NCT04012697

Brief Summary

Peer support workers with lived experience of homelessness will provide advocacy, supportive counselling, assistance with navigating the system, and role-modeling for people experiencing homelessness in emergency departments in the Niagara region of Ontario, Canada. Previous research has demonstrated that people experiencing homelessness experience barriers to care and poor health outcomes, including increased risk of dying, and are frequent users of the emergency department for physical and mental health needs. The benefits of peer support have been studied in hospital psychiatric units and with people experiencing homelessness, but no studies have yet explored the potential impact of peer support workers on homelessness in the emergency department. The investigators plan to do a 12-month randomized study of peer support workers compared to usual care in the emergency department, and evaluate outcomes such as physical health, mental health, addictions, and behaviours, as well as cost-effectiveness and changes in how people experiencing homelessness seek health care. The investigators hope that the findings of this study will provide additional knowledge and evidence for future efforts to improve care for people experiencing homelessness.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

July 2, 2019

Last Update Submit

February 6, 2023

Conditions

Keywords

Survival analysisQuantitative analysisPatient-reported outcomesRandomized-controlled trialHomelessnessHealth services researchAdministrative health dataPeer support

Outcome Measures

Primary Outcomes (11)

  • Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hospitalizations, measured using administrative health data

    The primary outcome of the study includes the number of hospitalizations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of days spent in hospital, measured using administrative health data

    The primary outcome of the study includes the number of days spent in hospital. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of emergency department visits, measured using administrative health data

    The primary outcome of the study includes the number of emergency department visits. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of hours spent in the emergency department at each visit, measured using administrative health data

    The primary outcome of the study includes the number of hours spent in the emergency department at each visit. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in the number of procedures performed in the emergency department, measured using administrative health data

    The primary outcome of the study includes the number of procedures performed in the emergency department. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in mean from the pre-intervention 12-month baseline to the post-intervention 12-month period in procedures performed during hospitalizations, measured using administrative health data

    The primary outcome of the study includes the number of procedures performed during hospitalizations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in proportions from the pre-intervention 12-month baseline to the post-intervention 12-month period in diagnoses at the time of discharge from the emergency department, measured using administrative health data

    The primary outcome of the study includes the diagnosis at time of discharge from the emergency department. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in mortality, measured using administrative health data

    The primary outcome of the study includes mortality. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in overdose presentations, measured using administrative health data

    The primary outcome of the study includes overdose presentations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in proportion from the pre-intervention 12-month baseline to the post-intervention 12-month period in psychiatric presentations, measured using administrative health data

    The primary outcome of the study includes psychiatric presentations. This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

  • Change in proportion from pre-intervention 12-month baseline to post-intervention 12-month period in composition of presenting complaints to the emergency department, measured using administrative health dat

    The primary outcome of the study includes the composition of presenting complaints to the emergency department and potential differences over time in the proportions of different presentations (e.g., physical health vs. mental health, Canadian Triage and Acuity Scale (CTAS) levels). This outcome will be evaluated through linkage and evaluation of administrative data hosted at Niagara Health through Decision Support Services. Consent will be obtained from participants to perform data linkage with Niagara Health databases and collect information on health services use for the 12-month period preceding and 12-month period following study enrollment.

    12 months pre-study enrollment and 12-months post-study enrollment

Secondary Outcomes (10)

  • Mean change from baseline in psychiatric symptoms on the Colorado Symptom Index (CSI) at 6 months

    6 months

  • Mean change from baseline in psychiatric symptoms on the Colorado Symptom Index (CSI) at 12 months

    12 months

  • Mean change from baseline in psychopathology and crime/violence on the Global Appraisal of Individual Needs - Short Screener (GAIN-SS) at 6 months

    6 months

  • Mean change from baseline in psychopathology and crime/violence on the Global Appraisal of Individual Needs - Short Screener (GAIN-SS) at 12 months

    12 months

  • Mean change from baseline in health status on the EuroQol-5D-5L (EQ-5D-5L) at 6 months

    6 months

  • +5 more secondary outcomes

Other Outcomes (5)

  • Cost-effectiveness analysis of peer support worker intervention as compared to usual care at 12 months

    12 months

  • Survival analysis of health service use/outcomes using administrative health data

    From the date of assignment until the date of first emergency department readmit, second emergency department readmit, and admission to an inpatient service, assessed up to 12 months

  • Non-parametric survival analysis using administrative health and peer support questionnaire data to evaluate changes in health care provision between contacts with the peer support worker

    From the date of assignment until the date of each subsequent visit, assessed up to 12 months

  • +2 more other outcomes

Study Arms (2)

Peer Support

EXPERIMENTAL

Peer support services from a peer support worker in the emergency department.

Behavioral: Peer Support

Usual care

NO INTERVENTION

Usual care in the emergency department.

Interventions

Peer SupportBEHAVIORAL

Participants randomized to the intervention group will be seen by the peer support worker during their stay in the emergency department. The goal of the peer support worker's practice is to address the participant's wellness from a holistic point of view that includes their relationships, connections to the community, general well-being, and sense of empowerment, with an overall focus on quality-of-life goals (Sunderland et al., 2013). The peer support worker will provide a multi-faceted intervention, which aims to foster a peer-to-peer relationship encompassing elements of empathic communication, brief supportive counseling, advocacy for non-medical needs in hospital, liaising and collaborating with medical and nursing staff, motivational interviewing, and connection with programs in the community.

Peer Support

Eligibility Criteria

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

You may qualify if:

  • Canadian citizen or permanent resident
  • Resident of Ontario in the past 12 months
  • Age 18 or over
  • Absolute homeless (e.g., living outside, including but not limited to abandoned buildings, vehicles, transit stations; residing in shelters; residing in hotel/motel rooms)
  • Hidden homeless (e.g., living with others, residing in transitional housing)

You may not qualify if:

  • Not a Canadian citizen or permanent resident of Canada
  • Not a resident of Ontario for the majority of the past 12 months
  • Under the age of 18
  • Refusal to disclose housing, citizenship, or residential status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

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MeSH Terms

Conditions

Health BehaviorPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

BehaviorTreatment Adherence and Compliance

Study Officials

  • Suneel Upadhye, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Baseline data collection is performed prior to randomization and group assignment. Data collection at each of the following Time points is performed by research assistants who are blinded to the participant's group assignment. Investigators are likewise blinded to the group assignment of participants. Participants are not blinded given the impracticality of blinding assignment to the group receiving peer support vs. receiving usual care.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Pragmatic randomized controlled superiority trial with parallel intervention and usual care groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 9, 2019

Study Start

January 1, 2020

Primary Completion

March 19, 2020

Study Completion

March 19, 2020

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations