on Multimorbidity Questionnaire	3 times during study period (at baseline, before prolonged consultation and 6 months after randomization

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Susanne Reventlow, University of Copenhagen

Publications and helpful links

General Publications

• Rozing MP, Jonsson A, Koster-Rasmussen R, Due TD, Brodersen J, Bissenbakker KH, Siersma V, Mercer SW, Guassora AD, Kjellberg J, Kjellberg PK, Nielsen MH, Christensen I, Bardram JE, Martiny F, Moller A, Reventlow S; SOFIA Study Group. The SOFIA pilot trial: a cluster-randomized trial of coordinated, co-produced care to reduce mortality and improve quality of life in people with severe mental illness in the general practice setting. Pilot Feasibility Stud. 2021 Sep 3;7(1):168. doi: 10.1186/s40814-021-00906-z.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 6, 2020
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Problem Behavior; Mental Disorders; Bipolar Disorder
• Other Study ID Numbers: NNF16OC0022038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants' study information will not be released outside of the study without the written permission of the participant.

Drug and device information, study documents

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