Assessing the Implementation and Feasibility of the SMART-MR
Primary Purpose
Moral Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stress Management and Resilience Training - Moral Resilience (SMART-MR) program
Sponsored by
About this trial
This is an interventional other trial for Moral Injury focused on measuring Moral Distress, Moral Resilience, Healthcare workers, COVID-19
Eligibility Criteria
Inclusion Criteria:
• full-time or part-time TOH staff who provide direct patient care, including: attending physicians, nurses, allied health, social workers and spiritual care providers
Exclusion Criteria:
• TOH staff members who do not provide direct patient care
Sites / Locations
- The Ottawa Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SMART-MR Program
Arm Description
Participants will participate in the Stress Management and Resilience Training - Moral Resilience (SMART-MR) program.
Outcomes
Primary Outcome Measures
Change in the Measure of Moral Distress-Health Professionals (MMD-HP)
27-item scale that measures healthcare professionals' current levels of moral distress. Respondents rate each item on two Likert scales to indicate: how often a situation occurs during their practice (frequency: 0 = never, 4= very frequent) and how distressing it is when it occurs (distressing: 0= none, 4= very distressing). The frequency score (f) is multiplied by the distress score (d) to receive a composite score ("fxd", range 0-16). These scores are summed to create the overall MMD-HP score (ranging from 0-432), with higher scores indicative of higher moral distress.
Change in the Rushton Moral Resilience Scale (RMRS)
17-item scale assessing moral resilience in healthcare workers. Respondents rate their level of agreement with each item on a Likert scale from 1 ("disagree") to 4 ("agree"). The items form 4 factors: 1) response to moral adversity; 2) personal integrity; 3) relational integrity; and 4) moral efficacy and a total summative score is calculated.
Secondary Outcome Measures
Change in the Maslach Burnout Inventory-2 item version (MBI-2 item)
2 items that capture the emotional exhaustion (i.e., "I feel burned out from my work") and depersonalization (i.e., "I have become more callous toward people since I started this job") domains of burnout. Respondents rate their level of agreement with these items on a scale from 0 (never) to 6 (everyday). A score of >3 on either item is considered indicative of burnout.
Change in the Perceived Stress Scale-10 item (PSS-10)
10-item scale that provides a global measure of perceived stress. Responses range on a 5-point scale from "never" to "very often." A higher score indicates greater stress.
Change in the Generalized Anxiety Disorder 7-item (GAD-7) scale
7-item questionnaire that assessed generalized anxiety. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Cut-off scores of 5, 10, and 15 delineate mild, moderate, and severe anxiety, respectively; scores ≤4 correspond to minimal anxiety.
Full Information
NCT ID
NCT05122910
First Posted
October 22, 2021
Last Updated
January 11, 2023
Sponsor
University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT05122910
Brief Title
Assessing the Implementation and Feasibility of the SMART-MR
Official Title
Assessing the Implementation and Feasibility of the Stress Management and Resilience Training - Moral Resilience Program (SMART-MR) With Frontline Clinical Staff at The Ottawa Hospital: A Non-randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the proposed pilot study is to assess the feasibility and implementation of the SMART-MR program, an integration of stress management, general resilience, and moral resilience skills, with frontline staff who provide direct patient care at The Ottawa Hospital (TOH).
Detailed Description
Many of the sources of stress facing healthcare workers during the COVID-19 pandemic involve difficult ethical trade-offs that give rise to moral distress. Moral distress has personal consequences for healthcare workers, notably for their mental health, and wider consequences for the organization and health system as a whole as it negatively affects quality of care, patient satisfaction, and the recruitment, retention and satisfaction of staff. Moral resilience refers to the capacity of an individual to sustain or restore their integrity in response to moral adversity and has been raised as a potential way to mitigate moral distress.
The Stress Management and Resilience Training (SMART) program is one of the few evidence-based interventions designed to build resilience in healthcare workers. The SMART program is a brief, neuroscience-based intervention, typically delivered in a single 90-minute session. The structured program teaches self-care skills by developing intentional attention and the ability to reframe potentially stressful situations more quickly.
Recently, a modified version of the existing SMART program, SMART-Moral Resilience (SMART-MR), has been developed with an additional focus on reducing moral distress and building moral resilience for healthcare workers. The synergy of general resilience strategies with focus on the moral/ethical dimensions of clinical practice offer clinicians specific skills to address ethical challenges. We believe implementing the SMART-MR program with frontline staff during the COVID-19 pandemic is warranted. Therefore, we plan to pilot this innovative intervention at TOH to assess its feasibility and implementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moral Injury
Keywords
Moral Distress, Moral Resilience, Healthcare workers, COVID-19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMART-MR Program
Arm Type
Experimental
Arm Description
Participants will participate in the Stress Management and Resilience Training - Moral Resilience (SMART-MR) program.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management and Resilience Training - Moral Resilience (SMART-MR) program
Intervention Description
All participants will attend an initial 2.5 hour workshop and a 1-hour follow-up workshop. The workshop will include general resilience strategies with a focus on the moral/ethical dimensions of clinical practice to offer participants specific skills to address ethical challenges. In addition to the workshops, there will be follow-up supplemental resources.
Primary Outcome Measure Information:
Title
Change in the Measure of Moral Distress-Health Professionals (MMD-HP)
Description
27-item scale that measures healthcare professionals' current levels of moral distress. Respondents rate each item on two Likert scales to indicate: how often a situation occurs during their practice (frequency: 0 = never, 4= very frequent) and how distressing it is when it occurs (distressing: 0= none, 4= very distressing). The frequency score (f) is multiplied by the distress score (d) to receive a composite score ("fxd", range 0-16). These scores are summed to create the overall MMD-HP score (ranging from 0-432), with higher scores indicative of higher moral distress.
Time Frame
Baseline, 12 weeks follow-up
Title
Change in the Rushton Moral Resilience Scale (RMRS)
Description
17-item scale assessing moral resilience in healthcare workers. Respondents rate their level of agreement with each item on a Likert scale from 1 ("disagree") to 4 ("agree"). The items form 4 factors: 1) response to moral adversity; 2) personal integrity; 3) relational integrity; and 4) moral efficacy and a total summative score is calculated.
Time Frame
Baseline, 12 weeks follow-up
Secondary Outcome Measure Information:
Title
Change in the Maslach Burnout Inventory-2 item version (MBI-2 item)
Description
2 items that capture the emotional exhaustion (i.e., "I feel burned out from my work") and depersonalization (i.e., "I have become more callous toward people since I started this job") domains of burnout. Respondents rate their level of agreement with these items on a scale from 0 (never) to 6 (everyday). A score of >3 on either item is considered indicative of burnout.
Time Frame
Baseline, 12 weeks follow-up
Title
Change in the Perceived Stress Scale-10 item (PSS-10)
Description
10-item scale that provides a global measure of perceived stress. Responses range on a 5-point scale from "never" to "very often." A higher score indicates greater stress.
Time Frame
Baseline, 12 weeks follow-up
Title
Change in the Generalized Anxiety Disorder 7-item (GAD-7) scale
Description
7-item questionnaire that assessed generalized anxiety. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Cut-off scores of 5, 10, and 15 delineate mild, moderate, and severe anxiety, respectively; scores ≤4 correspond to minimal anxiety.
Time Frame
Baseline, 12 weeks follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• full-time or part-time TOH staff who provide direct patient care, including: attending physicians, nurses, allied health, social workers and spiritual care providers
Exclusion Criteria:
• TOH staff members who do not provide direct patient care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Spilg, MBChB
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessing the Implementation and Feasibility of the SMART-MR
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