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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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 Deprescribing Events	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	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	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	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	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 Outcome Measures

Name	Time	Method
Number of Adverse Drug Withdrawal Events	3 months	Symptoms develop related to cutting back or stopping a medication. This was identified by chart review and/or if reported by patient to study team.
Change in Functional Assessment	Baseline, 3 months	Enrolled participants completed the Older Americans Resources and Services (OARS) functional assessment which assesses instrumental and basic activities of daily living (ADLs). The instrument scores range from 0-28, with higher scores indicating better ability to do ADLs.
Change in Fall Risk Questionnaire	Baseline, 3 months	Enrolled participants completed the CDC STEADI Fall Risk instrument. The instrument scores range from 0-14, with higher scores indicating a greater risk of falls.
Change in Patient Health Questionnaire-9 (PHQ9)	Baseline, 3 months	Enrolled participants completed the PHQ9 instrument which assesses for depression. The instrument scores range from 0-27, with higher scores indicating a greater depression severity.
Change in Cognitive Change Index	Baseline, 3 months	Enrolled participants completed the Cognitive Change Index instrument which assesses for cognition. The instrument scores range from 0-100, with higher scores indicating a greater likelihood of cognitive impairment.
Sustainability, as Measured by the Proportion of Patients Who Remained Off PIM at a Lower Dose	3 months	Among those who deprescribed, the study team followed up by phone to inquire if they were still off the PIM and/or taking a lower dose than before
Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation	Baseline	The investigators will compare practicality of Provider-only Communication and Provider/Patient Communication because the Provider/Patient Communication involved additional staff outside of the dialysis clinic and such staff would not be guaranteed in real-world application of this intervention.
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 Number of Attempts to Reach the Patient	Baseline	The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Practicality, as Measured by the Average Number of Conversations	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.