NCT05890144

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

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

3.5 years

First QC Date

May 12, 2023

Last Update Submit

June 5, 2023

Conditions

Keywords

Indigenous HealthAboriginal HealthRacismImplicit BiasCultural SafetyCultural Safety Training

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")

EXPERIMENTAL

20 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.

Other: Big Canoe

Brief Intervention ("Little Canoe")

ACTIVE COMPARATOR

20 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.

Other: Little Canoe

Control

OTHER

20 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.

Other: Control

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).

Intensive Intervention ("Big Canoe")

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

Brief Intervention ("Little Canoe")
ControlOTHER

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.

Control

Eligibility Criteria

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

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

Study Sites (1)

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

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/

    BACKGROUND
  • Truth 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

    BACKGROUND
  • Allan, 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

    BACKGROUND
  • Devine 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: 23524616BACKGROUND
  • Morrison 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.

    BACKGROUND
  • Smylie 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.

MeSH Terms

Conditions

RacismBias, Implicit

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Janet Smylie, MD, MPH

    Well Living House, St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

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

Locations