Clinical trial NCT03631290: Deprescribing for Older Dialysis Patients
Official title: Deprescribing for Older Dialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Chronic
Keywords: kidney failure, chronic
renal dialysis
aged
inappropriate prescribing
preliminary data
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-08-15
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient participants include community-dwelling hemodialysis patients. Providers will be Nephrologists and Advanced Practice Providers who are members of the Deprescribing QIP team at Duke-affiliated DaVita Dialysis clinics.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Deprescribing Events
timeFrame: 3 months
measure: Number of Potentially Eligible Subjects
timeFrame: Baseline
measure: Proportion of Clinicians Who Found the Deprescribing Program Met Their Approval
timeFrame: Baseline
measure: Proportion of Clinicians Who Found the Deprescribing Program Fit Their Routine
timeFrame: Baseline
measure: Proportion of Clinicians Who Found the Deprescribing Program Seemed Doable
timeFrame: Baseline
Secondary outcomes:
measure: Number of Adverse Drug Withdrawal Events
timeFrame: 3 months
measure: Change in Functional Assessment
timeFrame: Baseline, 3 months
measure: Change in Fall Risk Questionnaire
timeFrame: Baseline, 3 months
measure: Change in Patient Health Questionnaire-9 (PHQ9)
timeFrame: Baseline, 3 months
measure: Change in Cognitive Change Index
timeFrame: Baseline, 3 months
measure: Sustainability, as Measured by the Proportion of Patients Who Remained Off PIM at a Lower Dose
timeFrame: 3 months
measure: Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation
timeFrame: Baseline
measure: Practicality, as Measured by the Average Time (in Days) to Initial Patient Communication
timeFrame: Baseline
measure: Practicality, as Measured by the Average Number of Attempts to Reach the Patient
timeFrame: Baseline
measure: Practicality, as Measured by the Average Number of Conversations
timeFrame: Baseline
measure: Practicality, as Measured by the Average Length of Conversations With Patients About Deprescribing
timeFrame: Baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Rasheeda K Hall, MD
role: PRINCIPAL_INVESTIGATOR
References: