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Clinical Trials/NCT03631290
NCT03631290
Completed
Not Applicable

Deprescribing for Older Dialysis Patients

Duke University1 site in 1 country48 target enrollmentMarch 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Failure, Chronic
Sponsor
Duke University
Enrollment
48
Locations
1
Primary Endpoint
Number of Deprescribing Events
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 9, 2022
End Date
December 13, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Deprescribing Events

Time Frame: 3 months

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.

Number of Potentially Eligible Subjects

Time Frame: Baseline

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.

Proportion of Clinicians Who Found the Deprescribing Program Met Their Approval

Time Frame: Baseline

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.

Proportion of Clinicians Who Found the Deprescribing Program Fit Their Routine

Time Frame: Baseline

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.

Proportion of Clinicians Who Found the Deprescribing Program Seemed Doable

Time Frame: Baseline

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.

Secondary Outcomes

  • 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)
  • Sustainability, as Measured by the Proportion of Patients Who Remained Off PIM at a Lower Dose(3 months)
  • Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation(Baseline)
  • Practicality, as Measured by the Average Time (in Days) to Initial Patient Communication(Baseline)
  • Practicality, as Measured by the Average Number of Attempts to Reach the Patient(Baseline)
  • Practicality, as Measured by the Average Number of Conversations(Baseline)
  • Practicality, as Measured by the Average Length of Conversations With Patients About Deprescribing(Baseline)

Study Sites (1)

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