Evaluation of a Mental Health Physician Support Program in Nova Scotia

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975948
• Other study ID #: CDHA-RS/2014-150
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2021
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Mental Health Practice Support Program
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
• Treatment as Usual
Physicians manage patients with depression as usual

Locations

Country	Name	City	State
Canada	Dalhousie University Department of Psychiatry	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness	A modified version of a British Columbia (BC) developed survey, "Practice Support Program Pre-Post Learning Module Questionnaire" was used. Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident.' Mean scores were averaged and can range from one to three, with lower scores indicating higher confidence. Physicians were asked to their level of confidence to: diagnose depression; screen for addictions; screen for other mental health conditions; treat depression; treat other mental health disorders; prescribe medications for mental health conditions; assess patients' problems and strengths; overall confidence in quality of mental health care provided; knowledge/awareness of non-pharmaceutical interventions; knowledge/awareness of regional mental health resources for patients; Cronbach's alpha .84 at pre-test and .87 at post-test	Baseline and 6 months
Other	Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills	A modified version of a British Columbia (BC) developed survey "Practice Support Program Pre-Post Learning Module Questionnaire" was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., PHQ9 & PHQ2, AUDIT, SMME, MOCA, GAF, GAD-7). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha for physicia was .90 at pre-test and .91 at post-test,; 3	Baseline and 6 months
Other	Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills	A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., CBIS manual, electronic hyperlinked mental health algorithm, Bounce Back program DVD, referrals for Bounce Back telephone coaching, ASW and coaching skills, Diagnostic Assessment Interview, Problem List Action Plan, CBIS resource list, CBIS skills handout, Family Physician Guide, and medication algorithm). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha was .98 at pre-test and .98 at post-test	Baseline and 6 months
Other	Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months	The CSI is a 25-item scale to measure the degree or magnitude of client satisfaction with care received. Responses range from 1 to 7. Total raw scores range from 0 to 175, with higher scores representing higher levels of satisfaction. Total scores were averaged reducing the overall score to a 7-point scale. We compared between-group mean differences of CSI 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 CSI 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
Other	Between Groups Changes in Quality of Life From Baseline to 6 Months.	The Medical Outcomes Short Form (SF-36) assesses quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table.We ompared between-group mean differences of SF-36 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 SF-36 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
Other	Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months	We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.	6 months
Other	Between Group Change in Sheehan Disability Scale (SDS)	The SDS is a visual analog scale which asks respondents to rate from 0-10 the extent to which symptoms have disputed: a: work/school work; b) social life/leisure activities; c) family life/home responsibilities. Total scores can range from 0-30, with lower scores indicating less disruption. We ompared between-group mean differences of SDS 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 SDS 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
Primary	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
Primary	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	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