RCT of Intensive, Brief, and Control Indigenous Cultural Safety Training Interventions for Health Care Providers
Reconciling Relationships - An RCT Examining Relational and Clinical Decision-Making Impacts of Intensive, Brief and Control Indigenous Cultural Safety Training Interventions for Health Care Providers
1 other identifier
interventional
58
1 country
1
Brief Summary
Despite Canada's relative global affluence, striking Indigenous/non-Indigenous health disparities persist. Following the release of the Truth and Reconciliation Commission of Canada's Final Report, and the publication of the First Peoples, Second Class Treatment report, there has been a growing recognition that the Canadian healthcare system - and the healthcare professional (HCP) - Indigenous patient relationship in particular - is a critical, necessary, and promising juncture for intervention. There has been a significant increase in the number of Indigenous cultural safety trainings for HCP across Canada. However, these programs have yet to be systematically evaluated. This study will use a randomized parallel group design to understand and compare the effects of an intensive multi-modular Indigenous cultural safety training program (Arm 1); a brief, 2-hour, computer-based training session plus 2 follow-up emails (Arm 2); and primary care-related training program (Arm 3, control) for staff physicians, nurse practitioners, and resident physicians affiliated at large urban academic teaching hospitals in Toronto, Canada. 60 participants will be recruited and randomized into one of the three study arms. Participants will complete a series of surveys and questionnaires at baseline and 9-11 weeks post-intervention that include measures of explicit and implicit race bias. We predict that the educational intervention in Arm 1 will have the most positive effect, followed by Arm 2 and 3 respectively. We anticipate that the results of this study will help urban hospitals implement Indigenous cultural safety training programs that are beneficial to their staff and ultimately improve the quality of care provided to Indigenous patients across Canada.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2022
CompletedFirst Submitted
Initial submission to the registry
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
June 6, 2023
CompletedJune 6, 2023
June 1, 2023
3.5 years
May 12, 2023
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Whether or not participant would be recommended as a health care provider to family or friends?
Unannounced Standardized patient answers categorical question: "Would you recommend this health care provider to family and friends?" 4 point Likert scale (1. not recommend; 2. recommend with reservations; 3. recommend; 4. highly recommend. Higher score means better outcome
8-10 weeks post-intervention/control
Mean Quality of Health Care Provider Relationship and Communication Scale Score
Unannounced Indigenous Standardized patients will assess their experience of provider engagement, communication, and Indigenous cultural safety skills using the newly developed Quality of Health Care Provider Relationship and Communication Scale. Min value: 1 Max value: 5 Higher score means better outcome.
8-10 weeks post-intervention/control
Mean Adherence to Clinical Standards of Care Scale Score
Unannounced Indigenous Standardized patients will assess adherence of participants to clinical standards of care using developed Adherence to Clinical Standards of Care Scale for NSAID renewal and pain assessment. UISPs to present with acute flare of known ankylosing spondylitis and request NSAID renewal. History of episodic retrosternal chest pain suspicious for NSAID induced gastro-esophageal reflux disease only elicited with a review of the GI side effects of NSAIDS. Min value: 0 Max value: 22 Higher score means better outcome.
8-10 weeks post-intervention/control
Secondary Outcomes (4)
Indigenous Implicit Association Test (IAT) Scores
At baseline and 9-11 weeks post-intervention/control
Modern Prejudice Attitudes Towards Aboriginals Scale (M-PATAS)
At baseline and 9-11 weeks post-intervention/control
Internal Motivation to Respond Without Prejudice Scale (IMS)
At baseline and 9-11 weeks post-intervention/control
External Motivation to Respond Without Prejudice Scale (EMS)
At baseline and 9-11 weeks post-intervention/control
Study Arms (3)
Intensive Intervention ("Big Canoe")
EXPERIMENTAL20 participants will be randomly assigned to Arm 1. Participants in Arm 1 ("the Big Canoe") will complete an intensive, multi-modular Indigenous cultural safety education training program that is offered online and led by trained facilitators. The curriculum in Arm 1 was developed by the San'yas Indigenous Cultural Safety Training Program in British Columbia with the support of the Ontario Indigenous Cultural Safety Training Program.
Brief Intervention ("Little Canoe")
ACTIVE COMPARATOR20 participants will be randomly assigned to Arm 2. Participants in Arm 2 ("the Little Canoe") will complete a brief, 2-hour, interactive, computer-based Indigenous race-bias education session that is offered in a computer lab with a researcher present and followed up with 2 reinforcement/reminder emails that ask questions about strategy usage at 6 and 8 weeks after the session. The intervention in Arm 2 is an Indigenous adaption of the Devine et al. (2012) anti-bias habit-breaking intervention.
Control
OTHER20 participants will be randomly assigned to Arm 3. Participants in Arm 3 (control) will complete a primary care-related training program that is time-attention matched to Arm 1 but does not contain any content on anti-bias, anti-oppression, Indigenous peoples, or any content related to the unannounced Indigenous standardized patient encounter.
Interventions
The Big Canoe will involve an intensive, multi-modular Indigenous cultural safety education training program that is offered online and led by trained facilitators. It is 10 modules long and takes 10 weeks to complete (1 hour of learning per week).
The Little Canoe involves a brief, 2-hour, interactive, computer-based Indigenous race-bias education session that is offered in a computer lab with a researcher present and followed up with 2 reinforcement/reminder emails that ask questions about strategy usage at 6 and 8 weeks after the session
The control is a primary care-related training program that is time-attention matched to Arm 1 but does not contain any content on anti-bias, anti-oppression, Indigenous peoples, or any content related to the unannounced Indigenous standardized patient encounter.
Eligibility Criteria
You may qualify if:
- Physicians, resident physicians, or nurse practitioners
- Non-Indigenous
- Affiliated with St. Michael's Hospital in Toronto, Canada
- Work in the Department of Family Medicine or the Emergency Department from January 2018 until 3 months post completion of training
You may not qualify if:
- Completion of Ontario Indigenous Cultural Safety Program or San'yas Indigenous Cultural Safety Training Program;
- Indigenous
- Intend to leave St. Michaels Hospital before 3 month post-intervention window
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- St. Michael's Hospital Foundationcollaborator
Study Sites (1)
Unity Health Toronto
Toronto, Ontario, M5B 1W8, Canada
Related Publications (6)
Brian Sinclair Working Group. Out of Sight. 2017. Accessed from: http://ignoredtodeathmanitoba.ca/index.php/2017/09/15/out-of-sight-interim-report-of-the-sinclair-working-group/
BACKGROUNDTruth and Reconciliation Canada. Honouring the truth, reconciling for the future: summary of the final report of the Truth and reconciliation Commission of Canada. Winnipeg: Truth and Reconciliation Commission of Canada. 2015
BACKGROUNDAllan, B. & Smylie, J. First Peoples, second class treatment: The role of racism in the health and well-being of Indigenous peoples in Canada. Toronto, ON: The Wellesley Institute. 2015
BACKGROUNDDevine PG, Forscher PS, Austin AJ, Cox WT. Long-term reduction in implicit race bias: A prejudice habit-breaking intervention. J Exp Soc Psychol. 2012 Nov;48(6):1267-1278. doi: 10.1016/j.jesp.2012.06.003.
PMID: 23524616BACKGROUNDMorrison MA, Morrison TG, Harriman RL, Jewell LM. Old-fashioned and modern prejudice towards Aboriginals in Canada. In book: The Psychology of Modern Prejudice, (Ed): Morrison Melanie A., Morrison Todd G., Nova Science Publishers., Inc. 2015 pp.277-305.
BACKGROUNDSmylie J, Rotondi MA, Filipenko S, Cox WTL, Smylie D, Ward C, Klopfer K, Lofters AK, O'Neill B, Graham M, Weber L, Damji AN, Devine PG, Collins J, Hardy BJ. Randomized controlled trial demonstrates novel tools to assess patient outcomes of Indigenous cultural safety training. BMC Med. 2024 Jan 9;22(1):3. doi: 10.1186/s12916-023-03193-y.
PMID: 38191406DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet Smylie, MD, MPH
Well Living House, St. Michael's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Participants were not informed of the unannounced Indigenous standardized patient (UISP) visit and thus blinded to this primary outcome measure. UISPs, research and site team members were blinded to participants' study arm allocation with the exception of the study coordinator, who facilitated enrollment in intervention and control training groups
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2023
First Posted
June 6, 2023
Study Start
March 1, 2018
Primary Completion
August 31, 2021
Study Completion
April 5, 2022
Last Updated
June 6, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share