Clinical trial NCT04618250: Improving Physical Health in Patients With Psychiatric Disorders in General Practice (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Disorder
Schizophrenia
Bipolar Disorder
Severe Depression
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of the design in terms of recruitment of practices and patients
timeFrame: 6 months after randomization
measure: Acceptability of the intervention for patients and general practitioners, staff and patients.
timeFrame: Entire study period (6 months)
measure: Retention of patients during the study
timeFrame: 6 months after randomization
measure: Acceptability of REDcap software for general practitioners
timeFrame: Entire study period (6 months)
measure: Effectiveness of the collecting Multimorbidity Questionnaires
timeFrame: 6 months after randomization
measure: Effectiveness of the collecting EQ5D-5L questionnaires
timeFrame: 6 months after randomization
measure: Mortality
timeFrame: 6 months after randomization
measure: Hospitalizations
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Multimorbidity Questionnaires (MMQ) scores
timeFrame: 3 times during study period (at baseline, before prolonged consultation and 6 months after randomization
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Susanne Reventlow
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.