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

July 18, 2019 updated by: M. Kate Bundorf, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1185

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: 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).
Behavioral: Expert Recommendation
Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.
Active Comparator: 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.
Behavioral: Individual Analysis
Decision support tool that provides personalized information on the financial implications of enrolling in different plans.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of Participants Whose 2017 Plan Differed From Their 2016 Plan
Time Frame: within 50 days of the end of the open enrollment period.
Indicator of whether the self-reported plan of the participant differed before and after open enrollment and the participant reported that s/he changed plans during open enrollment.
within 50 days of the end of the open enrollment period.
Decisional Conflict
Time Frame: within 50 days of the end of the open enrollment period.
Low literacy decisional conflict scale (Linder et al., 2011), edited slightly for context of health insurance rather than treatment choice. The scale has 4 subscales (uncertainty, informed, values clarity and support) with 2 to 3 questions per subscale. Respondents can indicate "yes", "no", or "unsure" for each item. An answer of "yes" receives 0, "unsure" receives 2 and "no" receives 4 points. The sum of the responses to each question within a subscale is normalized to a scale of 25. The subscales are then summed to a total score ranging from 0 to 100 where 0 represents the lowest level of decisional conflict and 100 represents the highest level of decisional conflict.
within 50 days of the end of the open enrollment period.
Satisfaction With the Choice Process
Time Frame: within 50 days of the end of the open enrollment period
Response to the question of, "How satisfied are you with the process of choosing a plan?" with 4 potential responses: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied. The count of participants who responded "very satisfied" is reported.
within 50 days of the end of the open enrollment period
Change in Estimated Prescription Drug Spending
Time Frame: within 50 days of the end of the open enrollment period
Change in estimated prescription drug spending is the difference in estimated spending in US dollars, including both premiums and out-of-pocket spending on prescription drugs, between the participant's 2016 and 2017 plans based on their initial drug list.
within 50 days of the end of the open enrollment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Patient-Centered Outcomes Research Institute
Palo Alto Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2016

Primary Completion (Actual)

January 20, 2017

Study Completion (Actual)

January 20, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-38241
  • CDR-1306-03598 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)
  • 2016.107EXP (Other Identifier: Sutter Health Institutional Review Board)

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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