- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03715907
Financial Incentives for Care Gaps
Financial Incentives for Care Gaps: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Cambridge, Massachusetts, United States, 02139
- Massachusetts Institute of Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Is a partner organization member in the region of study
- Has a care gap in one of the six target areas
Exclusion Criteria:
- Participating in another select high-intensity wellness intervention provided by the partner organization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control: W34
Members receiving the Control intervention for the W34 (3- to 6-year-old well visit) gap will not receive a mailer.
|
|
Experimental: Information only: W34
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.
|
Information on care gap and closure process.
|
Experimental: Incentives: W34
Informational W34 mailer and incentive to close gap
|
Information on care gap and closure process.
Incentives for gap closure.
|
No Intervention: Control: LSC
Members receiving the Control intervention for the LSC (lead screening in children) gap will not receive a mailer.
|
|
Experimental: Information only: LSC
Informational LSC mailer and incentive to close gap
|
Information on care gap and closure process.
|
Experimental: Incentives: LSC
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.
|
Information on care gap and closure process.
Incentives for gap closure.
|
No Intervention: Control: IMA
No mailer for IMA (immunizations) gap
|
|
Experimental: Information only: IMA
Informational IMA mailer
|
Information on care gap and closure process.
|
Experimental: Incentives: IMA
Informational IMA mailer and incentive
|
Information on care gap and closure process.
Incentives for gap closure.
|
No Intervention: Control: CDC
No mailer for CDC (clinical diabetes care) gap
|
|
Experimental: Information only: CDC
Informational CDC mailer
|
Information on care gap and closure process.
|
Experimental: Incentives: CDC
Informational CDC mailer and incentive
|
Information on care gap and closure process.
Incentives for gap closure.
|
No Intervention: Control: CCS
No mailer for CCS (cervical cancer screening)
|
|
Experimental: Information only: CCS
Informational CCS mailer
|
Information on care gap and closure process.
|
Experimental: Incentives: CCS
Informational CCS mailer and incentive
|
Information on care gap and closure process.
Incentives for gap closure.
|
No Intervention: Control: AWC
No mailer for AWC (adolescent well-care visit) gap
|
|
Experimental: Information only: AWC
Informational AWC mailer
|
Information on care gap and closure process.
|
Experimental: Incentives: AWC
Informational AWC mailer and incentive
|
Information on care gap and closure process.
Incentives for gap closure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months, from the date of randomization until end-of-year (i.e., December 31, 2018)
|
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.
|
18 months, from the date of randomization until December 31, 2019
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health care expenditure during study - Total claims
Time Frame: 6 months, from the date of randomization until end-of-year
|
(dollars)
|
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
|
Total claims (dollars)
|
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
|
Number of outpatient visits
|
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
|
Number of outpatient visits
|
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
|
Number of inpatient visits
|
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
|
Number of inpatient visits
|
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
|
Number of prescriptions
|
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
|
Number of prescriptions
|
12 months, from December 31 2018 - December 31 2019
|
Collaborators and Investigators
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1805348624
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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