Deprescribing for Older Dialysis Patients

NCT03631290 | Completed Results

• 2 other identifiers: Pro001001841K76AG059930
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

kidney failure, chronic; renal dialysis; aged; inappropriate prescribing; preliminary data

Outcome Measures

Primary Outcomes (5)

• Number of Deprescribing Events

  Deprescribing events will be assessed for the Provider Only and Provider/Patient communication approaches. While this data is categorized into the two approaches, it is not intended for comparison.

  3 months

• Number of Potentially Eligible Subjects

  The study team identified patients aged 55 and older with active prescriptions for specific potentially inappropriate medications (PIMs) (gabapentinoids, clonidine, alpha blockers, muscle relaxants, and Z-drugs) from the medical record and met criteria for deprescribing.

  Baseline

• Proportion of Clinicians Who Found the Deprescribing Program Met Their Approval

  This is an assessment of provider acceptability, defined as those who answered "agree" or "completely agree" to the Likert item: The deprescribing program meets my approval.

  Baseline

• Proportion of Clinicians Who Found the Deprescribing Program Fit Their Routine

  This is an assessment of provider acceptability. The outcome was defined as those who answered "agree" or "completely agree" to the Likert item: The deprescribing program seems fitting with my clinical routine.

  Baseline

• Proportion of Clinicians Who Found the Deprescribing Program Seemed Doable

  This is an assessment of provider acceptability. The outcome was defined as those who answered "agree" or "completely agree" to the Likert item: The deprescribing program seems doable.

  Baseline

Secondary Outcomes (11)

• Number of Adverse Drug Withdrawal Events

  3 months

• Change in Functional Assessment

  Baseline, 3 months

• Change in Fall Risk Questionnaire

  Baseline, 3 months

• Change in Patient Health Questionnaire-9 (PHQ9)

  Baseline, 3 months

• Change in Cognitive Change Index

  Baseline, 3 months

Study Arms (2)

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.

Behavioral: Deprescribing Intervention

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

Interventions

Deprescribing Intervention 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.

Patients who were approached to undergo deprescribing

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient participants include community-dwelling hemodialysis patients. Providers will be Nephrologists and Advanced Practice Providers who are members of the Deprescribing QIP team at Duke-affiliated DaVita Dialysis clinics.

You may qualify if:

• 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)

You may not qualify if:

• advanced dementia
• hospice care
• non-English speaking
• 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
• None

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This ClinicalTrials.gov record and results are specific to Aim 2 of the protocol.

Results Point of Contact

• Title: Rasheeda Hall, M.D.
• Organization: Duke University Medical Center

rasheeda.hall@duke.edu

919-660-6861

Study Officials

• Rasheeda K Hall, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 15, 2018
• Study Start: March 9, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)