NCT05122910

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

October 22, 2021

Last Update Submit

January 11, 2023

Conditions

Keywords

Moral DistressMoral ResilienceHealthcare workersCOVID-19

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Change in the Maslach Burnout Inventory-2 item version (MBI-2 item)

    Baseline, 12 weeks follow-up

  • Change in the Perceived Stress Scale-10 item (PSS-10)

    Baseline, 12 weeks follow-up

  • Change in the Generalized Anxiety Disorder 7-item (GAD-7) scale

    Baseline, 12 weeks follow-up

Study Arms (1)

SMART-MR Program

EXPERIMENTAL

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

Interventions

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.

SMART-MR Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • full-time or part-time TOH staff who provide direct patient care, including: attending physicians, nurses, allied health, social workers and spiritual care providers

You may not qualify if:

  • TOH staff members who do not provide direct patient care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCOVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Edward Spilg, MBChB

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 17, 2021

Study Start

July 15, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations