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

NCT02895295 | Completed Results

• 3 other identifiers: IRB-38241CDR-1306-035982016.107EXP
• Study Type: interventional
• Target: 1,185
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prescription Drug Insurance Decision Making

Keywords

Medicare Part D; decision support; prescription drugs; expert recommendation; health insurance choice

Outcome Measures

Primary Outcomes (4)

• Count of Participants Whose 2017 Plan Differed From Their 2016 Plan

  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

  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

  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

  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

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Expert Recommendation

EXPERIMENTAL

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

Individual Analysis

ACTIVE COMPARATOR

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

Interventions

Expert Recommendation BEHAVIORAL

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

Expert Recommendation

Individual Analysis BEHAVIORAL

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

Individual Analysis

Usual Care 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.

Control

Eligibility Criteria

• Age: 66 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Enrolled in a Medicare Advantage Plan and/or MediCal

Sponsors & Collaborators

• Stanford University: lead
• Palo Alto Medical Foundation: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Related Publications (1)

• 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.

  PMID: 21300518 BACKGROUND

Results Point of Contact

• Title: Dr. M. Kate Bundorf
• Organization: Stanford University

bundorf@stanford.edu

6507250067

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 9, 2016
• Study Start: September 10, 2016
• Primary Completion: January 20, 2017
• Study Completion: January 20, 2017
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-07