- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02816294
Housing Prescriptions as Health Care
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:
Housing insecurity is a known risk factor for negative child health and developmental outcomes. The goal of this intervention is to reduce housing insecurity among families with young children as a mechanism for improving child health and improving other predictors on the pathway toward child health, including food security and maternal mental health status.
Rationale:
Children's HealthWatch data collected from 2010-2014 at Boston Medical Center, where the sample for this project will be recruited, found 32% of families were behind on rent in the past year and 7% of families moved more than twice in the past year. Previous research by Children's HealthWatch links multiple moves with increased risks of fair or poor child health and developmental delay. Families who are behind on rent are also at risk of fair or poor health, developmental delays, and are below average in length/height, a marker for under-nutrition. Given the significant associations between housing insecurity and child health outcomes, this project is tailored to address challenges faced by families who are severely housing insecure and who are classified as high health care utilizers by industry standards (defined as ≥ 3 emergency department visits in one year).
This research study design for this pilot is a randomized control trial whereby eligible families are randomly assigned to the intervention group or the control group. Those in the intervention group will be referred to a case manager and receive at least one of the six services offered through the program. Families in the control group will receive the current standard of care, which is a packet of outreach resources with information on housing and housing supports.
Purpose:
This study will investigate if this intervention is effective in improving housing stability and child health outcomes compared to current standard of care.
Study hypotheses:
Using data collected at baseline, six months, and 12 months after enrollment, the investigators will examine whether children ages 0-4, their siblings ages 0-11, and caregivers in the intervention group, vs. those in the control group, are more likely to have:
- Reduced score on housing insecurity assessment
- Reduced emergency department (ED) usage and hospitalizations for caregivers and children
- Improved adherence to well-child visits and immunization schedule
- Improved caregiver mental health, as defined by reduced depressive symptoms reported
- Increased family income and reduced reports of material hardships, including decreased food insecurity, defined by the gold-standard USDA 18-item scale; decreased energy insecurity, using the validated Children's HealthWatch screener; and decreased health care hardships, using the Children's HealthWatch screener.
The investigators will also examine ultimate net cost vs. savings per consumer to implement this Housing Prescription as Health Care program. Elements we will consider in economic models include:
- Costs of delivery of the intervention
- Savings from avoided health care costs
- Savings from avoided homelessness
- Increased family income as a result of this intervention
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Caregiver of family experiencing housing instability
- One or more family members in the household must have had >= 3 emergency room visits in the past year or child with medical complexity enrolled in comprehensive clinical case management program
- Caregiver of child <11 years, who receives primary care at Boston Medical Center
Exclusion Criteria:
- None of the members of the household have had >=3 emergency room visits in the past year nor medically complex child enrolled in case management.
- Family in stable housing
- Index child not a primary care patient at Boston Medical Center
- All children in household >11 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Housing Prescription
Participants in the intervention group will be referred to the Care Coordinator at Project Hope, who will conduct case management with the family to stabilize their housing.
The Care Coordinator will refer families all families to benefit maximization services and complete Problem Solving Education.
The Care Coordinator will also refer families as necessary to Medical-Legal Partnership Boston for pro-bono legal services and/or the Boston Housing Authority for priority on a subsidized housing waitlist.
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NO_INTERVENTION: Resource List
At present, for families facing housing insecurity, Children's HealthWatch offers paper resources with contact information for local social service agencies that may assist with housing stability.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in housing stability
Time Frame: baseline, six months, twelve months, 18 months, 24 months
|
Measured using self-report data on frequency of moves, risk of eviction, and rent affordability.
Data collected at baseline, six months, and twelve months to assess change in housing stability from baseline at each time point.
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baseline, six months, twelve months, 18 months, 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emergency Department utilization
Time Frame: baseline, six months, twelve months, 18 months, 24 months
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Measured using self-report data of number of emergency department visits in the year prior to the study, six months after enrollment, and twelve months after enrollment.
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baseline, six months, twelve months, 18 months, 24 months
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Adherence to well-child visits schedule
Time Frame: one year, two years
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Assessed by successful attendance of well-child visits recommended by the primary care physician and tracked in the electronic health record.
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one year, two years
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Adherence to immunization schedule
Time Frame: one year, two years
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Assessed by successful completion of vaccinations as recommended by the primary care physician and tracked in the electronic health record.
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one year, two years
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Caregiver mental health
Time Frame: baseline, six months, twelve months, 18 months, 24 months
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Measured using the Patient Health Questionnaire (PHQ-2) validated screener, which will be administered at baseline, six months, and twelve month.
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baseline, six months, twelve months, 18 months, 24 months
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Food security
Time Frame: baseline, six months, twelve months, 18 months, 24 months
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Measured using the United States Department of Agriculture Food Security Survey Module at baseline, six, and twelve month follow up
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baseline, six months, twelve months, 18 months, 24 months
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Energy security
Time Frame: baseline, six months, twelve months, 18 months, 24 months
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Measured using validated home energy screener from Children's HealthWatch at baseline, six, and twelve months
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baseline, six months, twelve months, 18 months, 24 months
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Health care hardships
Time Frame: baseline, six months, twelve months, 18 months, 24 months
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Measured by self-report of either foregoing health care due to other household expenses or trading off household expenses to pay for health care.
Data will be collected at baseline, six, and twelve months.
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baseline, six months, twelve months, 18 months, 24 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan Sandel, MD, MPH, Boston Medical Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-35188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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