NCT06723093

Brief Summary

The study design is a cohort study with a propensity score-matched control group and difference-in-difference analysis to evaluate intervention effectiveness. A hybrid type 1 effectiveness-implementation study framework is used that incorporates mixed methods to determine clinical effectiveness and explore implementation and participant well-being. Participants are selected based on their utilization of health services. Selection favoured those individuals with the most health service utilization. A control group will be created by selecting individuals from administrative hospital records that are propensity-score matched to the individuals in the treatment group (1:4 pair). The hybrid type 1 effectiveness-implementation study framework was used to guide the selection of study aims and outcomes to focus primarily on clinical effectiveness, while also exploring implementation-related factors. The primary objective of the study is to evaluate the impact of the Initiative on the number of emergency department visits and days spent in the hospital. The secondary objectives are to 2) evaluate the impact of the Initiative on program participants' health and well-being, 3) evaluate the implementation of the Initiative and assess program fidelity and barriers, and 4) to calculate the cost avoidance and cost-effectiveness of the Initiative.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress60%
Nov 2024May 2027

Study Start

First participant enrolled

November 6, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

December 9, 2024

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

November 21, 2024

Last Update Submit

December 4, 2024

Conditions

Keywords

homelessness

Outcome Measures

Primary Outcomes (2)

  • Number of emergency department visits

    The primary objective of the study is to evaluate the impact of the Social Medicine Housing Initiative on the number of emergency department visits for University Health Network super utilizers compared to a propensity score-matched cohort. It is hypothesized that study participants who participate in the Housing Initiative will show a reduction in acute care utilization (emergency department visits) during the 30-month outcome ascertainment period.

    30 Months

  • Days spent in the hospital

    The primary objective of the study is to evaluate the impact of the Social Medicine Housing Initiative on the number of days spent in the hospital for UHN super-utilizers compared to a propensity score-matched cohort. It is hypothesized that study participants who participate in the Housing Initiative will show a reduction in acute care utilization (in-patient hospital days) during the 30-month outcome ascertainment period

    30 Months

Secondary Outcomes (4)

  • Tenant Health status

    30 months

  • Tenant Mental health

    30 months

  • Tenant Substance Use

    30 months

  • Tenant history of violence

    30 months

Other Outcomes (2)

  • Health care expenditure analysis

    30 months

  • Cost effectiveness analysis

    30 months

Study Arms (2)

University Health Network Standard Care

EXPERIMENTAL

The Social Medicine Housing Initiative is part of standard care and is not contingent on participating in any research activities. Patients who participate in the Housing Initiative will have the option to participate in the research study. The Social Medicine Housing Initiative provides a housing-first approach which offers housing to individuals without prerequisites (e.g., requiring cessation of substance use, adherence to treatment). Through the Initiative, patients will receive access to permanent supportive housing and support services based on the Social Medicine model. Participants will not only have access to housing but will also be provided with customized social and medical support within and beyond the University Health Network, tailored to their specific needs and preferences.

Behavioral: Social Medicine Housing Initiative

Propensity score matched cohort

NO INTERVENTION

The Institute of Clinical Evaluative Sciences of Canada database will provide health administrative data on the Housing Initiative individuals and similar individuals. Each individual in the treatment arm will be matched with four individuals (1:4 pair) in the control arm who are observationally similar. The propensity score-matched cohort method will control for demand-side characteristics that reflect the utilization of health care services, focusing on the use of emergency department visits and inpatient hospital days, nursing home use, and inpatient utilization for severe mental illness. To assess whether the propensity score model has adequately specified, the authors will examine whether the distribution of measured baseline covariates is similar between treated and untreated subjects with the same estimated propensity score.

Interventions

Through the Social Medicine Housing Initiative, patients will receive access to permanent supportive housing and support services based on a social medicine model. The Housing Initiative provides a housing-first approach which offers housing to individuals without prerequisites (e.g., requiring cessation of substance use, adherence to treatment). Housing will be provided through a rent-geared-to-income model, with participants paying up to 30 percent of their income towards rent. Participants will also be provided with customized social and medical support within and beyond the University Health Network, tailored to their specific needs and preferences. Patient care will be a collaborative effort involving the housing provider, the Social Medicine team, and community agencies.

University Health Network Standard Care

Eligibility Criteria

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

You may qualify if:

  • The Housing Initiative is part of standard care and is not contingent on participating in any research activities. Patients that participate in the Housing Initiative will have the option to participate in the research study.
  • To qualify for housing through the initiative, patients must have had 2 or more inpatient admissions or 6 or more visits to the emergency department in the past 6 months. They must also either identify as Indigenous or be currently without housing, which is defined as having spent at least one night in a shelter or having received assistance from city-funded street outreach providers in the past 90 days. Historically marginalized groups, including people with disabilities, women, gender-diverse individuals, and Indigenous people, are given priority for housing. Eligible patients are prioritized for housing offers based on their use of the University Health Network emergency departments in the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

90 Dunn

Toronto, Ontario, M6K 2R6, Canada

RECRUITING

Study Officials

  • Andrew Boozary, MD MPP CCFP

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew S Boozary, MD MPP CCFP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study design is a cohort study with a propensity score-matched control group and difference-in-difference analysis to evaluate intervention effectiveness. A hybrid type 1 effectiveness-implementation study framework is used that incorporates mixed methods to determine clinical effectiveness and explore implementation and participant well-being.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director, Population Health and Social Medicine Gattuso Centre for Social Medicine, University Health Network

Study Record Dates

First Submitted

November 21, 2024

First Posted

December 9, 2024

Study Start

November 6, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

December 9, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations