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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02895295
Acronym
CHOICE
Enrollment
1185
Registered
2016-09-09
Start date
2016-09-10
Completion date
2017-01-20
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prescription Drug Insurance Decision Making

Keywords

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

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.

Interventions

BEHAVIORALExpert Recommendation

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

BEHAVIORALIndividual Analysis

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

BEHAVIORALUsual 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.

Sponsors

Palo Alto Medical Foundation
CollaboratorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
66 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Count of Participants Whose 2017 Plan Differed From Their 2016 Planwithin 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.
Decisional Conflictwithin 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.
Satisfaction With the Choice Processwithin 50 days of the end of the open enrollment periodResponse 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 Spendingwithin 50 days of the end of the open enrollment periodChange 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.

Participant flow

Participants by arm

ArmCount
Control
Usual Care: Study subjects randomized to the control arm received access to information on resources available in the community to help them choose a prescription drug plan and on how to download their prescription drug information from their electronic medical record.
313
Expert Recommendation
Study subjects randomized to the Expert Recommendation arm received access to a decision support tool that provided personalized, expert recommendations of particular plans as well as personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction).
316
Individual Analysis
Study subjects randomized to the Individual Analysis arm received access to a decision support tool that provided personalized information on the financial implications of enrolling in different plans, including plan premiums and spending on prescription drugs, and the Medicare star ratings (a measure of average customer satisfaction).
299
Total928

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudySurvey Non-response719492

Baseline characteristics

CharacteristicControlExpert RecommendationIndividual AnalysisTotal
Age, Continuous72.68 years
STANDARD_DEVIATION 4.64
72.03 years
STANDARD_DEVIATION 4.55
72.11 years
STANDARD_DEVIATION 4.5
72.68 years
STANDARD_DEVIATION 4.64
Estimated prescription drug spending1496.80 US dollars
STANDARD_DEVIATION 1689.97
1701.38 US dollars
STANDARD_DEVIATION 2068.86
1580.56 US dollars
STANDARD_DEVIATION 1493.58
1593.44 US dollars
STANDARD_DEVIATION 1771.73
Race/Ethnicity, Customized
Asian
35 Participants17 Participants18 Participants70 Participants
Race/Ethnicity, Customized
Black
0 Participants1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Hispanic
7 Participants3 Participants6 Participants16 Participants
Race/Ethnicity, Customized
Other or missing
28 Participants33 Participants34 Participants95 Participants
Race/Ethnicity, Customized
White
243 Participants262 Participants240 Participants745 Participants
Sex: Female, Male
Female
166 Participants150 Participants150 Participants466 Participants
Sex: Female, Male
Male
147 Participants166 Participants149 Participants462 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

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.

Time frame: within 50 days of the end of the open enrollment period

Population: Study participants who responded to questions about their 2017 plan choice in the final survey administered after open enrollment had ended.

ArmMeasureValue (MEAN)Dispersion
ControlChange in Estimated Prescription Drug Spending-178.90 US dollarsStandard Deviation 1029.93
Expert RecommendationChange in Estimated Prescription Drug Spending-249.59 US dollarsStandard Deviation 899.81
Individual AnalysisChange in Estimated Prescription Drug Spending-197.29 US dollarsStandard Deviation 599.38
Primary

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.

Time frame: within 50 days of the end of the open enrollment period.

Population: Set of participants who responded to questions about plan enrollment in the final survey.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlCount of Participants Whose 2017 Plan Differed From Their 2016 Plan85 Participants
Expert RecommendationCount of Participants Whose 2017 Plan Differed From Their 2016 Plan110 Participants
Individual AnalysisCount of Participants Whose 2017 Plan Differed From Their 2016 Plan86 Participants
Primary

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.

Time frame: within 50 days of the end of the open enrollment period.

Population: Study participants who responded to decisional conflict questions on the final survey.

ArmMeasureValue (MEAN)Dispersion
ControlDecisional Conflict21.06 units on a scaleStandard Deviation 22.56
Expert RecommendationDecisional Conflict20.86 units on a scaleStandard Deviation 21.99
Individual AnalysisDecisional Conflict19.56 units on a scaleStandard Deviation 22.14
Primary

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.

Time frame: within 50 days of the end of the open enrollment period

Population: Study participants who responded to question about satisfaction with the choice process on the final survey

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlSatisfaction With the Choice Process122 Participants
Expert RecommendationSatisfaction With the Choice Process148 Participants
Individual AnalysisSatisfaction With the Choice Process134 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026