Deprescribing for Older Dialysis Patients

NCT ID: NCT03631290

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2023-12-13

Brief Summary

Aim 1 of the study is to identify the elements of a deprescribing intervention that address contextual factors specific to dialysis.

Aim 2 of the study, described in this record, is to determine the feasibility of a deprescribing intervention tailored for older dialysis patients.

Older adults receiving dialysis are often prescribed multiple medications. Some of these medications are used to treat symptoms, but they also can increase the chance of significant health problems. The purpose of this study is to identify if it is feasible to reduce the use of medications that have been identified as causing an increased risk for health problems.

Conditions

Kidney Failure, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients who were approached to undergo deprescribing

If the patient's nephrologist agreed to attempt deprescribing the PIM, either the nephrologist (Provider Only Communication) or a study team member (pharmacist or nurse, Provider/Patient Communication) would engage the patient in discussion about deprescribing.

Deprescribing Intervention

Intervention Type: BEHAVIORAL

The deprescribing program was implemented as a clinical quality improvement project for patients receiving dialysis. Patients taking specific potentially inappropriate medications (PIMs) were identified in the medical record. The PIMs of interest included gabapentinoids, clonidine, alpha blockers, muscle relaxants, and Z-drugs. If their nephrologist agreed to attempt deprescribing the PIM, either the nephrologist (Provider Only Communication) or a study team member (pharmacist or nurse, Provider/Patient Communication) would engage the patient in discussion about deprescribing. This discussion included patient education materials about the risk of the medication. If the patient agreed, they were provided taper instructions (if indicated) and were followed up at 1 month and 3 months.

The patient was also invited to enroll in a study to be interviewed about the deprescribing decision and experience, and undergo brief assessment of geriatric problems at baseline and at 3 months.

Providers

Nephrologists and Advanced Practice Providers who see patients at a Duke affiliated DaVita hemodialysis (HD) clinic where Duke nephrologists serve as medical directors and rounding physicians

No interventions assigned to this group

Interventions

Deprescribing Intervention

The deprescribing program was implemented as a clinical quality improvement project for patients receiving dialysis. Patients taking specific potentially inappropriate medications (PIMs) were identified in the medical record. The PIMs of interest included gabapentinoids, clonidine, alpha blockers, muscle relaxants, and Z-drugs. If their nephrologist agreed to attempt deprescribing the PIM, either the nephrologist (Provider Only Communication) or a study team member (pharmacist or nurse, Provider/Patient Communication) would engage the patient in discussion about deprescribing. This discussion included patient education materials about the risk of the medication. If the patient agreed, they were provided taper instructions (if indicated) and were followed up at 1 month and 3 months.

The patient was also invited to enroll in a study to be interviewed about the deprescribing decision and experience, and undergo brief assessment of geriatric problems at baseline and at 3 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• an adult receiving dialysis for at least 6 months
• at least one active prescription for a potentially inappropriate medication (gabapentinoids, clonidine, alpha blockers, muscle relaxants, and Z-drugs)

• must be employed by Duke
• must see patients at a Duke affiliated DaVita hemodialysis (HD) clinic where Duke nephrologists serve as medical directors and rounding physicians

Exclusion Criteria

• advanced dementia
• hospice care
• non-English speaking

None

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rasheeda K Hall, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K76AG059930

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00100184

Identifier Type: -

Identifier Source: org_study_id