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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676282
• Other study ID #: HUM00183129
• Status: Completed
• Start date: December 17, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10184
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years and older

• Resides in a participating country

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Aging
• Polypharmacy

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (6)

Lead Sponsor	Collaborator
University of Michigan	Johns Hopkins University, Maastricht University, Newcastle University, University of Iowa, University of Sydney

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year