Assessing the Implementation and Feasibility of the SMART-MR

Moral Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122910
• Other study ID #: 20210559-01H
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2023
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moral Injury
• Stress Disorders, Post-Traumatic

Intervention

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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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