An interventional study of Expert Recommendation and Individual Analysis in Prescription Drug Insurance Decision Making, sponsored by Stanford University. Completed. Open to participants aged 66 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by Stanford University · Not applicable, Interventional, and Health services research
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.
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.
Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
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
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
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 and expert recommendations of particular plans.
Decision support tool that provides personalized information on the financial implications of enrolling in different plans.
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.
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.
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.
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
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
| Milestone | Control | Expert Recommendation | Individual Analysis |
|---|---|---|---|
| Started | 384 | 410 | 391 |
| Completed | 313 | 316 | 299 |
| Not completed | 71 | 94 | 92 |
| Withdrew: Survey non-response | 71 | 94 | 92 |
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.
| Participants | Control | Expert Recommendation | Individual Analysis |
|---|---|---|---|
| Count of Participants Whose 2017 Plan Differed From Their 2016 Plan | 85 | 110 | 86 |
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.
| units on a scale | Control | Expert Recommendation | Individual Analysis |
|---|---|---|---|
| Decisional Conflict | 21.06 ± 22.56 | 20.86 ± 21.99 | 19.56 ± 22.14 |
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.
| Participants | Control | Expert Recommendation | Individual Analysis |
|---|---|---|---|
| Satisfaction With the Choice Process | 122 | 148 | 134 |
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.
| US dollars | Control | Expert Recommendation | Individual Analysis |
|---|---|---|---|
| Change in Estimated Prescription Drug Spending | -178.90 ± 1029.93 | -249.59 ± 899.81 | -197.29 ± 599.38 |
Collected over Data were not collected for adverse events or all-cause mortality in this study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | — | — |
| Expert Recommendation | — | — | — |
| Individual Analysis | — | — | — |
The baseline population represent the number of study participants who completed the final survey administered after the open enrollment period ended.
| Age, Continuous(years) | Control | Expert Recommendation | Individual Analysis | Total |
|---|---|---|---|---|
| Mean | 72.68 ± 4.64 | 72.03 ± 4.55 | 72.11 ± 4.50 | 72.68 ± 4.64 |
| Sex: Female, Male(Participants) | Control | Expert Recommendation | Individual Analysis | Total |
|---|---|---|---|---|
| Female | 166 | 150 | 150 | 466 |
| Male | 147 | 166 | 149 | 462 |
| Race/Ethnicity, Customized(Participants) | Control | Expert Recommendation | Individual Analysis | Total |
|---|---|---|---|---|
| White | 243 | 262 | 240 | 745 |
| Asian | 35 | 17 | 18 | 70 |
| Hispanic | 7 | 3 | 6 | 16 |
| Black | 0 | 1 | 1 | 2 |
| Other or missing | 28 | 33 | 34 | 95 |
| Estimated prescription drug spending(US dollars) | Control | Expert Recommendation | Individual Analysis | Total |
|---|---|---|---|---|
| Mean | 1496.80 ± 1689.97 | 1701.38 ± 2068.86 | 1580.56 ± 1493.58 | 1593.44 ± 1771.73 |
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