- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05622903
Effect of Cash Benefits on Health Care Utilization
July 11, 2024 updated by: Sumit Agarwal, Harvard Medical School (HMS and HSDM)
Using data from the Chelsea Eats program, we propose to study a randomized controlled trial in which the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months during the first two years of the COVID-19 pandemic.
We will analyze the impact of the cash benefit on health care utilization and health.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3615
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Harvard Medical School
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Resident of Chelsea, Massachusetts
- Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income
Exclusion Criteria:
- See inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group
Participants in the treatment group received up to $400 per month.
|
Spending from the cards was not restricted to food but could be spent on anything and anywhere Visa was accepted.
The debit cards were credited with the first payment on November 18th, 2020 and the second payment on December 18th, 2020.
The program continued with monthly credits through August 2021.
Other Names:
|
|
Active Comparator: Control Group
Participants in the control group did not receive monthly cash benefits.
|
No monthly cash benefit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emergency department use
Time Frame: 10 months
|
Count of visits to the emergency department (ED) using the electronic health record
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral health-related ED visit
Time Frame: 10 months
|
Visits to the ED with a behavioral health-related diagnosis code
|
10 months
|
|
Substance use disorder-related ED visit
Time Frame: 10 months
|
Visits to the ED with a substance use disorder-related diagnosis code
|
10 months
|
|
Potentially avoidable ED visit
Time Frame: 10 months
|
Visits to the ED that are potentially avoidable, categorized as avoidable according to the previously validated New York University algorithm
|
10 months
|
|
ED visit resulting in admission to the hospital
Time Frame: 10 months
|
Visits to the ED that result in a hospitalization
|
10 months
|
|
Outpatient service use
Time Frame: 10 months
|
Office visits and visits for other types of outpatient care such as imaging and procedures
|
10 months
|
|
COVID vaccination
Time Frame: 10 months
|
Binary variable for having received at least one dose of any COVID vaccine by the end of the trial period
|
10 months
|
|
Hemoglobin A1c
Time Frame: 10 months
|
Continuous measure of diabetes, using the latest available reading or result during trial period
|
10 months
|
|
Blood pressure
Time Frame: 10 months
|
Continuous measure of blood pressure, using the latest available reading or result during trial period
|
10 months
|
|
Weight
Time Frame: 10 months
|
Continuous measure of weight, using the latest available reading or result during trial period
|
10 months
|
|
Cholesterol
Time Frame: 10 months
|
Continuous measure of cholesterol, using the latest available reading or result during trial period
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sumit Agarwal, MD, MPH, Brigham and Women's Hospital and Harvard Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2020
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
November 14, 2022
First Submitted That Met QC Criteria
November 14, 2022
First Posted (Actual)
November 21, 2022
Study Record Updates
Last Update Posted (Actual)
July 12, 2024
Last Update Submitted That Met QC Criteria
July 11, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2022P000093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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