Deprescribing for Older Dialysis Patients

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Behavioral: Deprescribing Intervention

• Registration Number: NCT03631290
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2022-03-09
• Primary Completion: 2023-12-13
• Study Completion: 2023-12-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who were approached to undergo deprescribing	Deprescribing Intervention	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.

Primary Outcome Measures

Name	Time	Method
Number of potentially eligible subjects	Baseline
Proportion of Clinicians who found the deprescribing program seemed doable	Baseline	This is an assessment of provider acceptability
Proportion of deprescribing events	3 months	Deprescribing events will be assessed for the Provider Only and Provider/Patient communication formats
Proportion of Clinicians who found the deprescribing program fit their routine	Baseline	This is an assessment of provider acceptability
Proportion of Clinicians who found the deprescribing program met their approval	Baseline	This is an assessment of provider acceptability

Secondary Outcome Measures

Name	Time	Method
Change in Fall Risk Questionnaire	Baseline, 3 months
Change in Patient Health Questionnaire-9 (PHQ9)	Baseline, 3 months
Practicality, as measured by the average number of attempts to reach the patient	Baseline	The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Change in Cognitive Change Index	Baseline, 3 months
Practicality, as measured by average time (in days) spent awaiting provider response to deprescribing recommendation	Baseline	The investigators will assess practicality across both Provider Only and Provider/Patient communication formats.
Practicality, as measured by the average time (in days) to initial patient communication	Baseline	The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Practicality, as measured by the average length of conversations with patients about deprescribing	Baseline	The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Number of Adverse Drug Withdrawal Events	3 months
Change in Functional Assessment	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 the average number of conversations	Baseline	The investigators will assess practicality in the QIP - Provider / Patient Communication format.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States