PolypharmacyNCT04676282
Psychological and Clinical Factors That Predict Intent to Deprescribe Medications Among Older Adults
An observational study of Polypharmacy and Aging, run by University of Michigan at 1 site in United States.
Trial summary
The investigators are conducting two experimental surveys to explore clinical and psychological factors that influence older adults' willingness to stop medications in the face of polypharmacy. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy, Aging
- What is being tested?
- Hypothetical Scenario
- How many people
- 10,184 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Adults 65 years and older who reside in a participating country
Who may be able to join
- 65 years and older
- Resides in a participating country
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The investigators are conducting two experimental surveys to explore clinical and psychological factors that influence older adults' willingness to stop medications in the face of polypharmacy.
Read the detailed description
Around one-half of older adults take one or more medications that are inappropriate or medically unnecessary. These medications can cause side effects that are unacceptable to patients. Several studies provide guidance to clinicians about the process of stopping specific types of medications (e.g., steps that clinicians can take to reduce and stop a medication for anxiety or difficulty sleeping). However, these approaches are not always successful. A critical gap with these approaches is they tend to focus on the medication, rather than the patient, and their individual needs.
Our research team seeks to learn more about factors that are important to patients when they consider reducing or stopping a medication. The investigators will do this by conducting two surveys each with 4,800 older adults across four countries (United States, United Kingdom, Netherlands, and Australia). Each participant will be asked to give their opinions on a hypothetical patient scenario that has been developed by our diverse team in partnership with our stakeholder organizations. In the first survey, the investigators will examine how the reason for using the medication (e.g. preventing a disease or treating symptoms of a disease) as well as the reason for a recommendation to stop the medication (e.g. lack of benefit vs. potential for harm) influence older adults' willingness to stop medications. In the second survey, the investigators will examine how different social and clinical factors and whether the participant is making a recommendation about oneself (as if they were the patient in the case) or on behalf of the patient in the case (e.g., if it was their friend) influence their willingness to stop medications. The investigators will work with Qualtrics, an international company that distributes surveys, to collect this data that does not include any identifying information.
The investigators anticipate that once the survey is designed and show that it is successful for studying patient perspectives about stopping medicines, it can then apply the same study approach to test the effect of other relevant factor that may influence the decision to stop or reduce a medication. The investigators anticipate that our research will significantly contribute to our understanding of how older adults make decisions about stopping medications. This information will be helpful to researchers and clinicians to ensure future services can be developed to best support patients to make decisions about stopping or reducing inappropriate or unnecessary medication.
- Conditions
- Polypharmacy, Aging
- Being tested
- Hypothetical Scenario
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothetical ScenarioOther
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
| Study group | Role | What they receive |
|---|---|---|
| Survey 1 Statin - May cause harm | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm. Receives: Other: Hypothetical Scenario | |
| Survey 1 Stain - May lack benefit | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may lack benefit. Receives: Other: Hypothetical Scenario | |
| Survey 1 Statin - May cause harm and lack benefit | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm and lack benefit. Receives: Other: Hypothetical Scenario | |
| Survey 1 PPI - May cause harm | Participants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may be causing harm. Receives: Other: Hypothetical Scenario | |
| Survey 1 PPI - May lack benefit | Participants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may lack benefit. Receives: Other: Hypothetical Scenario | |
| Survey 1 PPI - May cause harm and lack benefit | Participants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may be causing harm and lack benefit. Receives: Other: Hypothetical Scenario | |
| Survey 2 Statin - May cause harm and lack benefit | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm and lack benefit. Receives: Other: Hypothetical Scenario | |
| Survey 2 Statin - Cardiologist | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin previously started by a cardiologist. Receives: Other: Hypothetical Scenario | |
| Survey 2 Statin - Daughter Preference | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient's adult daughter prefers for her to continue the medication. Receives: Other: Hypothetical Scenario | |
| Survey 2 Statin - Husband Stroke | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient's husband previously had a stroke after he stopped his statin. Receives: Other: Hypothetical Scenario | |
| Survey 2 Statin - Flier | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient saw an educational flier about strokes in the waiting room. Receives: Other: Hypothetical Scenario | |
| Survey 2 Statin - Difficulty Maintaining Lifestyle Changes | Participants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient recognizes that they have had difficulty exercising and eating healthier foods. Receives: Other: Hypothetical Scenario |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to question statement "I think that Mrs. EF should follow her PCPs recommendation and stop taking simvastatin."
Level of agreement with the primary care provider's recommendation to stop the medication presented in the hypothetical scenario (1=strongly disagree, 6=strongly agree)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start17 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, University of Iowa, Johns Hopkins University, Newcastle University, University of Sydney
- Responsible party
- Principal investigator, Vordenberg, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676282
- Sponsor's protocol ID
- HUM00183129
- Status last verified
- Jan 2022
- First submitted
- 9 Dec 2020
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weir KR, Marshall VD, Vordenberg SE. Latent Class Analysis Identifies Four Distinct Patient Deprescribing Typologies Among Older Adults in Four Countries. Innov Aging. 2025 Jan 17;9(2):igaf002. doi: 10.1093/geroni/igaf002. eCollection 2025.
PubMed 40008009Vordenberg SE, Weir KR, Jansen J, Todd A, Schoenborn N, Scherer AM. Harm and Medication-Type Impact Agreement with Hypothetical Deprescribing Recommendations: a Vignette-Based Experiment with Older Adults Across Four Countries. J Gen Intern Med. 2023 May;38(6):1439-1448. doi: 10.1007/s11606-022-07850-5. Epub 2022 Nov 14.
PubMed 36376636
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Clinical Factors That Predict Intent to Deprescribe Medications Among Older Adults
- ClinicalTrials.gov ID
- NCT04676282
- Acronym / sponsor ID
- HUM00183129
- Conditions
- Polypharmacy, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,184 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Maastricht University, University of Iowa, Johns Hopkins University, Newcastle University, University of Sydney
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are conducting two experimental surveys to explore clinical and psychological factors that influence older adults' willingness to stop medications in the face of polypharmacy.
Detailed description
Around one-half of older adults take one or more medications that are inappropriate or medically unnecessary. These medications can cause side effects that are unacceptable to patients. Several studies provide guidance to clinicians about the process of stopping specific types of medications (e.g., steps that clinicians can take to reduce and stop a medication for anxiety or difficulty sleeping). However, these approaches are not always successful. A critical gap with these approaches is they tend to focus on the medication, rather than the patient, and their individual needs.
Our research team seeks to learn more about factors that are important to patients when they consider reducing or stopping a medication. The investigators will do this by conducting two surveys each with 4,800 older adults across four countries (United States, United Kingdom, Netherlands, and Australia). Each participant will be asked to give their opinions on a hypothetical patient scenario that has been developed by our diverse team in partnership with our stakeholder organizations. In the first survey, the investigators will examine how the reason for using the medication (e.g. preventing a disease or treating symptoms of a disease) as well as the reason for a recommendation to stop the medication (e.g. lack of benefit vs. potential for harm) influence older adults' willingness to stop medications. In the second survey, the investigators will examine how different social and clinical factors and whether the participant is making a recommendation about oneself (as if they were the patient in the case) or on behalf of the patient in the case (e.g., if it was their friend) influence their willingness to stop medications. The investigators will work with Qualtrics, an international company that distributes surveys, to collect this data that does not include any identifying information.
The investigators anticipate that once the survey is designed and show that it is successful for studying patient perspectives about stopping medicines, it can then apply the same study approach to test the effect of other relevant factor that may influence the decision to stop or reduce a medication. The investigators anticipate that our research will significantly contribute to our understanding of how older adults make decisions about stopping medications. This information will be helpful to researchers and clinicians to ensure future services can be developed to best support patients to make decisions about stopping or reducing inappropriate or unnecessary medication.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Survey 1 Statin - May cause harm | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm. |
| Survey 1 Stain - May lack benefit | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may lack benefit. |
| Survey 1 Statin - May cause harm and lack benefit | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm and lack benefit. |
| Survey 1 PPI - May cause harm | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may be causing harm. |
| Survey 1 PPI - May lack benefit | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may lack benefit. |
| Survey 1 PPI - May cause harm and lack benefit | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a proton pump inhibitor (heartburn) medication. The primary care provider raises the idea of stopping the PPI as it may be causing harm and lack benefit. |
| Survey 2 Statin - May cause harm and lack benefit | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin as it may be causing harm and lack benefit. |
| Survey 2 Statin - Cardiologist | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin previously started by a cardiologist. |
| Survey 2 Statin - Daughter Preference | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient's adult daughter prefers for her to continue the medication. |
| Survey 2 Statin - Husband Stroke | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient's husband previously had a stroke after he stopped his statin. |
| Survey 2 Statin - Flier | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient saw an educational flier about strokes in the waiting room. |
| Survey 2 Statin - Difficulty Maintaining Lifestyle Changes | – | Other: Hypothetical ScenarioParticipants in this arm will be exposed to a scenario in which a patient takes a statin (cholesterol) medication. The primary care provider raises the idea of stopping the statin but the patient recognizes that they have had difficulty exercising and eating healthier foods. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Adults 65 years and older who reside in a participating country
Key inclusion criteria (2 listed)
- 65 years and older
- Resides in a participating country
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Hypothetical ScenarioParticipants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario. | Other | Survey 1 PPI - May cause harm, Survey 1 PPI - May cause harm and lack benefit, Survey 1 PPI - May lack benefit, Survey 1 Stain - May lack benefit, Survey 1 Statin - May cause harm, Survey 1 Statin - May cause harm and lack benefit, Survey 2 Statin - Cardiologist, Survey 2 Statin - Daughter Preference, Survey 2 Statin - Difficulty Maintaining Lifestyle Changes, Survey 2 Statin - Flier, Survey 2 Statin - Husband Stroke, Survey 2 Statin - May cause harm and lack benefit |
Primary outcome
Response to question statement "I think that Mrs. EF should follow her PCPs recommendation and stop taking simvastatin."
Time frame: 1 year
Level of agreement with the primary care provider's recommendation to stop the medication presented in the hypothetical scenario (1=strongly disagree, 6=strongly agree)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 40008009Weir KR, Marshall VD, Vordenberg SE. Latent Class Analysis Identifies Four Distinct Patient Deprescribing Typologies Among Older Adults in Four Countries. Innov Aging. 2025 Jan 17;9(2):igaf002. doi: 10.1093/geroni/igaf002. eCollection 2025.
- Derived from this study: PubMed 36376636Vordenberg SE, Weir KR, Jansen J, Todd A, Schoenborn N, Scherer AM. Harm and Medication-Type Impact Agreement with Hypothetical Deprescribing Recommendations: a Vignette-Based Experiment with Older Adults Across Four Countries. J Gen Intern Med. 2023 May;38(6):1439-1448. doi: 10.1007/s11606-022-07850-5. Epub 2022 Nov 14.
- Individual participant dataSharing planned: No
Related trials for Polypharmacy
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Active, not recruiting
Optimizing Prescribing Decisions for Hospitalized Older Adults With Chronic Conditions
Prescribing Decisions, Diabetes
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Active, not recruiting
Improving Medication Management in World Trade Center Responders
Polypharmacy
Recruiting
PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)
Pharmacogenomic Drug Interaction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polypharmacy and Aging, run by University of Michigan at 1 site in United States.
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 2 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response to question statement "I think that Mrs. EF should follow her PCPs recommendation and stop taking simvastatin." (time frame: 1 year). 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 NCT04676282, which also lists 2 linked publications.
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 13 Jan 2022.