Deprescribing for Older Dialysis Patients

Kidney Failure, Chronic Clinical Trial

Official title:

Deprescribing for Older Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631290
• Other study ID #: Pro00100184
• Secondary ID: 1K76AG059930
• Status: Completed
• Start date: March 9, 2022
• Est. completion date: December 13, 2023

Study information

• Verified date: May 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria (patients):

• 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)

Exclusion Criteria (patients):

• advanced dementia

• hospice care

• non-English speaking

Inclusion Criteria (providers):

• 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 (providers):

None

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of deprescribing events	Deprescribing events will be assessed for the Provider Only and Provider/Patient communication formats	3 months
Primary	Number of potentially eligible subjects		Baseline
Primary	Proportion of Clinicians who found the deprescribing program met their approval	This is an assessment of provider acceptability	Baseline
Primary	Proportion of Clinicians who found the deprescribing program fit their routine	This is an assessment of provider acceptability	Baseline
Primary	Proportion of Clinicians who found the deprescribing program seemed doable	This is an assessment of provider acceptability	Baseline
Secondary	Number of Adverse Drug Withdrawal Events		3 months
Secondary	Change in Functional Assessment		Baseline, 3 months
Secondary	Change in Fall Risk Questionnaire		Baseline, 3 months
Secondary	Change in Patient Health Questionnaire-9 (PHQ9)		Baseline, 3 months
Secondary	Change in Cognitive Change Index		Baseline, 3 months
Secondary	Sustainability, as measured by the proportion of patients who remained off PIM at a lower dose		3 months
Secondary	Practicality, as measured by average time (in days) spent awaiting provider response to deprescribing recommendation	The investigators will assess practicality across both Provider Only and Provider/Patient communication formats.	Baseline
Secondary	Practicality, as measured by the average time (in days) to initial patient communication	The investigators will assess practicality in the QIP - Provider / Patient Communication format.	Baseline
Secondary	Practicality, as measured by the average number of attempts to reach the patient	The investigators will assess practicality in the QIP - Provider / Patient Communication format.	Baseline
Secondary	Practicality, as measured by the average number of conversations	The investigators will assess practicality in the QIP - Provider / Patient Communication format.	Baseline
Secondary	Practicality, as measured by the average length of conversations with patients about deprescribing	The investigators will assess practicality in the QIP - Provider / Patient Communication format.	Baseline