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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03715907
Other study ID # 1805348624
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2018
Est. completion date June 30, 2021

Study information

Verified date September 2021
Source Massachusetts Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8042
Est. completion date June 30, 2021
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial Incentives
Incentives for gap closure.
Information
Information on care gap and closure process.

Locations

Country Name City State
United States Massachusetts Institute of Technology Cambridge Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months, from the date of randomization until end-of-year (i.e., December 31, 2018)
Primary 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. 18 months, from the date of randomization until December 31, 2019
Secondary Health care expenditure during study - Total claims (dollars) 6 months, from the date of randomization until end-of-year
Secondary Health care expenditure following study - Total claims Total claims (dollars) 12 months, from December 31 2018 - December 31 2019
Secondary Outpatient visits during study Number of outpatient visits 6 months, from the date of randomization until end-of-year
Secondary Outpatient visits following study Number of outpatient visits 12 months, from December 31 2018 - December 31 2019
Secondary Inpatient visits during study Number of inpatient visits 6 months, from the date of randomization until end-of-year
Secondary Inpatient visits following study Number of inpatient visits 12 months, from December 31 2018 - December 31 2019
Secondary Prescriptions during study Number of prescriptions 6 months, from the date of randomization until end-of-year
Secondary Prescriptions following study Number of prescriptions 12 months, from December 31 2018 - December 31 2019
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