Evaluation of a Mental Health Physician Support Program in Nova Scotia

• ClinicalTrials.gov Identifier: NCT01975948
• Recruitment Status: Completed
• First Posted: November 5, 2013
• Results First Posted: June 26, 2017
• Last Update Posted: October 14, 2021
• Sponsor: Nova Scotia Health Authority
• Information provided by (Responsible Party): Bianca Horner, Nova Scotia Health Authority

Tracking Information

• First Submitted Date: October 21, 2013
• First Posted Date: November 5, 2013
• Results First Submitted Date: February 1, 2017
• Results First Posted Date: June 26, 2017
• Last Update Posted Date: October 14, 2021
• Actual Study Start Date: November 2013
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2017)

• Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline [ Time Frame: Baseline, 1, 2, 3, and 6 months ]
  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.
• Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC) [ Time Frame: Baseline and at 6 months ]
  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.

Original Primary Outcome Measures (submitted: October 29, 2013)

• Change from Baseline to study end-point of the Patient Health Questionnaire-9(PHQ-9)score in patients [ Time Frame: baseline, 2, 3, and 6 months ]

The PHQ-9, developed by Drs. Robert L. Spitzer, Janet B.W. Williams specifically for primary care settings is a self-report instrument which takes only a few minutes to complete. The tool is highly sensitive and specific for the diagnosis of depression, and covers the nine symptom-based DSM-IV (Diagnostic and Statistical Manual) and DSM-5 criteria for major depression. It can also produce dimensional symptom severity ratings. The scale covers a two week time frame, essentially covering current rather than past episodes. The PHQ-9 has been extensively validated and is widely used in primary care as a screening instrument and for monitoring treatment outcomes. A PHQ-9 score >10 has a sensitivity for major depression of 88%, and a specificity of 88%, and a positive likelihood ratio of 7.1.

Current Secondary Outcome Measures (submitted: September 20, 2021)

Between Group Changes in Occupational Functioning From Baseline to 6 Months [ Time Frame: Baseline, 1, 2, 3, and 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.

Original Secondary Outcome Measures (submitted: October 29, 2013)

Lam's Employment Absence and Productivity Scale (LEAPS) [ Time Frame: Baseline, 2,3, and 6 months ]

As a measure of occupational functioning, Lam's Employment Absence and Productivity Scale (LEAPS) will be used . This scale was developed in Canada to assess the workplace impact of major depression. LEAPS displayed excellent internal consistency as assessed by Cronbach's alpha: 0.89. During scale development, validity was assessed by comparing the LEAPS to the other clinical and work functioning scales, where it showed excellent concordant validity.

Current Other Pre-specified Outcome Measures (submitted: June 18, 2017)

• Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness [ Time Frame: Baseline and 6 months ]
  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
• Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills [ Time Frame: Baseline and 6 months ]
  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
• Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills [ Time Frame: Baseline and 6 months ]
  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
• Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months [ Time Frame: Baseline, 1, 2,3, and 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.
• Between Groups Changes in Quality of Life From Baseline to 6 Months. [ Time Frame: Baseline, 1, 2, 3 and 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.
• Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months [ Time Frame: 6 months ]
  We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.
• Between Group Change in Sheehan Disability Scale (SDS) [ Time Frame: Baseline, 1, 2, 3, and 6 months ]
  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.

Original Other Pre-specified Outcome Measures (submitted: October 29, 2013)

Health Care Costs Comparison [ Time Frame: Baseline and at 6 months ]

For the purposes of quantifying economic impacts, the Client Service Receipt Inventory will be used . This is a well-used and extensively validated inventory.

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Major Depressive Disorder

Intervention

• Other: Mental Health Practice Support Program

  1. 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

• Other: Treatment as Usual
  Physicians manage patients with depression as usual

Study Arms

• Experimental: Mental Health PSP: Physicians
  Physicians training in Adult Mental Health Practice Support Program
  Intervention: Other: Mental Health Practice Support Program
• Active Comparator: Treatment as Usual: Physicians
  Those administering treatment as usual for depression
  Intervention: Other: Treatment as Usual
• Experimental: Mental Health PSP: Patients
  Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
  Intervention: Other: Mental Health Practice Support Program
• Active Comparator: Treatment as Usual: Patients
  Those receiving treatment as usual for depression
  Intervention: Other: Treatment as Usual

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2016): 285
• Original Estimated Enrollment (submitted: October 29, 2013): 200
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01975948
• Other Study ID Numbers: CDHA-RS/2014-150
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Results will be distributed through publications in academic journals and presented at upcoming conferences, study sponsors and contributors: i.e. the Mental Health Commission of Canada, the Nova Scotia Department of Health and Wellness, Dalhousie University, the University of Calgary, Doctors of Nova Scotia, study participants, etc.

Study Protocol, SAP, and Informed Consent will be shared. However when SAP is checked below in IPD sharing field, it will not allow to be saved (check-mark in SAP does not remain when save button is clicked).

De-identified patient data will not be shared as we made a commitment to physicians that only the PI would have access to this information, even though de-identified, some were concerned that patients could still be identified.

• Supporting Materials: Study Protocol
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Available as of August 21/2017 till December 31/2017
• Access Criteria: Contact: Bianca Lauria-Horner hornerb@dal.ca

• Current Responsible Party: Bianca Horner, Nova Scotia Health Authority
• Original Responsible Party: Nova Scotia Health Authority
• Current Study Sponsor: Nova Scotia Health Authority
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bianca A Lauria-Horner, MD; Associate Professor Dalhousie University Department of Psychiatry
• Principal Investigator: Scott Patten, FRCP(C), PhD; Professor, Departments of Community Health Sciences and Psychiatry, Calgary, Alberta

• PRS Account: Nova Scotia Health Authority
• Verification Date: September 2021