An observational study in Kidney Failure, Chronic, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Duke University · Observational
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 48 is below the median of 149 across 394 observational studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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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.
Inclusion Criteria (patients):
Exclusion Criteria (patients):
Inclusion Criteria (providers):
Exclusion Criteria (providers):
None
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.
Behavioral: Deprescribing Intervention
Nephrologists and Advanced Practice Providers who see patients at a Duke affiliated DaVita hemodialysis (HD) clinic where Duke nephrologists serve as medical directors and rounding physicians
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.
Number of Deprescribing Events
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.
Time frame: 3 months
Number of Potentially Eligible Subjects
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.
Time frame: Baseline
Proportion of Clinicians Who Found the Deprescribing Program Met Their Approval
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.
Time frame: Baseline
Proportion of Clinicians Who Found the Deprescribing Program Fit Their Routine
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.
Time frame: Baseline
Proportion of Clinicians Who Found the Deprescribing Program Seemed Doable
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.
Time frame: Baseline
Number of Adverse Drug Withdrawal Events
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.
Time frame: 3 months
Change in Functional Assessment
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.
Time frame: Baseline, 3 months
Change in Fall Risk Questionnaire
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.
Time frame: Baseline, 3 months
Change in Patient Health Questionnaire-9 (PHQ9)
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.
Time frame: Baseline, 3 months
Change in Cognitive Change Index
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.
Time frame: Baseline, 3 months
Sustainability, as Measured by the Proportion of Patients Who Remained Off PIM at a Lower Dose
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
Time frame: 3 months
Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
Practicality, as Measured by the Average Number of Conversations
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Time frame: Baseline
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.
Time frame: Baseline
| Milestone | Patients Who Were Approached to Undergo Deprescribing | Providers |
|---|---|---|
| Started | 41 | 7 |
| Participants who agreed to deprescribe | 17 | 0 |
| Completed | 41 | 7 |
| Not completed | 0 | 0 |
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.
| deprescribing events | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Provider Only Communication | 15 |
| Provider/Patient Communication | 2 |
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.
| Participants | Number of Potentially Eligible Participants |
|---|---|
| Number of Potentially Eligible Subjects | 85 |
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.
| Participants | Providers |
|---|---|
| Proportion of Clinicians Who Found the Deprescribing Program Met Their Approval | 5 |
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.
| Participants | Providers |
|---|---|
| Proportion of Clinicians Who Found the Deprescribing Program Fit Their Routine | 2 |
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.
| Participants | Providers |
|---|---|
| Proportion of Clinicians Who Found the Deprescribing Program Seemed Doable | 5 |
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.
| events | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Number of Adverse Drug Withdrawal Events | 7 |
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 score on OARS assessment | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Change in Functional Assessment | 1.27 ± 0.47 |
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 score in CDC STEADI Fall Risk | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Change in Fall Risk Questionnaire | -0.3 ± 0.4 |
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 score on PHQ9 | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Change in Patient Health Questionnaire-9 (PHQ9) | -1.36 ± 1.08 |
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.
| change in cognitive change index score | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Change in Cognitive Change Index | -2.8 ± 10.8 |
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
| Participants | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Sustainability, as Measured by the Proportion of Patients Who Remained Off PIM at a Lower Dose | 4 |
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.
| days | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Provider-only | 10 (5 to 32) |
| Provider/Patient Communication | 15 (5 to 43) |
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
| days | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Practicality, as Measured by the Average Time (in Days) to Initial Patient Communication | 21 (7 to 30) |
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
| number of attempts | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Practicality, as Measured by the Average Number of Attempts to Reach the Patient | 4.3 ± 2.3 |
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
| number of conversations | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Practicality, as Measured by the Average Number of Conversations | 1.4 ± 0.8 |
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
| minutes | Patients Who Were Approached to Undergo Deprescribing |
|---|---|
| Practicality, as Measured by the Average Length of Conversations With Patients About Deprescribing | 13.6 ± 6.9 |
Collected over Within 1 month of starting to deprescribe the medication.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | 0/17 (0%) | 0/17 (0%) | 7/17 (41.2%) |
| Providers | — | — | — |
| Event | Patients Who Were Approached to Undergo Deprescribing | Providers |
|---|---|---|
| Intolerance of deprescribingNervous system disorders | 7/17 | — |
| Age, Continuous(years) | Patients Who Were Approached to Undergo Deprescribing | Providers | Total |
|---|---|---|---|
| Mean | 67.2 ± 8.1 | — | 67.2 ± 8.1 |
| Sex: Female, Male(Participants) | Patients Who Were Approached to Undergo Deprescribing | Providers | Total |
|---|---|---|---|
| Female | 19 | 2 | 21 |
| Male | 22 | 5 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Patients Who Were Approached to Undergo Deprescribing | Providers | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 40 | 0 | 40 |
| Unknown or Not Reported | 0 | 7 | 7 |
| Race (NIH/OMB)(Participants) | Patients Who Were Approached to Undergo Deprescribing | Providers | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 32 | 0 | 32 |
| White | 8 | 0 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 7 | 7 |
| Region of Enrollment(participants) | Patients Who Were Approached to Undergo Deprescribing | Providers | Total |
|---|---|---|---|
| United States | 41 | 7 | 48 |
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