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Deprescribing for Older Dialysis Patients

Primary Purpose

Kidney Failure, Chronic

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Deprescribing Intervention

About this trial

This is an interventional health services research trial for Kidney Failure, Chronic focused on measuring kidney failure, chronic, renal dialysis, aged, inappropriate prescribing, preliminary data

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

an adult receiving dialysis for at least 6 months
at least one active prescription for a potentially inappropriate medication (e.g., opioid)

Exclusion Criteria:

advanced dementia
hospice care
non-English speaking

Sites / Locations

Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deprescribing Intervention

Arm Description

Outcomes

Primary Outcome Measures

proportion of deprescribing events

number of potentially eligible subjects

Secondary Outcome Measures

patient satisfaction as measured by interview

To understand how acceptable the intervention is to patients, the investigators will do interviews in a subset (12-15) of subjects

Full Information

NCT ID

NCT03631290

First Posted

August 9, 2018

Last Updated

August 1, 2023

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT03631290

Brief Title

Deprescribing for Older Dialysis Patients

Official Title

Deprescribing for Older Dialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 9, 2022 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Deprescribing Intervention

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Deprescribing Intervention

Intervention Description

Participants who are taking specific potentially inappropriate medications and their nephrologist will be engaged in the deprescribing process. The process involves deprescribing decision-making, implementation of deprescribing, and monitoring for adverse drug withdrawal events. The specific details of the deprescribing process are TBD.

Primary Outcome Measure Information:

Title

proportion of deprescribing events

Time Frame

6 months

Title

number of potentially eligible subjects

Time Frame

6 months

Secondary Outcome Measure Information:

Title

patient satisfaction as measured by interview

Description

To understand how acceptable the intervention is to patients, the investigators will do interviews in a subset (12-15) of subjects

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: an adult receiving dialysis for at least 6 months at least one active prescription for a potentially inappropriate medication (e.g., opioid) Exclusion Criteria: advanced dementia hospice care non-English speaking

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rasheeda K Hall

Phone

9196606861

rasheeda.stephens@duke.edu

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rasheeda Hall

Phone

919-660-6861

rasheeda.stephens@dm.duke.edu

12. IPD Sharing Statement

Plan to Share IPD

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Deprescribing for Older Dialysis Patients

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