Trial Outcomes & Findings for Deprescribing for Older Dialysis Patients (NCT NCT03631290)
NCT ID: NCT03631290
Last Updated: 2025-02-03
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
48 participants
Primary outcome timeframe
3 months
Results posted on
2025-02-03
Participant Flow
Participants were not assigned to an arm upon entry. The study assessed two distinct approaches to shared decision-making: Provider Communication Only and Provider/Patient Communication. The purpose of the study was to assess feasibility of deprescribing overall and not to compare the two approaches. Therefore, participant data is only reported by decision-making group where practicality of Provider/Patient Communication was assessed. Providers were assessed as one group.
Participant milestones
| Measure |
Patients Who Were Approached to Undergo Deprescribing
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.
|
Providers
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
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|---|---|---|
|
Overall Study
STARTED
|
41
|
7
|
|
Overall Study
Participants Who Agreed to Deprescribe
|
17
|
0
|
|
Overall Study
COMPLETED
|
41
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was not collected from Providers
Baseline characteristics by cohort
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=41 Participants
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.
|
Providers
n=7 Participants
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
|
Total
n=48 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 8.1 • n=41 Participants • Age was not collected from Providers
|
—
|
67.2 years
STANDARD_DEVIATION 8.1 • n=41 Participants • Age was not collected from Providers
|
|
Sex: Female, Male
Female
|
19 Participants
n=41 Participants
|
2 Participants
n=7 Participants
|
21 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=41 Participants
|
5 Participants
n=7 Participants
|
27 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=41 Participants
|
0 Participants
n=7 Participants
|
40 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=41 Participants
|
0 Participants
n=7 Participants
|
32 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=41 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=48 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=41 Participants
|
7 participants
n=7 Participants
|
48 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 34 participants were Provider Only, and 7 were Provider/Patient Communication.
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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=41 Participants
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.
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|---|---|
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Number of Deprescribing Events
Provider Only Communication
|
15 deprescribing events
|
|
Number of Deprescribing Events
Provider/Patient Communication
|
2 deprescribing events
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PRIMARY outcome
Timeframe: BaselinePopulation: Total number of potentially eligible participants are reported. Not all potentially eligible participants were enrolled in the study.
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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=85 Participants
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.
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|---|---|
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Number of Potentially Eligible Subjects
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85 Participants
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PRIMARY outcome
Timeframe: BaselineThis 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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=7 Participants
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.
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|---|---|
|
Proportion of Clinicians Who Found the Deprescribing Program Met Their Approval
|
5 Participants
|
PRIMARY outcome
Timeframe: BaselineThis 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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=7 Participants
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.
|
|---|---|
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Proportion of Clinicians Who Found the Deprescribing Program Fit Their Routine
|
2 Participants
|
PRIMARY outcome
Timeframe: BaselineThis 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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=7 Participants
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.
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|---|---|
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Proportion of Clinicians Who Found the Deprescribing Program Seemed Doable
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only participants who agreed to deprescribe were assessed for 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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=17 Participants
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.
|
|---|---|
|
Number of Adverse Drug Withdrawal Events
|
7 events
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Of those approached, this subset agreed to complete assessments at the time of decision and 3 months after decision for deprescribing. This subset includes all individuals irrespective of their deprescribing decision (yes or no).
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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=11 Participants
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.
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|---|---|
|
Change in Functional Assessment
|
1.27 change in score on OARS assessment
Standard Error 0.47
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Of those approached, this subset agreed to complete assessments at the time of decision and 3 months after decision for deprescribing. This subset includes all individuals irrespective of their deprescribing decision (yes or no).
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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=11 Participants
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.
|
|---|---|
|
Change in Fall Risk Questionnaire
|
-0.3 change in score in CDC STEADI Fall Risk
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Of those approached, this subset agreed to complete assessments at the time of decision and 3 months after decision for deprescribing. This subset includes all individuals irrespective of their deprescribing decision (yes or no).
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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=11 Participants
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.
|
|---|---|
|
Change in Patient Health Questionnaire-9 (PHQ9)
|
-1.36 change in score on PHQ9
Standard Error 1.08
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Of those approached, this subset agreed to complete assessments at the time of decision and 3 months after decision for deprescribing. This subset includes all individuals irrespective of their deprescribing decision (yes or no).
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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=11 Participants
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.
|
|---|---|
|
Change in Cognitive Change Index
|
-2.8 change in cognitive change index score
Standard Error 10.8
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: only 6 participants were available for 3 month follow-up
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
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=6 Participants
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.
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|---|---|
|
Sustainability, as Measured by the Proportion of Patients Who Remained Off PIM at a Lower Dose
|
4 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 34 participants were Provider Only, and 7 were Provider/Patient Communication.
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.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=41 Participants
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.
|
|---|---|
|
Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation
Provider-only
|
10 days
Interval 5.0 to 32.0
|
|
Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation
Provider/Patient Communication
|
15 days
Interval 5.0 to 43.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis is limited to the 7 participants in the Provider/Patient Communication group.
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=7 Participants
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.
|
|---|---|
|
Practicality, as Measured by the Average Time (in Days) to Initial Patient Communication
|
21 days
Interval 7.0 to 30.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis is limited to the 7 participants in the Provider/Patient Communication group
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=7 Participants
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.
|
|---|---|
|
Practicality, as Measured by the Average Number of Attempts to Reach the Patient
|
4.3 number of attempts
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis is limited to the 7 participants in the Provider/Patient Communication group
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=7 Participants
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.
|
|---|---|
|
Practicality, as Measured by the Average Number of Conversations
|
1.4 number of conversations
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis is limited to the 7 participants in the Provider/Patient Communication group
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Outcome measures
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=7 Participants
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.
|
|---|---|
|
Practicality, as Measured by the Average Length of Conversations With Patients About Deprescribing
|
13.6 minutes
Standard Deviation 6.9
|
Adverse Events
Patients Who Were Approached to Undergo Deprescribing
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients Who Were Approached to Undergo Deprescribing
n=17 participants at risk
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.
|
Providers
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
|
|---|---|---|
|
Nervous system disorders
Intolerance of deprescribing
|
41.2%
7/17 • Within 1 month of starting to deprescribe the medication.
Adverse Drug Withdrawal Events (ADWEs) include a physiological withdrawal reaction or intolerance of deprescribing (worsened symptoms). ADWEs were collected for patients who were approached to undergo deprescribing, agreed to deprescribe, and then reported intolerance of cutting back or stopping the medication. No adverse events were collected from provider participants or patients who did not agree to undergo deprescribing.
|
—
0/0 • Within 1 month of starting to deprescribe the medication.
Adverse Drug Withdrawal Events (ADWEs) include a physiological withdrawal reaction or intolerance of deprescribing (worsened symptoms). ADWEs were collected for patients who were approached to undergo deprescribing, agreed to deprescribe, and then reported intolerance of cutting back or stopping the medication. No adverse events were collected from provider participants or patients who did not agree to undergo deprescribing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place