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Evaluation of a Mental Health Physician Support Program in Nova Scotia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Bianca Horner, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Other: Mental Health Practice Support Program Other: Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Mental Health Physician Support Program in Nova Scotia: Impact on Patient Outcomes and Stigmatization
Actual Study Start Date : November 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mental Health PSP: Physicians
Physicians training in Adult Mental Health Practice Support Program
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


Active Comparator: Treatment as Usual: Physicians
Those administering treatment as usual for depression
Other: Treatment as Usual
Physicians manage patients with depression as usual

Experimental: Mental Health PSP: Patients
Those belonging to a physician who has completed the Adult Mental Health Practice Support Program training.
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


Active Comparator: Treatment as Usual: Patients
Those receiving treatment as usual for depression
Other: Treatment as Usual
Physicians manage patients with depression as usual




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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


  2. 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


  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

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975948


Locations
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Canada, Nova Scotia
Dalhousie University Department of Psychiatry
Halifax, Nova Scotia, Canada, B3H2E2
Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bianca Horner, Primary Mental Healthcare Education Leader, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT01975948    
Other Study ID Numbers: CDHA-RS/2014-150
First Posted: November 5, 2013    Key Record Dates
Results First Posted: June 26, 2017
Last Update Posted: October 14, 2021
Last Verified: September 2021
Individual Participant Data (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
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
Keywords provided by Bianca Horner, Nova Scotia Health Authority:
Mental Health
Education and Practice Support Program
Depression
Primary Care
Skill-based training
Patient centered outcomes
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders