Clinical trial NCT02895295: Evaluating a Patient-Centered Tool to Help Medicare Beneficiaries Choose Prescription Drug Plans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prescription Drug Insurance Decision Making
Keywords: Medicare Part D
decision support
prescription drugs
expert recommendation
health insurance choice
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Palo Alto Medical Foundation
name: Patient-Centered Outcomes Research Institute
First posted: 2016-09-09
Enrollment: 1185
Sex: ALL
Minimum age (years): 66
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Count of Participants Whose 2017 Plan Differed From Their 2016 Plan
timeFrame: within 50 days of the end of the open enrollment period.
measure: Decisional Conflict
timeFrame: within 50 days of the end of the open enrollment period.
measure: Satisfaction With the Choice Process
timeFrame: within 50 days of the end of the open enrollment period
measure: Change in Estimated Prescription Drug Spending
timeFrame: within 50 days of the end of the open enrollment period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.