Assessing the Implementation and Feasibility of the SMART-MR

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

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).

Study Overview

• Status: Completed
• Conditions: Moral Injury
• Intervention / Treatment: Behavioral: Stress Management and Resilience Training - Moral Resilience (SMART-MR) program

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SMART-MR Program; Participants will participate in the Stress Management and Resilience Training - Moral Resilience (SMART-MR) program.

Behavioral: Stress Management and Resilience Training - Moral Resilience (SMART-MR) program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12 weeks follow-up
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.	Baseline, 12 weeks follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12 weeks follow-up
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.	Baseline, 12 weeks follow-up
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.	Baseline, 12 weeks follow-up

Collaborators and Investigators

• Sponsor: University of Ottawa
• Investigators: Principal Investigator: Edward Spilg, MBChB, University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Healthcare workers; Moral Distress; Moral Resilience
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 20210559-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No