Trial Outcomes & Findings for Evaluating a Patient-Centered Tool to Help Medicare Beneficiaries Choose Prescription Drug Plans (NCT NCT02895295)
NCT ID: NCT02895295
Last Updated: 2019-07-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1185 participants
Primary outcome timeframe
within 50 days of the end of the open enrollment period.
Results posted on
2019-07-23
Participant Flow
Participant milestones
| Measure |
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 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.
|
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).
Expert Recommendation: Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.
|
Individual Analysis
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
384
|
410
|
391
|
|
Overall Study
COMPLETED
|
313
|
316
|
299
|
|
Overall Study
NOT COMPLETED
|
71
|
94
|
92
|
Reasons for withdrawal
| Measure |
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 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.
|
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).
Expert Recommendation: Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.
|
Individual Analysis
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.
|
|---|---|---|---|
|
Overall Study
Survey Non-response
|
71
|
94
|
92
|
Baseline Characteristics
Two survey respondents did not identify their 2016 plan.
Baseline characteristics by cohort
| Measure |
Control
n=313 Participants
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.
|
Expert Recommendation
n=316 Participants
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).
|
Individual Analysis
n=299 Participants
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
n=928 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.68 years
STANDARD_DEVIATION 4.64 • n=313 Participants
|
72.03 years
STANDARD_DEVIATION 4.55 • n=316 Participants
|
72.11 years
STANDARD_DEVIATION 4.50 • n=299 Participants
|
72.68 years
STANDARD_DEVIATION 4.64 • n=928 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=313 Participants
|
150 Participants
n=316 Participants
|
150 Participants
n=299 Participants
|
466 Participants
n=928 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=313 Participants
|
166 Participants
n=316 Participants
|
149 Participants
n=299 Participants
|
462 Participants
n=928 Participants
|
|
Race/Ethnicity, Customized
White
|
243 Participants
n=313 Participants
|
262 Participants
n=316 Participants
|
240 Participants
n=299 Participants
|
745 Participants
n=928 Participants
|
|
Race/Ethnicity, Customized
Asian
|
35 Participants
n=313 Participants
|
17 Participants
n=316 Participants
|
18 Participants
n=299 Participants
|
70 Participants
n=928 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=313 Participants
|
3 Participants
n=316 Participants
|
6 Participants
n=299 Participants
|
16 Participants
n=928 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=313 Participants
|
1 Participants
n=316 Participants
|
1 Participants
n=299 Participants
|
2 Participants
n=928 Participants
|
|
Race/Ethnicity, Customized
Other or missing
|
28 Participants
n=313 Participants
|
33 Participants
n=316 Participants
|
34 Participants
n=299 Participants
|
95 Participants
n=928 Participants
|
|
Estimated prescription drug spending
|
1496.80 US dollars
STANDARD_DEVIATION 1689.97 • n=312 Participants • Two survey respondents did not identify their 2016 plan.
|
1701.38 US dollars
STANDARD_DEVIATION 2068.86 • n=315 Participants • Two survey respondents did not identify their 2016 plan.
|
1580.56 US dollars
STANDARD_DEVIATION 1493.58 • n=299 Participants • Two survey respondents did not identify their 2016 plan.
|
1593.44 US dollars
STANDARD_DEVIATION 1771.73 • n=926 Participants • Two survey respondents did not identify their 2016 plan.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Control
n=301 Participants
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.
|
Expert Recommendation
n=305 Participants
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).
|
Individual Analysis
n=290 Participants
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).
|
|---|---|---|---|
|
Count of Participants Whose 2017 Plan Differed From Their 2016 Plan
|
85 Participants
|
110 Participants
|
86 Participants
|
PRIMARY outcome
Timeframe: within 50 days of the end of the open enrollment period.Population: Study participants who responded to decisional conflict questions on the final survey.
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.
Outcome measures
| Measure |
Control
n=302 Participants
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.
|
Expert Recommendation
n=296 Participants
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).
|
Individual Analysis
n=285 Participants
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).
|
|---|---|---|---|
|
Decisional Conflict
|
21.06 units on a scale
Standard Deviation 22.56
|
20.86 units on a scale
Standard Deviation 21.99
|
19.56 units on a scale
Standard Deviation 22.14
|
PRIMARY outcome
Timeframe: within 50 days of the end of the open enrollment periodPopulation: Study participants who responded to question about satisfaction with the choice process on the final survey
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.
Outcome measures
| Measure |
Control
n=313 Participants
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.
|
Expert Recommendation
n=316 Participants
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).
|
Individual Analysis
n=299 Participants
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).
|
|---|---|---|---|
|
Satisfaction With the Choice Process
|
122 Participants
|
148 Participants
|
134 Participants
|
PRIMARY outcome
Timeframe: within 50 days of the end of the open enrollment periodPopulation: Study participants who responded to questions about their 2017 plan choice in the final survey administered after open enrollment had ended.
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.
Outcome measures
| Measure |
Control
n=301 Participants
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.
|
Expert Recommendation
n=305 Participants
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).
|
Individual Analysis
n=290 Participants
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).
|
|---|---|---|---|
|
Change in Estimated Prescription Drug Spending
|
-178.90 US dollars
Standard Deviation 1029.93
|
-249.59 US dollars
Standard Deviation 899.81
|
-197.29 US dollars
Standard Deviation 599.38
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Expert Recommendation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Analysis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place