Health Care UtilizationNCT05622903
Effect of Cash Benefits on Health Care Utilization
A study testing Cash Benefit and No Cash Benefit in people with Health Care Utilization, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- What is being tested?
- Cash Benefit and No Cash Benefit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,615 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 1 Feb 2024
- 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
- Resident of Chelsea, Massachusetts
- Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income
Who cannot join
- See inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Health Care Utilization
- Being tested
- Cash Benefit, No Cash Benefit
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash BenefitOther
Also called Basic Income, Debit Card
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.
No Cash BenefitOther
No monthly cash benefit.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants in the treatment group received up to $400 per month. Receives: Other: Cash Benefit |
| Control Group | Active comparator | Participants in the control group did not receive monthly cash benefits. Receives: Other: No Cash Benefit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency department use
Count of visits to the emergency department (ED) using the electronic health record
Measured: 10 months
Secondary outcomes (10)
Behavioral health-related ED visit
Visits to the ED with a behavioral health-related diagnosis code
Measured: 10 months
Substance use disorder-related ED visit
Visits to the ED with a substance use disorder-related diagnosis code
Measured: 10 months
Potentially avoidable ED visit
Visits to the ED that are potentially avoidable, categorized as avoidable according to the previously validated New York University algorithm
Measured: 10 months
ED visit resulting in admission to the hospital
Visits to the ED that result in a hospitalization
Measured: 10 months
Outpatient service use
Office visits and visits for other types of outpatient care such as imaging and procedures
Measured: 10 months
COVID vaccination
Binary variable for having received at least one dose of any COVID vaccine by the end of the trial period
Measured: 10 months
Hemoglobin A1c
Continuous measure of diabetes, using the latest available reading or result during trial period
Measured: 10 months
Blood pressure
Continuous measure of blood pressure, using the latest available reading or result during trial period
Measured: 10 months
Weight
Continuous measure of weight, using the latest available reading or result during trial period
Measured: 10 months
Cholesterol
Continuous measure of cholesterol, using the latest available reading or result during trial period
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start27 Jul 2020
- Primary completion31 Dec 2021
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Cambridge Health Alliance
- Responsible party
- Principal investigator, Sumit Agarwal, Harvard Medical School (HMS and HSDM)
- Investigators
- Sumit Agarwal, MD, MPH, Principal investigator, Brigham and Women's Hospital and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622903
- Sponsor's protocol ID
- 2022P000093
- Status last verified
- Jul 2024
- First submitted
- 14 Nov 2022
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cash Benefits on Health Care Utilization
- ClinicalTrials.gov ID
- NCT05622903
- Acronym / sponsor ID
- 2022P000093
- Conditions
- Health Care Utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,615 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Cambridge Health Alliance
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Cash BenefitParticipants in the treatment group received up to $400 per month. |
| Control Group | Active comparator | Other: No Cash BenefitParticipants in the control group did not receive monthly cash benefits. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Resident of Chelsea, Massachusetts
- Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income
Key exclusion criteria (1 listed)
- See inclusion criteria
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 |
|---|---|---|
| Cash BenefitAlso: Basic Income, Debit CardSpending 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 | Treatment Group |
| No Cash BenefitNo monthly cash benefit. | Other | Control Group |
Primary outcome
Emergency department use
Time frame: 10 months
Count of visits to the emergency department (ED) using the electronic health record
10 secondary outcomes
Behavioral health-related ED visit
Time frame: 10 months
Substance use disorder-related ED visit
Time frame: 10 months
Potentially avoidable ED visit
Time frame: 10 months
ED visit resulting in admission to the hospital
Time frame: 10 months
Outpatient service use
Time frame: 10 months
COVID vaccination
Time frame: 10 months
Hemoglobin A1c
Time frame: 10 months
Blood pressure
Time frame: 10 months
Weight
Time frame: 10 months
Cholesterol
Time frame: 10 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 12 Jul 2024.
- 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.
Sumit Agarwal, MD, MPH principal investigator
Brigham and Women's Hospital and Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash Benefit and No Cash Benefit in people with Health Care Utilization, run by Harvard Medical School (HMS and HSDM) 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 2 inclusion and 1 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 12 Jul 2024. 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?
Emergency department use (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2024.