Prescription Drug Insurance Decision MakingCHOICENCT02895295
Evaluating a Patient-Centered Tool to Help Medicare Beneficiaries Choose Prescription Drug Plans
A study testing Expert Recommendation and Individual Analysis in people with Prescription Drug Insurance Decision Making, run by Stanford University.
Trial 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… Read more about this study
- Who is it for?
- Ages 66 to 85 years
- Conditions the study is for
- Prescription Drug Insurance Decision Making
- What is being tested?
- Expert Recommendation and Individual Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,185 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2016to 20 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Enrolled in a Medicare Advantage Plan and/or MediCal
About this study
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.
Read the 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.
- Being tested
- Expert Recommendation, Individual Analysis, Usual Care
- Keywords
- Medicare Part D, decision support, prescription drugs, expert recommendation, health insurance choice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert RecommendationBehavioural
Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.
Individual AnalysisBehavioural
Decision support tool that provides personalized information on the financial implications of enrolling in different plans.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Behavioral: Individual Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within 50 days of the end of the open enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start10 Sep 2016
- Primary completion20 Jan 2017
- Study completion20 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prescription Drug Insurance Decision MakingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Palo Alto Medical Foundation, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, M. Kate Bundorf, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895295
- Sponsor's protocol ID
- IRB-38241
- Other IDs
- CDR-1306-03598, 2016.107EXP
- Acronym
- CHOICE
- Status last verified
- Jul 2019
- First submitted
- 6 Sep 2016
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 21300518
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Patient-Centered Tool to Help Medicare Beneficiaries Choose Prescription Drug Plans
- ClinicalTrials.gov ID
- NCT02895295
- Acronym / sponsor ID
- CHOICE / IRB-38241
- Keywords
- Medicare Part D, decision support, prescription drugs, expert recommendation, health insurance choice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,185 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Palo Alto Medical Foundation, Patient-Centered Outcomes Research Institute
- Study start
- 10 Sep 2016 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Usual CareStudy 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. |
| Expert Recommendation | Experimental | Behavioral: Expert RecommendationParticipants 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). |
| Individual Analysis | Active comparator | Behavioral: Individual AnalysisParticipants 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. |
Who may qualify
- Ages
- 66 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Enrolled in a Medicare Advantage Plan and/or MediCal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expert RecommendationDecision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans. | Behavioural | Expert Recommendation |
| Individual AnalysisDecision support tool that provides personalized information on the financial implications of enrolling in different plans. | Behavioural | Individual Analysis |
| Usual CareStudy 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. | Behavioural | Control |
Primary outcome
Count of Participants Whose 2017 Plan Differed From Their 2016 Plan
Time frame: 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.
Decisional Conflict
Time frame: 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.
Satisfaction With the Choice Process
Time frame: 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.
Change in Estimated Prescription Drug Spending
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21300518Linder 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Expert Recommendation and Individual Analysis in people with Prescription Drug Insurance Decision Making, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants Whose 2017 Plan Differed From Their 2016 Plan (time frame: within 50 days of the end of the open enrollment period.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895295, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.