Housing InstabilityNCT02816294
Housing Prescriptions as Health Care
A study testing Housing Prescription in people with Housing Instability and High Emergency Department Utilization, run by Boston Medical Center at 1 site in United States.
Trial summary
Housing Prescriptions as Health Care is a research project studying the effects of an innovative intervention that combines services across the health, housing, social and legal service sectors in order to improve housing stability and child health outcomes among participants. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Housing Instability, High Emergency Department Utilization, Medical Complexity
- What is being tested?
- Housing Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Housing Prescriptions as Health Care is a research project studying the effects of an innovative intervention that combines services across the health, housing, social and legal service sectors in order to improve housing stability and child health outcomes among participants. The housing intervention developed for this study specifically addresses issues including families who are: paying more than 50 percent of income on rent or utilities, moving frequently, experiencing homelessness, but are not eligible for shelter through the Department of Housing and Community Development's Emergency Assistance program, or were unable to pay rent on time in the past year. This research explores how coordinated and comprehensive housing services offered through intensive case management improves housing stability and health outcomes for families of young children.
Read the 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
- Being tested
- Housing Prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Housing PrescriptionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Housing Prescription | Experimental | 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. Receives: Behavioral: Housing Prescription |
| Resource List | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in housing stability
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.
Measured: baseline, six months, twelve months, 18 months, 24 months
Secondary outcomes (7)
Emergency Department utilization
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.
Measured: baseline, six months, twelve months, 18 months, 24 months
Adherence to well-child visits schedule
Assessed by successful attendance of well-child visits recommended by the primary care physician and tracked in the electronic health record.
Measured: one year, two years
Adherence to immunization schedule
Assessed by successful completion of vaccinations as recommended by the primary care physician and tracked in the electronic health record.
Measured: one year, two years
Caregiver mental health
Measured using the Patient Health Questionnaire (PHQ-2) validated screener, which will be administered at baseline, six months, and twelve month.
Measured: baseline, six months, twelve months, 18 months, 24 months
Food security
Measured using the United States Department of Agriculture Food Security Survey Module at baseline, six, and twelve month follow up
Measured: baseline, six months, twelve months, 18 months, 24 months
Energy security
Measured using validated home energy screener from Children's HealthWatch at baseline, six, and twelve months
Measured: baseline, six months, twelve months, 18 months, 24 months
Health care hardships
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.
Measured: baseline, six months, twelve months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startOct 2016
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Housing InstabilityStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Project Hope Boston, Boston Housing Authority, City of Boston, Nuestra Comunidad Community Development Corporation, Medical Legal Partnership Boston, The Boston Foundation, Blue Cross Blue Shield
- Responsible party
- Sponsor
- Investigators
- Megan Sandel, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816294
- Sponsor's protocol ID
- H-35188
- Status last verified
- Mar 2021
- First submitted
- 22 Jun 2016
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cutts DB, Meyers AF, Black MM, Casey PH, Chilton M, Cook JT, Geppert J, Ettinger de Cuba S, Heeren T, Coleman S, Rose-Jacobs R, Frank DA. US Housing insecurity and the health of very young children. Am J Public Health. 2011 Aug;101(8):1508-14. doi: 10.2105/AJPH.2011.300139. Epub 2011 Jun 16.
PubMed 21680929
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Housing Prescriptions as Health Care
- ClinicalTrials.gov ID
- NCT02816294
- Acronym / sponsor ID
- H-35188
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Project Hope Boston, Boston Housing Authority, City of Boston, Nuestra Comunidad Community Development Corporation, Medical Legal Partnership Boston, The Boston Foundation, Blue Cross Blue Shield
- Study start
- Oct 2016 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Housing Prescriptions as Health Care is a research project studying the effects of an innovative intervention that combines services across the health, housing, social and legal service sectors in order to improve housing stability and child health outcomes among participants. The housing intervention developed for this study specifically addresses issues including families who are: paying more than 50 percent of income on rent or utilities, moving frequently, experiencing homelessness, but are not eligible for shelter through the Department of Housing and Community Development's Emergency Assistance program, or were unable to pay rent on time in the past year. This research explores how coordinated and comprehensive housing services offered through intensive case management improves housing stability and health outcomes for families of young children.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Housing Prescription | Experimental | Behavioral: Housing PrescriptionParticipants 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. |
| Resource List | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Housing Prescription | Behavioural | Housing Prescription |
Primary outcome
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.
7 secondary outcomes
Emergency Department utilization
Time frame: baseline, six months, twelve months, 18 months, 24 months
Adherence to well-child visits schedule
Time frame: one year, two years
Adherence to immunization schedule
Time frame: one year, two years
Caregiver mental health
Time frame: baseline, six months, twelve months, 18 months, 24 months
Food security
Time frame: baseline, six months, twelve months, 18 months, 24 months
Energy security
Time frame: baseline, six months, twelve months, 18 months, 24 months
Health care hardships
Time frame: baseline, six months, twelve months, 18 months, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Background: PubMed 21680929Cutts DB, Meyers AF, Black MM, Casey PH, Chilton M, Cook JT, Geppert J, Ettinger de Cuba S, Heeren T, Coleman S, Rose-Jacobs R, Frank DA. US Housing insecurity and the health of very young children. Am J Public Health. 2011 Aug;101(8):1508-14. doi: 10.2105/AJPH.2011.300139. Epub 2011 Jun 16.
- Children's HealthWatch report on behind on rentLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Sandel, MD, MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Housing Prescription in people with Housing Instability and High Emergency Department Utilization, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in housing stability (time frame: baseline, six months, twelve months, 18 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.