Evaluating a Patient-Centered Tool to Help Medicare Beneficiaries Choose Prescription Drug Plans

NCT ID: NCT02895295

Last Updated: 2019-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-10

Study Completion Date

2017-01-20

Brief Summary

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The objective of this study is to determine whether providing Medicare beneficiaries with a web-based patient-centered decision tool to help them choose among prescription medication coverage plans improves outcomes for patients including a greater likelihood of changing a plan, better coverage for prescribed drugs, less decisional conflict when choosing plans, and greater satisfaction with the choice process relative to current practice.

Detailed Description

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In this study, the investigators tested the effectiveness of two versions of a web-based tool (called CHOICE) to help people choose among Medicare Part D plans (Treatments A and B) relative to standard care (Control). Both treatment arms incorporated simplified design and automated importation of an individual's prescription drugs relative to standard care. The treatment arms varied based on whether they provided expert guidance on recommended plans. In the control arm, study participants were directed to the existing, publicly available Medicare.gov website and received instructions on how to download their drugs from the Palo Alto Medical Foundation (PAMF) patient-facing online personal health portal (myhealthonline). The study sample included PAMF patients who were enrolled in Part D plans (not Medicare Advantage) during the 2016 enrollment period. Prior to the 2017 open enrollment period (October 15 to December 7, 2016), we invited a subset of PAMF patients not covered by either MediCal or a Medicare Advantage plan, aged 66-85, residing in 4 counties served by PAMF, and with at least one active medication order to participate in a study examining the effectiveness of decision tools that provide personalized information on the financial implications of enrolling in different Part D plans. The primary study outcomes included 1) Plan switching, 2) Decisional conflict 3) Satisfaction with the choice process, and 4) Change in generosity of coverage of prescription drugs. The investigators measured the primary study outcomes using a combination of administrative data and a post open enrollment survey. The investigators also collected information on individual characteristics at the time of enrollment in the study and implemented a survey examining use of the intervention tool to assess patient experience at the time of use.

Conditions

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Prescription Drug Insurance Decision Making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Study subjects randomized to the control arm will receive information on how to download their prescription drug information from their electronic medical record and will be provided with a list of resources available in the community to help them choose a prescription drug plan.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Study subjects randomized to the control arm will receive information on how to download their prescription drug information from their electronic medical record and provided with a list of resources available in the community to help them choose a prescription drug plan.

Expert Recommendation

Participants randomized to the "Expert Recommendation" arm will receive access to a decision support tool that provides personalized expert scores for particular plans based on individual's likely annual out-of-pocket spending, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of customer satisfaction).

Group Type EXPERIMENTAL

Expert Recommendation

Intervention Type BEHAVIORAL

Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.

Individual Analysis

Participants randomized to "Individual Analysis" arm will receive access to a decision support tool that provides individualized cost information for each plan but not the expert scores for particular plans.

Group Type ACTIVE_COMPARATOR

Individual Analysis

Intervention Type BEHAVIORAL

Decision support tool that provides personalized information on the financial implications of enrolling in different plans.

Interventions

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Expert Recommendation

Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.

Intervention Type BEHAVIORAL

Individual Analysis

Decision support tool that provides personalized information on the financial implications of enrolling in different plans.

Intervention Type BEHAVIORAL

Usual Care

Study subjects randomized to the control arm will receive information on how to download their prescription drug information from their electronic medical record and provided with a list of resources available in the community to help them choose a prescription drug plan.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The study population included Medicare beneficiaries who received care from the Palo Alto Medical Foundation, a large multi-specialty group in the San Francisco Bay Area ages 66-85, one per household enrolled in a Medicare Part D plan in 2016.

Exclusion Criteria

* Enrolled in a Medicare Advantage Plan and/or MediCal
Minimum Eligible Age

66 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palo Alto Medical Foundation

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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M. Kate Bundorf

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Linder SK, Swank PR, Vernon SW, Mullen PD, Morgan RO, Volk RJ. Validity of a low literacy version of the Decisional Conflict Scale. Patient Educ Couns. 2011 Dec;85(3):521-4. doi: 10.1016/j.pec.2010.12.012. Epub 2011 Feb 5.

Reference Type BACKGROUND
PMID: 21300518 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CDR-1306-03598

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2016.107EXP

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-38241

Identifier Type: -

Identifier Source: org_study_id

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