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

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ClinicalTrials.gov Identifier: NCT02895295
Recruitment Status : Completed
First Posted : September 9, 2016
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Palo Alto Medical Foundation
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
M. Kate Bundorf, Stanford University

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.

Condition or disease Intervention/treatment Phase
Prescription Drug Insurance Decision Making Behavioral: Expert Recommendation Behavioral: Individual Analysis Behavioral: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Actual Study Start Date : September 10, 2016
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicare

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Study Documents (Full-Text)

Documents provided by M. Kate Bundorf, Stanford University:
Publications:
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Responsible Party: M. Kate Bundorf, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02895295    
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 )
First Posted: September 9, 2016    Key Record Dates
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019
Last Verified: July 2019
Keywords provided by M. Kate Bundorf, Stanford University:
Medicare Part D
decision support
prescription drugs
expert recommendation
health insurance choice