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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT04676282
Collaborator
Maastricht University (Other), University of Iowa (Other), Johns Hopkins University (Other), Newcastle University (Other), University of Sydney (Other)
10,184
1
12.5
817.9

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
10184 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 :
Dec 17, 2020
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Response to question statement "I think that Mrs. EF should follow her PCPs recommendation and stop taking simvastatin." [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 65 years and older

  • Resides in a participating country

Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vordenberg, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT04676282
Other Study ID Numbers:
  • HUM00183129
First Posted:
Dec 21, 2020
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 13, 2022