Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03369678 |
| Other study ID # |
H17-01548 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 28, 2017 |
| Est. completion date |
March 15, 2021 |
Study information
| Verified date |
April 2021 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Emergency Departments (EDs) in Canada often operate over-capacity and are under significant
pressures. In this environment, particular groups of people experience inadequate and
inequitable treatment in EDs, including Indigenous people, racialized newcomers, people with
mental illnesses, those living in unstable housing or facing homelessness, experiencing
interpersonal violence or using substances, and people involved in sex work. Stigma and
discrimination in health care deter people from accessing care, interfering with effective
care delivery, increasing reliance on EDs, and increasing human and financial costs. This
project will develop and test a framework for health equity interventions to promote the
provision of equity-oriented care in EDs.
Description:
This study examines the feasibility, process, and impacts of implementing an
evidence-informed framework for interventions to enhance the capacity of Emergency
Departments to provide high-quality care to people at greatest risk of experiencing health
and health care inequities. The framework integrates evidence-based strategies to mitigate
discrimination and racism experienced by Indigenous people, and stigma and discrimination
faced by people of all ethnicities related to substance use, housing instability, sex work,
gender, or mental illnesses. The study tests organizational interventions that incorporate
principles of equity-oriented care, trauma- and violence-informed care, harm reduction, and
cultural safety to optimize care first for Indigenous people, and then for a range of people
who commonly face stigma and discrimination.
Approaching EDs as complex adaptive systems, the study aims to:
1. Engage EDs in a participatory process to enhance capacity for equity-oriented care
2. Examine impacts of equity-oriented interventions on processes of care, patient
experiences of care and short-term outcomes, staff attitudes, confidence, behaviours and
job satisfaction, and cost
3. Analyze the cost-effectiveness and feasibility of implementing the interventions and
scale-up potential in other contexts.
This mixed-methods study incorporates administrative data, survey data with standardized
tools, in-depth interviews, analysis of policy and organizational structures, and
observational data. The study is divided into multiple phases of data collection. This phase
focuses on surveys of ED staff members and patients. The structured surveys use standardized
tools and measures, and aim to capture staff and patients' experiences of ED care. Surveys
will be conducted at three to four timepoints.
PATIENT SURVEYS will draw on patient self-reports to measure changes over time in processes
of care and perceived quality of care. These indicators will be measured through structured,
researcher-facilitated surveys conducted with a sample of 250-300 patients at each site at up
to four points in time, providing pre- and post-intervention comparisons.
At each data collection point, all patients who are able to provide informed consent (in the
languages available - see below) will be invited to participate as they present for care or
during the course of their visit at each emergency unit. Researchers will circulate
throughout the emergency department, inviting participation by all patients who are conscious
and able to consent.
Recruitment will occur over a period of 1-3 weeks in 6 hour blocks. The blocks will span all
24 hours, and as many days of the week as possible.
Surveys will not delay or interrupt provision of care.
Section 1 of the survey can be completed at any time during the patient's Emergency visit;
Section 2 will be completed after the patient has been cleared for discharge from the
Emergency (discharged to community or admitted). The system for notifying the researchers of
discharge status will align with the usual procedures at each ED. If at all possible, Section
2 will be completed before the patient leaves the hospital, in a private space close to the
ED. If the patient is unable or prefers not to complete Section 2 in hospital, then a phone
follow up will be offered; if the patient does not have a phone and is willing and able to do
so, they will be invited to drop in at a specified outpatient or community clinic in the
following 5 days.
Recruitment and data collection will continue until target samples of 250-300 completed
surveys per site per time point are achieved. Every effort will be made to recruit
participation of people from diverse ethnocultural groups. Given the research objectives of
this study, recruitment will be prioritized for people who self-identify as Indigenous as
well as individuals who are at risk of experiencing stigma and discrimination (e.g., those
with diagnoses related to mental illness, HIV, substance use).
Researchers will work in pairs during each time block conducting recruitment and interviewing
simultaneously. Following processes already in use at one of the partnering ED sites and
prior practices, researchers will collect data directly on tablets using structured survey
instruments.
A team of trained researchers will work with ED staff members (e.g., triage staff, unit
clerk, charge nurse, etc.), to invite participation by those patients who meet the
established eligibility criteria. In urgent cases, participants will be told about the study
by staff after their immediate/urgent health concerns have been addressed. Researchers will
approach potential participants to explain the study and seek consent to participate. Once
consent is obtained, the researcher will enroll the participant in the study, complete
Section 1 of the survey, and collect minimal contact information (i.e., name and phone number
- see Patient Survey Guide) to be used for follow up in the event that patients elect to be
interviewed by phone or off-site at a later time.
The brief structured survey (10-15 minutes per section) will be facilitated by a researcher
with patients who consent. Both sections will be completed within a maximum of 5 days of the
ED visit in a private area close to the ED, where participants' responses cannot be overheard
by others and confidentiality can be maintained, or by phone or at an agreed upon drop-in
location within the hospital. Patients will be provided with an honorarium for completing
each section of the survey. Transportation and childcare expenses will be reimbursed for
those who choose an in-person follow up to complete the survey. A detailed safety protocol,
adapted from previous studies, will be used to guide all interactions.
Structured surveys conducted in all waves will be facilitated by a trained researcher,
following an established Patient Survey Guide and using a computer-assisted data platform
(UBC Survey Tool) on a tablet device. This tablet interface will allow the participant and
researcher to view questions and select responses together on the screen.
STAFF SURVEYS All staff members at each partnering ED site will be invited to complete a
survey questionnaire, which will include measures aligned with the theoretical principles
underlying the equity-oriented framework being tested (i.e., cultural safety, trauma- and
violence-informed care, and harm reduction).
Staff members will be invited to complete a structured questionnaire (see Staff Survey
Guide), to be administered online or completed on paper. To facilitate this, copies of the
survey will be available within each emergency department. In addition, in-person sessions
will be held at each emergency department. Light refreshments will be provided and
researchers will be on-hand to answer any questions about the study and the survey itself.
Participants will be encouraged to attend these sessions on their break or at shift-end, and
can choose to complete the surveys independently on paper or directly on a study tablet.
A preamble to the survey will explain the study and include the consent form. Completion of
the survey - either online or on paper - will imply consent.
Staff assessments will be conducted at three to four time points, to coincide with milestones
in the implementation of the intervention being tested. When possible, staff will be
encouraged to complete the survey outside of work hours, during breaks, or at the start or
end of their shifts.
