Delivery of Health CareNCT03715907
Financial Incentives for Care Gaps
A study testing Financial Incentives and Information in people with Delivery of Health Care, run by Massachusetts Institute of Technology at 1 site in United States.
Trial summary
This project seeks to understand how individuals respond to financial incentive programs for wellness care. In a randomized controlled trial among customers with care gaps, the investigators will experimentally compare the impacts of incentives for gap closure (gift cards), information on existing gaps (mailers), and… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delivery of Health Care
- What is being tested?
- Financial Incentives and Information
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,042 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 30 Jun 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a partner organization member in the region of study
- Has a care gap in one of the six target areas
Who cannot join
- Participating in another select high-intensity wellness intervention provided by the partner organization
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
About this study
Official title: Financial Incentives for Care Gaps: A Randomized Controlled Trial
This project seeks to understand how individuals respond to financial incentive programs for wellness care. In a randomized controlled trial among customers with care gaps, the investigators will experimentally compare the impacts of incentives for gap closure (gift cards), information on existing gaps (mailers), and no intervention. The research objectives are to assess how responsive individuals are to incentives for, and to information about, existing care gaps; and to assess spillovers from incentives onto other care. In addition, impacts on downstream utilization will be studied, which may be impacted if financial incentives are effective at increasing wellness visits.
Read the detailed description
Setting and sample:
The study will be conducted among individuals enrolled in an insurance plan offered by an insurance company in the state of Nebraska.
The sample will include a subset of individuals eligible for a program designed to improve delivery of care by incentivizing individuals and their dependents to fill "care gaps" - gaps in recommended care.
Interventions:
The design will entail two overarching interventions for each incentivized care gap: Incentives, and Information Only. In addition, there will be a control that receives neither.
- Incentives. Individuals receiving the Incentives intervention for a given care gap will receive a mailer informing them of that gap, and that they are eligible for a gift card if they close that care gap.
- Information Only. Individuals receiving the Information Only intervention for a given care gap will receive a mailer informing them of that gap, but without information on the incentives available.
- Control. Individuals receiving the Control intervention for a given care gap will not receive a mailer.
All individuals will be made whole following the intervention period, regardless of treatment status; i.e. members will be compensated for closing incentivized care gaps regardless of whether they were informed of their eligibility to do so.
The specific Incentivized Care Gaps include: W34, LSC, IMA, CDC Eye Exam and/or CDC Hba1c Screening, CCS, and AWC.
Randomization:
A separate letter is sent for each care gap, so that individuals may receive more than one letter. The investigators will randomize which letters are sent.
The process will be as follows: every individual with a care gap in the sample (a care-gap, beneficiary pair) will be randomly assigned a study status: financial incentive, information only, or no letter. When it comes time to send mailers for each care gap, mailers will be sent according to the intersection of eligibility and care gap-specific treatment assignment. E.g. if at mailing time a participant is eligible for only cervical cancer screening (CCS), that participant will receive the CCS intervention (Control, Information Only, or Incentives) as pre-assigned. If the participant is also eligible for an adolescent well-visit (AWC) incentive based on her dependent's age and visit status, the participant will also receive the AWC intervention as pre-assigned; this intervention may be the same or different from her CCS intervention.
Analysis:
The investigators will compare the number and rate of care-gap closure at 6 and 18 months following the initial mailing. The investigators will also conduct heterogeneity analysis according to baseline characteristics of the population.
- Conditions
- Delivery of Health Care
- Being tested
- Financial Incentives, Information
- Keywords
- Professional Practice Gaps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentivesBehavioural
Incentives for gap closure.
InformationBehavioural
Information on care gap and closure process.
| Study group | Role | What they receive |
|---|---|---|
| Control: W34 | No intervention | Members receiving the Control intervention for the W34 (3- to 6-year-old well visit) gap will not receive a mailer. |
| Information only: W34 | Experimental | Members receiving the Information Only intervention for the W34 care gap will receive a mailer informing them of that gap, but not of financial incentives for closing the care gap. Receives: Behavioral: Information |
| Incentives: W34 | Experimental | Informational W34 mailer and incentive to close gap Receives: Behavioral: Financial Incentives; Behavioral: Information |
| Control: LSC | No intervention | Members receiving the Control intervention for the LSC (lead screening in children) gap will not receive a mailer. |
| Information only: LSC | Experimental | Informational LSC mailer and incentive to close gap Receives: Behavioral: Information |
| Incentives: LSC | Experimental | Members receiving the Incentives intervention for the LSC care gap will receive a mailer informing them of the gap and eligibility for a gift card if they close the gap. Receives: Behavioral: Financial Incentives; Behavioral: Information |
| Control: IMA | No intervention | No mailer for IMA (immunizations) gap |
| Information only: IMA | Experimental | Informational IMA mailer Receives: Behavioral: Information |
| Incentives: IMA | Experimental | Informational IMA mailer and incentive Receives: Behavioral: Financial Incentives; Behavioral: Information |
| Control: CDC | No intervention | No mailer for CDC (clinical diabetes care) gap |
| Information only: CDC | Experimental | Informational CDC mailer Receives: Behavioral: Information |
| Incentives: CDC | Experimental | Informational CDC mailer and incentive Receives: Behavioral: Financial Incentives; Behavioral: Information |
| Control: CCS | No intervention | No mailer for CCS (cervical cancer screening) |
| Information only: CCS | Experimental | Informational CCS mailer Receives: Behavioral: Information |
| Incentives: CCS | Experimental | Informational CCS mailer and incentive Receives: Behavioral: Financial Incentives; Behavioral: Information |
| Control: AWC | No intervention | No mailer for AWC (adolescent well-care visit) gap |
| Information only: AWC | Experimental | Informational AWC mailer Receives: Behavioral: Information |
| Incentives: AWC | Experimental | Informational AWC mailer and incentive Receives: Behavioral: Financial Incentives; Behavioral: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of care gaps closed
Care gap closure for all care gaps. A care gap is considered closed for an individual or dependent who had not received recommended care (i.e. who had a care gap) at the time of enrollment at the time they receive the recommended care. For example, if a dependent child has not received lead screening (LSC) at the time of enrollment, the LSC care gap is considered closed once the child receives a lead screening.
Measured: 6 months, from the date of randomization until end-of-year (i.e., December 31, 2018)
Proportion of care gaps closed
Care gap closure for all care gaps. A care gap is considered closed for an individual or dependent who had not received recommended care (i.e. who had a care gap) at the time of enrollment at the time they receive the recommended care. For example, if a dependent child has not received lead screening (LSC) at the time of enrollment, the LSC care gap is considered closed once the child receives a lead screening.
Measured: 18 months, from the date of randomization until December 31, 2019
Secondary outcomes (8)
Health care expenditure during study - Total claims
(dollars)
Measured: 6 months, from the date of randomization until end-of-year
Health care expenditure following study - Total claims
Total claims (dollars)
Measured: 12 months, from December 31 2018 - December 31 2019
Outpatient visits during study
Number of outpatient visits
Measured: 6 months, from the date of randomization until end-of-year
Outpatient visits following study
Number of outpatient visits
Measured: 12 months, from December 31 2018 - December 31 2019
Inpatient visits during study
Number of inpatient visits
Measured: 6 months, from the date of randomization until end-of-year
Inpatient visits following study
Number of inpatient visits
Measured: 12 months, from December 31 2018 - December 31 2019
Prescriptions during study
Number of prescriptions
Measured: 6 months, from the date of randomization until end-of-year
Prescriptions following study
Number of prescriptions
Measured: 12 months, from December 31 2018 - December 31 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start31 Aug 2018
- Primary completion31 Dec 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery of Health CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715907
- Sponsor's protocol ID
- 1805348624
- Status last verified
- Sep 2021
- First submitted
- 11 Oct 2018
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives for Care Gaps: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03715907
- Acronym / sponsor ID
- 1805348624
- Conditions
- Delivery of Health Care
- Keywords
- Professional Practice Gaps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,042 participants (actual)
- Lead sponsor
- Massachusetts Institute of TechnologyUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 23 Oct 2018 (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.
This project seeks to understand how individuals respond to financial incentive programs for wellness care. In a randomized controlled trial among customers with care gaps, the investigators will experimentally compare the impacts of incentives for gap closure (gift cards), information on existing gaps (mailers), and no intervention. The research objectives are to assess how responsive individuals are to incentives for, and to information about, existing care gaps; and to assess spillovers from incentives onto other care. In addition, impacts on downstream utilization will be studied, which may be impacted if financial incentives are effective at increasing wellness visits.
Detailed description
Setting and sample:
The study will be conducted among individuals enrolled in an insurance plan offered by an insurance company in the state of Nebraska.
The sample will include a subset of individuals eligible for a program designed to improve delivery of care by incentivizing individuals and their dependents to fill "care gaps" - gaps in recommended care.
Interventions:
The design will entail two overarching interventions for each incentivized care gap: Incentives, and Information Only. In addition, there will be a control that receives neither.
- Incentives. Individuals receiving the Incentives intervention for a given care gap will receive a mailer informing them of that gap, and that they are eligible for a gift card if they close that care gap.
- Information Only. Individuals receiving the Information Only intervention for a given care gap will receive a mailer informing them of that gap, but without information on the incentives available.
- Control. Individuals receiving the Control intervention for a given care gap will not receive a mailer.
All individuals will be made whole following the intervention period, regardless of treatment status; i.e. members will be compensated for closing incentivized care gaps regardless of whether they were informed of their eligibility to do so.
The specific Incentivized Care Gaps include: W34, LSC, IMA, CDC Eye Exam and/or CDC Hba1c Screening, CCS, and AWC.
Randomization:
A separate letter is sent for each care gap, so that individuals may receive more than one letter. The investigators will randomize which letters are sent.
The process will be as follows: every individual with a care gap in the sample (a care-gap, beneficiary pair) will be randomly assigned a study status: financial incentive, information only, or no letter. When it comes time to send mailers for each care gap, mailers will be sent according to the intersection of eligibility and care gap-specific treatment assignment. E.g. if at mailing time a participant is eligible for only cervical cancer screening (CCS), that participant will receive the CCS intervention (Control, Information Only, or Incentives) as pre-assigned. If the participant is also eligible for an adolescent well-visit (AWC) incentive based on her dependent's age and visit status, the participant will also receive the AWC intervention as pre-assigned; this intervention may be the same or different from her CCS intervention.
Analysis:
The investigators will compare the number and rate of care-gap closure at 6 and 18 months following the initial mailing. The investigators will also conduct heterogeneity analysis according to baseline characteristics of the population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Control: W34 | No intervention | –Members receiving the Control intervention for the W34 (3- to 6-year-old well visit) gap will not receive a mailer. |
| Information only: W34 | Experimental | Behavioral: InformationMembers receiving the Information Only intervention for the W34 care gap will receive a mailer informing them of that gap, but not of financial incentives for closing the care gap. |
| Incentives: W34 | Experimental | Behavioral: Financial Incentives, Behavioral: InformationInformational W34 mailer and incentive to close gap |
| Control: LSC | No intervention | –Members receiving the Control intervention for the LSC (lead screening in children) gap will not receive a mailer. |
| Information only: LSC | Experimental | Behavioral: InformationInformational LSC mailer and incentive to close gap |
| Incentives: LSC | Experimental | Behavioral: Financial Incentives, Behavioral: InformationMembers receiving the Incentives intervention for the LSC care gap will receive a mailer informing them of the gap and eligibility for a gift card if they close the gap. |
| Control: IMA | No intervention | –No mailer for IMA (immunizations) gap |
| Information only: IMA | Experimental | Behavioral: InformationInformational IMA mailer |
| Incentives: IMA | Experimental | Behavioral: Financial Incentives, Behavioral: InformationInformational IMA mailer and incentive |
| Control: CDC | No intervention | –No mailer for CDC (clinical diabetes care) gap |
| Information only: CDC | Experimental | Behavioral: InformationInformational CDC mailer |
| Incentives: CDC | Experimental | Behavioral: Financial Incentives, Behavioral: InformationInformational CDC mailer and incentive |
| Control: CCS | No intervention | –No mailer for CCS (cervical cancer screening) |
| Information only: CCS | Experimental | Behavioral: InformationInformational CCS mailer |
| Incentives: CCS | Experimental | Behavioral: Financial Incentives, Behavioral: InformationInformational CCS mailer and incentive |
| Control: AWC | No intervention | –No mailer for AWC (adolescent well-care visit) gap |
| Information only: AWC | Experimental | Behavioral: InformationInformational AWC mailer |
| Incentives: AWC | Experimental | Behavioral: Financial Incentives, Behavioral: InformationInformational AWC mailer and incentive |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is a partner organization member in the region of study
- Has a care gap in one of the six target areas
Key exclusion criteria (1 listed)
- Participating in another select high-intensity wellness intervention provided by the partner organization
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 |
|---|---|---|
| Financial IncentivesIncentives for gap closure. | Behavioural | Incentives: AWC, Incentives: CCS, Incentives: CDC, Incentives: IMA, Incentives: LSC, Incentives: W34 |
| InformationInformation on care gap and closure process. | Behavioural | Incentives: AWC, Incentives: CCS, Incentives: CDC, Incentives: IMA, Incentives: LSC, Incentives: W34, Information only: AWC, Information only: CCS, Information only: CDC, Information only: IMA, Information only: LSC, Information only: W34 |
Primary outcome
Proportion of care gaps closed
Time frame: 6 months, from the date of randomization until end-of-year (i.e., December 31, 2018)
Care gap closure for all care gaps. A care gap is considered closed for an individual or dependent who had not received recommended care (i.e. who had a care gap) at the time of enrollment at the time they receive the recommended care. For example, if a dependent child has not received lead screening (LSC) at the time of enrollment, the LSC care gap is considered closed once the child receives a lead screening.
Proportion of care gaps closed
Time frame: 18 months, from the date of randomization until December 31, 2019
Care gap closure for all care gaps. A care gap is considered closed for an individual or dependent who had not received recommended care (i.e. who had a care gap) at the time of enrollment at the time they receive the recommended care. For example, if a dependent child has not received lead screening (LSC) at the time of enrollment, the LSC care gap is considered closed once the child receives a lead screening.
8 secondary outcomes
Health care expenditure during study - Total claims
Time frame: 6 months, from the date of randomization until end-of-year
Health care expenditure following study - Total claims
Time frame: 12 months, from December 31 2018 - December 31 2019
Outpatient visits during study
Time frame: 6 months, from the date of randomization until end-of-year
Outpatient visits following study
Time frame: 12 months, from December 31 2018 - December 31 2019
Inpatient visits during study
Time frame: 6 months, from the date of randomization until end-of-year
Inpatient visits following study
Time frame: 12 months, from December 31 2018 - December 31 2019
Prescriptions during study
Time frame: 6 months, from the date of randomization until end-of-year
Prescriptions following study
Time frame: 12 months, from December 31 2018 - December 31 2019
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 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives and Information in people with Delivery of Health Care, run by Massachusetts Institute of Technology 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 6 Oct 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?
Proportion of care gaps closed (time frame: 6 months, from the date of randomization until end-of-year (i.e., December 31, 2018)). The study lists 2 primary outcomes in all. 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 6 Oct 2021.