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Clinical Trials/NCT02895295
NCT02895295
Completed
Not Applicable

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

Stanford University0 sites1,185 target enrollmentSeptember 10, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prescription Drug Insurance Decision Making
Sponsor
Stanford University
Enrollment
1185
Primary Endpoint
Decisional Conflict
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2016
End Date
January 20, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

M. Kate Bundorf

Associate Professor

Stanford University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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