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

NCT04618250 | Completed

• 1 other identifier: NNF16OC0022038
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorder; Schizophrenia; Bipolar Disorder; Severe Depression

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Multimorbidity Questionnaires (MMQ) scores

  3 times during study period (at baseline, before prolonged consultation and 6 months after randomization

Study Arms (2)

Coordinated, co-produced health care

EXPERIMENTAL

Other: SOFIA model

Care as usual

NO INTERVENTION

Care as usual

Interventions

SOFIA model OTHER

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

Coordinated, co-produced health care

Eligibility Criteria

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

You may qualify if:

• 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)).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, Denmark

Location

Related Publications (3)

• Tranberg K, Due TD, Rozing M, Jonsson ABR, Kousgaard MB, Moller A. Challenges in reaching patients with severe mental illness for trials in general practice-a convergent mixed methods study based on the SOFIA pilot trial. Pilot Feasibility Stud. 2023 Oct 31;9(1):182. doi: 10.1186/s40814-023-01395-y.

  PMID: 37908003 DERIVED

• Tranberg K, Jonsson A, Due T, Siersma V, Brodersen JB, Bissenbakker K, Martiny F, Davidsen A, Kjellberg PK, Doherty K, Mercer SW, Nielsen MH, Reventlow S, Moller A, Rozing M; SOFIA Study Group. The SOFIA pilot study: assessing feasibility and fidelity of coordinated care to reduce excess mortality and increase quality of life in patients with severe mental illness in a general practice setting; a cluster-randomised pilot trial. BMC Prim Care. 2023 Sep 16;24(1):188. doi: 10.1186/s12875-023-02141-2.

  PMID: 37715123 DERIVED

• 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.

  PMID: 34479646 DERIVED

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Susanne Reventlow

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 5, 2020
• Study Start: November 6, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)