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Psychological and Clinical Factors That Predict Intent to Deprescribe Medications Among Older Adults

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ClinicalTrials.gov Identifier: NCT04676282
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2020
Last Update Posted : January 8, 2021
Sponsor:
Collaborators:
Maastricht University
University of Iowa
Johns Hopkins University
Newcastle University
University of Sydney
Information provided by (Responsible Party):
Vordenberg, University of Michigan

Brief 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.

Condition or disease Intervention/treatment
Polypharmacy Aging Other: Hypothetical Scenario

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 the type of medication (e.g. addictive or non-addictive medication) 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.

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Study Type : Observational
Estimated Enrollment : 9600 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Psychological and Clinical Factors That Predict Intent to Deprescribe Medications Among Older Adults
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
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.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

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.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

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.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

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.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

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.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

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.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

Opioid - Self
Participants in this arm will be exposed to a scenario in which a patient takes an opioid pain medication. The participant will be asked to imagine that they are personally in this situation. The primary care provider raises the idea of stopping the medication.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

Opioid - Others
Participants in this arm will be exposed to a scenario in which a patient takes an opioid pain medication. The participant will be asked to consider how they think the hypothetical patient would respond. The primary care provider raises the idea of stopping the medication.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

Benzodiazepine - Self
Participants in this arm will be exposed to a scenario in which a patient takes a benzodiazepine for anxiety or sleep. The participant will be asked to imagine that they are personally in this situation. The primary care provider raises the idea of stopping the medication.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

Benzodiazepine - Others
Participants in this arm will be exposed to a scenario in which a patient takes a benzodiazepine for anxiety or sleep. The participant will be asked to consider how they think the hypothetical patient would respond. The primary care provider raises the idea of stopping the medication.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

Non-controlled medication - Self
Participants in this arm will be exposed to a scenario in which a patient takes a non-controlled medication for a chronic health condition. The participant will be asked to imagine that they are personally in this situation. The primary care provider raises the idea of stopping the medication.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.

Non-controlled medication - Others
Participants in this arm will be exposed to a scenario in which a patient takes a non-controlled medication for a chronic health condition. The participant will be asked to consider how they think the hypothetical patient would respond. The primary care provider raises the idea of stopping the medication.
Other: Hypothetical Scenario
Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults 65 years and older who reside in a participating country
Criteria

Inclusion Criteria:

  • 65 years and older
  • Resides in a participating country

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676282


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Maastricht University
University of Iowa
Johns Hopkins University
Newcastle University
University of Sydney
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Responsible Party: Vordenberg, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04676282    
Other Study ID Numbers: HUM00183129
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No