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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02895295
• Collaborator: Palo Alto Medical Foundation (Other), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 1,185
• Arms: 3
• Actual Duration (Months): 4.3

Study Details

Study Description

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	N/A

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.

Study Design

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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Count of Participants Whose 2017 Plan Differed From Their 2016 Plan [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 66 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 23, 2016

More Information

Publications

• 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.

• Responsible Party: M. Kate Bundorf, Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02895295
• Other Study ID Numbers: IRB-38241; CDR-1306-03598; 2016.107EXP
• First Posted: Sep 9, 2016
• Last Update Posted: Jul 23, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by M. Kate Bundorf, Associate Professor, Stanford University: Medicare Part D; decision support; prescription drugs; expert recommendation; health insurance choice

Study Results

Participant Flow

Arm/Group Title	Control	Expert Recommendation	Individual Analysis
Arm/Group Description	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. 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.	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). Expert Recommendation: Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.	Participants randomized to "Individual Analysis" arm will receive will receive access to a decision support tool that provides individualized cost information for each plan but not the expert scores for particular plans. Individual Analysis: Decision support tool that provides personalized information on the financial implications of enrolling in different plans.
Period Title: Overall Study
STARTED	384	410	391
COMPLETED	313	316	299
NOT COMPLETED	71	94	92

Baseline Characteristics

Arm/Group Title	Control	Expert Recommendation	Individual Analysis	Total
Arm/Group Description	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.	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).	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).	Total of all reporting groups
Overall Participants	313	316	299	928
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.68 (4.64)	72.03 (4.55)	72.11 (4.50)	72.68 (4.64)
Sex: Female, Male (Count of Participants)
Female	166 53%	150 47.5%	150 50.2%	466 50.2%
Male	147 47%	166 52.5%	149 49.8%	462 49.8%
Race/Ethnicity, Customized (Count of Participants)
White	243 77.6%	262 82.9%	240 80.3%	745 80.3%
Asian	35 11.2%	17 5.4%	18 6%	70 7.5%
Hispanic	7 2.2%	3 0.9%	6 2%	16 1.7%
Black	0 0%	1 0.3%	1 0.3%	2 0.2%
Other or missing	28 8.9%	33 10.4%	34 11.4%	95 10.2%
Estimated prescription drug spending (US dollars) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [US dollars]	1496.80 (1689.97)	1701.38 (2068.86)	1580.56 (1493.58)	1593.44 (1771.73)

Outcome Measures

1. Primary Outcome

Title	Count of Participants Whose 2017 Plan Differed From Their 2016 Plan
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control	Expert Recommendation	Individual Analysis
Arm/Group Description	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.	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).	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).
Measure Participants	301	305	290
Count of Participants [Participants]	85 27.2%	110 34.8%	86 28.8%

2. Primary Outcome

Title	Decisional Conflict
Description	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.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control	Expert Recommendation	Individual Analysis
Arm/Group Description	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.	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).	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).
Measure Participants	302	296	285
Mean (Standard Deviation) [units on a scale]	21.06 (22.56)	20.86 (21.99)	19.56 (22.14)

3. Primary Outcome

Title	Satisfaction With the Choice Process
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control	Expert Recommendation	Individual Analysis
Arm/Group Description	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.	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).	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).
Measure Participants	313	316	299
Count of Participants [Participants]	122 39%	148 46.8%	134 44.8%

4. Primary Outcome

Title	Change in Estimated Prescription Drug Spending
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control	Expert Recommendation	Individual Analysis
Arm/Group Description	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.	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).	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).
Measure Participants	301	305	290
Mean (Standard Deviation) [US dollars]	-178.90 (1029.93)	-249.59 (899.81)	-197.29 (599.38)

Adverse Events

Time Frame	Data were not collected for adverse events or all-cause mortality in this study.
Adverse Event Reporting Description	Data were not collected for adverse events or all-cause mortality in this study.
Arm/Group Title	Control		Expert Recommendation		Individual Analysis
Arm/Group Description	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.		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).		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).
All Cause Mortality
	Control		Expert Recommendation		Individual Analysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Control		Expert Recommendation		Individual Analysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Control		Expert Recommendation		Individual Analysis
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.