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Completed

NCT Number: NCT04618250

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

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.

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Key information

Conditions

Psychiatric Disorder Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Severe Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Effectiveness of the design in terms of recruitment of practices and patients

    Time frame: 6 months after randomization

    Proportion of contacted general practices, which agree to participate in the study and the eligibility and consent rate of patients.

  2. Acceptability of the intervention for patients and general practitioners, staff and patients.

    Time frame: Entire study period (6 months)

    Qualitative semi-structured interviews with patients and general practitioners, staff and patients.

  3. Retention of patients during the study

    Time frame: 6 months after randomization

    Proportion of recruited patients in the intervention group who attend the first consultation.

  4. Acceptability of REDcap software for general practitioners

    Time frame: Entire study period (6 months)

    Qualitative semi-structured interviews with general practitioners.

  5. Effectiveness of the collecting Multimorbidity Questionnaires

    Time frame: 6 months after randomization

    Proportion of returned and completed Multimorbidity Questionnaires.

  6. Effectiveness of the collecting EQ5D-5L questionnaires

    Time frame: 6 months after randomization

    Proportion of returned and completed EQ5D-5L questionnaire.

  7. Mortality

    Time frame: 6 months after randomization

    Number of all-cause deaths of participants during the 6 month trial period.

  8. Hospitalizations

    Time frame: 6 months after randomization

    Number of all-cause in- and outpatient hospitalizations of participants during the 6 months trial period.

Secondary outcomes

  1. Multimorbidity Questionnaires (MMQ) scores

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

    Scores on Multimorbidity Questionnaire

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study 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

Acronym: SOFIA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2020
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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