Nurturing Our Relations: A Randomized Controlled Trial of Virtual Reality Indigenous Cultural Safety Training Compared to Control for Obstetric and Neonatal Care Nurses

Background Anti-Indigenous racism in healthcare is common and harmful. The Truth and Reconciliation Commission of Canada's Calls to Action include calling for Indigenous cultural safety (ICS) training for healthcare professionals and students. Emerging research has revealed some challenges related to ICS training for healthcare professionals, including gaps in tailored and scaffolded skills-based ICS training that limit healthcare providers ability to apply ICS knowledge and insights in their specialty practices. ICS training also commonly requires skilled facilitation, which can be challenging in the face of Indigenous health human resource shortages. Additionally, although there has been a significant increase in the development and adoption of ICS training across Canada, direct evaluation of the patient and system level impacts of these programs is limited. Advancements in computerized gaming technologies and virtual simulation open up new opportunities and are experiencing rapid uptake in other areas of health care professional training.

This study will apply a randomized controlled trial design to test newly developed virtual reality Indigenous standardized patient encounters as an Indigenous cultural safety training tool for labour and delivery birthing, post-partum and neonatal intensive care unit (NICU) nursing staff. Building on previous pilot work, relational quality and clinical guideline practice adherence during in person Indigenous standardized patient encounters will serve as the primary, patient-centred evaluation outcomes. The study hypothesis is that immersive, simulated patient encounters that are tailored to healthcare professionals' field of expertise will have a positive effect on patient care experiences.

This study responds to TRC calls to action regarding implementation of ICS training by continuing to advance understanding of patient-level impacts of ICS training and also examines the potential of VR as a tool for skills-based health care provider ICS training that is tailored to specialized practice roles and contexts.

Method

The primary objective of this study is:

To understand and compare the relational and clinical decision-making impacts of virtual reality cultural safety training intervention compared to a time-matched control, online training in an unrelated clinical domain, for labour and delivery birthing, postpartum, and neonatal care unit nurses in two large urban academic teaching hospitals in Canada.

The secondary objective of this study is:

To assess the acceptability and feasibility of virtual reality as a modality for Indigenous cultural safety training amongst labour and delivery, postpartum, and neonatal care nurses in large urban hospital settings.

Study Design This study is a parallel group randomized controlled design. Participants will be randomized into one of two study arms. Participants in Arm #1 (Invention arm) will complete two one-hour virtual reality Indigenous cultural safety training sessions supported by in-person trained facilitators over a two-week period. The curriculum in Arm #1 was developed by the research team and uses branching teaching stories of simulated patient encounters design. Participants in Arm #2 (Control arm) will complete time-matched online clinical training on a non-ICS related topic (such as sepsis education, Rhogam training, or Society of Obstetrics and Gynecology of Canada guidelines training).

Participants in both arms will participate in an in person Indigenous standardized patient encounter assessment 12 weeks post intervention. The Indigenous standardized patient encounter assessment will be modelled after the OSCE (Objective Structured Clinical Examination) nursing students have as a routine part of their education training. The Indigenous Standardized Patient (ISP) will be trained to evaluate the nurse participant's relational skills and adherence to clinical practice guidelines.

Setting The virtual reality and online clinical training sessions will occur as individual in-person training sessions for obstetric and neonatal nurses working in St. Michael's and St. Joseph's hospitals. To accommodate busy schedules and unpredictable ward environments, the sessions will be hosted during working shifts at the hospital of participant employment. An extra nurse will be scheduled to cover participants as they leave the ward for their training. Food and drink will be provided for participants.

Participants Participants in this study will include non-Indigenous registered nurses (RN) recruited from the labour and delivery, postpartum, and neonatal intensive care in-patient wards at St. Michael's and St. Joseph's hospitals. To be eligible participants must indicate their intention to remain at St. Michael's and St. Joseph's hospital for at least five months following completion of their intervention, ensuring they are able to complete all necessary data collection tasks for the project.

Recruitment and Study Enrollment Working with each department head, Dr. Janet Smylie will conduct an information session about the study. The Study Coordinator will work with the department heads to identify an appropriate departmental staff member to send a recruitment letter via email and mail to all nurses within the labour and delivery birthing, postpartum, and neonatal intensive care units. With permission from the department heads, promotional materials for the study will be displayed in obstetric, postpartum, and neonatal care departments. Interested staff members will be instructed in the promotional materials to contact the study coordinator via email or phone to learn more about the study.

The Study Research Coordinator, who is part of the Well Living House research team and at arm's length from participant's clinical departments, will be responsible for answering questions about the study and keeping track of all SMH and SJH staff (name and email address) who express interest in the study. The Study Research Coordinator will review the study information, conduct the eligibility screening questionnaire, and obtain consent through either in-person or remotely via phone call or email. The study information letter includes information about the study purpose, procedures, risks, benefits, and measures taken to protect privacy and confidentiality.

Once signed consent has been obtained by email or in-person, the Study Research Coordinator will randomize the participants into one of the two study arms, give them a participant id #, and schedule participants in for their educational session including date, time, and place to attend. The Study Research Coordinator will also provide all participants with an email link to complete baseline questionnaires. The baseline questionnaires must be completed prior to proceeding with the intervention. Participants will receive an email reminder to complete their baseline questionnaires one week and one day prior to their educational session. Paper informed consent will be stored in a locked cabinet at Unity Health and any electronic copies of signed consent will be stored on an encrypted password-protected server at Unity Health.

Participants can withdraw from the study at any time. As a thank you for their time and participation, the study team will purchase a gift for the department in lieu of individual honoraria which are precluded for participation taking place during paid work hours. An individual $50 honoraria will also be offered to participants for completing the pre- and post-intervention surveys (outside of work time). All participants will be given the opportunity to register, at no cost, and complete the VR Indigenous cultural safety training following completion of the study.

Randomization and Masking Participants will be randomized into the study as shown in Figure 1 to either Arm #1 (intervention) or Arm #2 (control). Study investigators, Indigenous standardized patients, and site team members will be masked to participant study arm allocation except for the study co-ordinator (who will facilitate enrollment and completion of the intervention and control arms) and one study investigator (who will co-facilitate the VR intervention debriefing). Outcome analysis and interpretation will be led by masked study team members.

Interventions VR Training Module Participants randomized into Arm #1 will receive virtual reality Indigenous cultural safety education. The intervention consists of two sessions over a two-week period of approximately one hour that will each include an orientation to the VR technology, a 15-minute interactive virtual reality patient care scenario, and a facilitated debrief. The timing and repetition of the sessions consistent with adult learning pedagogies and VR re-enforcement psychology.

The intervention has been designed to provide tailored, practice-oriented learning and skills and build on pre-existing Indigenous cultural safety training, that may have already advanced knowledge, awareness and insights regarding Indigenous experiences, colonization, and attitudinal and systemic anti-Indigenous racism. Each weekly VR intervention session is comprised of a teaching story that has been translated into an immersive simulated patient encounter with a series of interactive choices, each leading to a different client response. The teaching stories have been co-designed with Indigenous health service providers and Indigenous health service users to address similar cultural safety and anti-racist learning outcomes (self-reflexivity, bias awareness and challenging stereotypes, culturally safe and anti-racist communication and clinical decision-making) but are varied in terms of medical context and patient dynamics. Participants will be encouraged to try all branching scenario options.

The session will include a brief 5-10-minute introduction and orientation to VR. Two facilitators will be present during the VR sessions. One of the facilitators will be the nurse/peer study coordinator, the other will be a study investigator with a high level of skill in facilitating mixed conversations about anti-Indigenous racism and Indigenous cultural safety. Facilitators will also be able to assist with any tech support needed for nurse participants to operate the VR headsets. In alignment with online healthcare provider education, a short immediate debrief will be provided after the VR scenarios. In total, each educational session will run for 50-55 minutes, with nurse staffing coverage for 60 minutes per participant.

Online non-ICS Clinical Training (Comparative) Participants randomized into Arm #2 will complete a time-matched online clinical education session on a topic unrelated to ICS. These sessions will be drop-in hosted concomitantly with VR training sessions. Facilitators will be present during these sessions to support set-up. Similar to the intervention, two sessions will be held one week a part (time matched to intervention). The content will be on a subject matter relevant to participant nurses that is unrelated to Indigenous cultural safety. We will provide a range of online control training materials for participants to choose from that will appeal to various departments (labour & delivery, postpartum, and neonatal intensive care nursing). We will collaborate with Nurse managers to provide materials that are relevant and not duplicative of existing nursing training. Potential examples we have currently sourced include: Choosing Wisely Canada: SOGC Gynecology, and Choosing Wisely Canada: SOGC Obstetrics. These control training options will come from sources vetted by Nurse managers and include sources like Society of Obstetrics & Gynecology Canada, that are of a high standard. Completion of both intervention and control sessions will be tracked.

Outcome Measures Primary outcomes are focused on the assessment of relational quality and clinical skills for labour and delivery and neonatal nurses and will be gathered by a trained Indigenous standardized patient during an in person simulated patient encounter using structured assessment tools occurring 10-12 weeks post intervention/control training.

Secondary outcomes will assess Indigenous explicit and implicit bias and perceived cultural safety competency also using structured assessment tools. Secondary outcomes will also include assessment of acceptability and feasibility using a self-report survey.

Finally, participant training within the hospital allows for researcher observation and field note documentation of the clinical environment during training and assessment. The clinical environment is known to play a role in medical learner's motivation, receptivity, and application of continuing medical education, through processes related to learner mental and emotional state, interpersonal work dynamics, and departmental culture. Learner mental and emotional state has also been shown to influence cultural safety education uptake and experience. Documenting the clinical environment that is simultaneously surrounding the training and assessment sessions may provide additional insights into nurse participant cultural safety learning and VR acceptability.

Sample Size The aim is to recruit 60 participants in each study arm, for a total of 120 participants. While there is a paucity of literature specific to ICS health care provider training using patient encounter based relational quality and clinical practice guideline adherence measures, the Reconciling Relationships pilot study is instructive with respect to sample size. For example, in the Reconciling Relationships pilot study, 4/15 (26.7%) control participants were highly recommended to friends and family by trained Indigenous actors following an evaluative Indigenous standardized patient encounter compared to 6/11 (54.6) of participants who completed a brief Indigenous focused anti-bias intervention - a different training intervention involving one 45-minute session of computer based interactive anti-bias education and two follow-up emails. Assuming that the more immersive and repeated VR training intervention will have an effect on relational quality that is at least equal to the brief screen based anti-bias intervention, then a sample size of 60 per study arm will allow for 20% attrition in each study arm as per the sample size calculation below.

Sample size calculation using ClinCalc's sample size calculator (clinicalc.com) Parameters: Alpha 0.5; Power 80%; dichotomous endpoint (highly recommended versus not highly recommended); Incidence group 1 - 26.7%; Incidence group 2 - 54.6% Required minimal sample size: Group 1 - 47; Group 2 - 47; Total 94

Data Collection As described above primary outcome measures will be scored by trained Indigenous standardized patients immediately following the in-person Indigenous standardized patient (ISP) encounter which will be scheduled at 10-12 weeks post-intervention/control training. Female Indigenous professional actors of reproductive age without confounding health conditions will be trained to perform and score one patient encounter scenario in which they present as an Indigenous patient presenting on the ward with post-partum pain and requesting pain management, 36 hours after a caesarian section birth. ISP training will draw on the success of our pilot study and include standardization of scoring for this scenario using six mock encounters that demonstrate varying levels of health care provider competence. Immediately following the standardized patient assessment participants will have the opportunity to debrief in person with a member of the study team. Debrief will follow Five Phases of Trauma-Informed Psychologically Safe (TIPS) Debriefing Framework for healthcare simulation learning in a group setting.

One week following the ISP visit, participants will receive an email reminder to complete secondary outcome measures using the provided link to the Redcap platform.

Similar to an OSCE, participants can receive individual feedback related to their scoring in relational skills and adherence to clinical practice guidelines immediately following the assessment.

Researcher observation and field note documentation of the clinical environment during training and assessment will be conducted by the same co-investigator who is co-facilitating the training sessions and supporting the debrief of participants following their in-person ISP assessment. Daily semi-structured field notes will be completed at the beginning and end of each training and assessment day.

Data Management As described above, collected data will include data collected by online and paper surveys and assessment tools; field notes; and direct outcome measure scoring by standardized patients. Data confidentiality and security will be maintained throughout the study as follows: Participant data will be assigned a unique participant identifier to ensure anonymity. A master list linking participants to their identifier will be stored in a file separate from the rest of the data collected and only authorized team members will have access to the raw data. Paper survey copies will be uploaded to SMH encrypted password-protected secure network server and retained in a locked cabinet in Unity Health. All data collected will be stored on SMH encrypted password-protected secure network server. All ISP evaluations will also be anonymized, and analysis and subsequent dissemination will be reported in aggregate form to protect the confidentiality of the participants.

Data Analysis Quantitative data collected from Indigenous standardized patient scoring of primary outcome measures and baseline and post-intervention scores for secondary outcome measures will be analyzed using the appropriate software and statistical techniques in consultation with a biostatistician.

Qualitative data includes open ended responses to the VR feasibility and acceptability surveys and observational field notes. The former will be summarized and shared as lessons learned. The later will be compiled and thematically analyzed using an applied critical practice enhancement approach.

Ethics and Oversight The data collected will be information from non-Indigenous nursing participants and is therefore out of scope for the formal application of Indigenous data sovereignty principles and practices. This study does, however, have several layers of Indigenous oversight to ensure the study design and implementation is conducted in a responsible manner and doesn't have any negative consequences for Indigenous patients and the Indigenous community served by SMH and SJH. Principle investigators for this study are affiliated with Well Living House, the Indigenous research action hub of Unity Health Toronto, which is guided by a Counsel of Grandparents. Seventh Generation Midwives Toronto, an Indigenous midwifery practice group, is a community partner on this study and involved in all aspects of the study. The research team also liaises with the Office of Indigenous Wellness, Reconciliation and Partnerships at Unity Health Toronto. This study will not have an external data monitoring committee due to the low-risk nature of the educational study.

Dissemination Plans The results of this study will be presented back to participant family and maternity care units at special rounds; across participant and interested hospitals, at conferences, in publications, and other public academic forums. Participants' names and other identifying information will not be included in any public documents.