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

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.

Study Overview

• Status: Completed
• Conditions: Aging; Polypharmacy
• Intervention / Treatment: 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 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 Type: Observational
• Enrollment (Actual): 10184

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults 65 years and older who reside in a participating country

Description

Inclusion Criteria:

• 65 years and older
• Resides in a participating country

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

12

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Johns Hopkins University; University of Iowa; Newcastle University; University of Sydney; Maastricht University

Publications and helpful links

General Publications

• Vordenberg 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. 2022 Nov 14. doi: 10.1007/s11606-022-07850-5. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HUM00183129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No