Clinical trial NCT01975948: Evaluation of a Mental Health Physician Support Program in Nova Scotia
Official title: Evaluation of a Mental Health Physician Support Program in Nova Scotia: Impact on Patient Outcomes and Stigmatization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Mental Health
Education and Practice Support Program
Depression
Primary Care
Skill-based training
Patient centered outcomes
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 285
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: The aim of this study is to test the program's effectiveness in a primary care setting in reducing stigma among medical personnel, increasing the comfort level of physicians and staff in providing care to those living with mental illness, and in improving client well-being and mental health.

Detailed description: Skill-based approaches are effective in reducing stigma in health professionals.

Overview: The Nova Scotia (NS) Department of Health and Wellness and the Mental Health Commission of Canada launched a demonstration project in NS-Adult Mental Health Practice Support Program. Originating in British Columbia (BC), it uses a novel learning platform which supports primary healthcare providers with treatment and management of mental illness. We hypothesized that enhanced skills in program participants would lead to increased comfort on the part of practitioners, diminished social distance and stigmatization; improved clinical outcomes and a reduction in healthcare costs.

This evaluation has three co-primary objectives:

* To determine whether the Mental Health Practice Support Program (PSP) leads to lower levels of stigma among physicians participating in the program.
* To determine whether participation in the Mental Health PSP leads to lower levels of stigma among medical office assistants (MOAs)
* To determine whether participation of physicians in the Mental Health PSP leads to greater improvement in depressive symptom ratings among patients they are treating for depression, compared to treatment as usual.

Two secondary objectives:

* To determine whether participation in the PSP leads to improved occupational functioning compared to treatment as usual.
* To assess the impact of participation in the Mental Health PSP on healthcare costs.

Four exploratory objectives:

* To assess physicians' confidence and comfort in the management of depression treatment
* To determine whether physician participation int he Mental Health PSP is associated with a reduced frequency of antidepressant prescribing.
* To determine whether the patients of physicians participating in the Mental Health PSP report higher levels of satisfaction with the treatment that they receive.
* To determine whether patients participation in the Mental Health PSP is associated with improved quality of life.

Methods: Seventy seven practices with one hundred and eleven community-based family physicians were recruited. Each practice was assigned a practice number. Each physician within the practice was assigned a unique identifier number. Individual practitioner or practice teams were randomly assigned to intervention or control groups. Randomization was stratified on the total number of physicians per practice, as well as urban or rural setting to ensure equal distribution of practice clusters and urban and rural groups. STATA, version 12 \[College Station, TX, 2012\] to generate the sequence for practice \[cluster\] randomization. Random numbers were generated from a binomial distribution with a probability of success of 0.5. Intervention group participants attended 3 half-day workshops with a "6- week action period" between workshops to practice learnings. Practice support was provided through diagnostic assessment tools, evidence based self-management tools, and on-site practice support coordinator support. A stigma-assessment tool, the Opening Minds Scale for Healthcare Providers (OMS-HC), was administered to both groups at intervention group pre-training, and post-training. Providers comfort and confidence in diagnosing and managing mental illness was also assessed, at comparable times.

Upon completion of the intervention group training, physicians from both groups were asked to identify 3 consecutive evaluable patients. Patients were enrolled and allocated to intervention or control groups as per their associated physician.

Eligibility criteria: Physician sample:

* A valid license to practice in Nova Scotia.
* The provision of informed consent.

Patient sample:

Inclusion Criteria:

* Depression defined by PHQ-9 score of \> 10.
* \> 18 years old.
* Able to read and speak English.
* Sufficiently intact cognitive functioning (physician judgement).
* Free of urgent or emergent medical or psychiatric issues e.g. unstable cardiovascular disease, suicidal ideation.

Exclusion Criteria:

* Not currently under treatment for depression either with an antidepressant medication or psychotherapy.

Primary outcomes:
measure: Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline
timeFrame: Baseline, 1, 2, 3, and 6 months
measure: Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC)
timeFrame: Baseline and at 6 months
Secondary outcomes:
measure: Between Group Changes in Occupational Functioning From Baseline to 6 Months
timeFrame: Baseline, 1, 2, 3, and 6 months
Other outcomes:
measure: Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness
timeFrame: Baseline and 6 months
measure: Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills
timeFrame: Baseline and 6 months
measure: Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills
timeFrame: Baseline and 6 months
measure: Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months
timeFrame: Baseline, 1, 2,3, and 6 months
measure: Between Groups Changes in Quality of Life From Baseline to 6 Months.
timeFrame: Baseline, 1, 2, 3 and 6 months
measure: Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months
timeFrame: 6 months
measure: Between Group Change in Sheehan Disability Scale (SDS)
timeFrame: Baseline, 1, 2, 3, and 6 months
Locations:
city: Halifax
country: Canada
facility: Dalhousie University Department of Psychiatry
state: Nova Scotia
Study officials:
affiliation: Associate Professor Dalhousie University Department of Psychiatry
name: Bianca A Lauria-Horner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, Departments of Community Health Sciences and Psychiatry, Calgary, Alberta
name: Scott Patten, FRCP(C), PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauria-Horner B, Beaulieu T, Knaak S, Weinerman R, Campbell H, Patten S. Controlled trial of the impact of a BC adult mental health practice support program (AMHPSP) on primary health care professionals' management of depression. BMC Fam Pract. 2018 Nov 28;19(1):183. doi: 10.1186/s12875-018-0862-y.