Evaluation of a Mental Health Physician Support Program in Nova Scotia

Study Overview
=================
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.

Official Title
-----------------
Evaluation of a Mental Health Physician Support Program in Nova Scotia: Impact on Patient Outcomes and Stigmatization

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Other: Mental Health Practice Support Program
* Other: Treatment as Usual


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mental Health PSP: Physicians<br>Physicians training in Adult Mental Health Practice Support Program | Other: Mental Health Practice Support Program<br>* training and (2) practice support. Three half day workshop sessions over a 24 week period. Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes<br>|
| Active Comparator: Treatment as Usual: Physicians<br>Those administering treatment as usual for depression | Other: Treatment as Usual<br>* Physicians manage patients with depression as usual<br>|
| Experimental: Mental Health PSP: Patients<br>Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training. | Other: Mental Health Practice Support Program<br>* training and (2) practice support. Three half day workshop sessions over a 24 week period. Practice support: 3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes<br>|
| Active Comparator: Treatment as Usual: Patients<br>Those receiving treatment as usual for depression | Other: Treatment as Usual<br>* Physicians manage patients with depression as usual<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline | The Patient Health Questionnaire-9 (PHQ-9) covers nine symptom-based Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Scores range from 0-27, with higher scores indicating more severe depression severity. We compared between-group mean differences of PHQ-9 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal PHQ-9 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test. | Baseline, 1, 2, 3, and 6 months | 
| Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) | The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures three main dimensions of stigma; negative attitudes, health professionals' own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction. | Baseline and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between Group Changes in Occupational Functioning From Baseline to 6 Months | Lam's Employment Absence and Productivity Scale (LEAPS) is a 7 item scale that assesses workplace impact of major depression. Each item is rated on a 5-point Likert scale with the following response format: none of the time (0%), some of the time (25%), half the time (50%), most of the time (75%), or all the time (100%), scored as 0-4, respectively. Total scores can range from 0-28 with lower scores indicating less disruption.We compared between-group mean differences of LEAPs scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal LEAPs ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test. | Baseline, 1, 2, 3, and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mental Health, Education and Practice Support Program, Depression, Primary Care, Skill-based training, Patient centered outcomes