Kidney Failure, Chronic
Conditions
Keywords
kidney failure, chronic, renal dialysis, aged, inappropriate prescribing, preliminary data
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.
Interventions
BEHAVIORALDeprescribing 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.
Sponsors
National Institute on Aging (NIA)
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 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 | 7 |
| Total | 48 |
Baseline characteristics
| Characteristic | Patients Who Were Approached to Undergo Deprescribing | Total | Providers |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 8.1 | 67.2 years STANDARD_DEVIATION 8.1 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 40 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants | 32 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants | 0 Participants |
| Region of Enrollment United States | 41 participants | 48 participants | 7 participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 2 Participants |
| Sex: Female, Male Male | 22 Participants | 27 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 0 |
| other Total, other adverse events | 7 / 17 | 0 / 0 |
| serious Total, serious adverse events | 0 / 17 | 0 / 0 |
Outcome results
Primary
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
Population: 34 participants were Provider Only, and 7 were Provider/Patient Communication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Number of Deprescribing Events | Provider Only Communication | 15 deprescribing events |
| Patients Who Were Approached to Undergo Deprescribing | Number of Deprescribing Events | Provider/Patient Communication | 2 deprescribing events |
Primary
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
Population: Total number of potentially eligible participants are reported. Not all potentially eligible participants were enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Number of Potentially Eligible Subjects | 85 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Proportion of Clinicians Who Found the Deprescribing Program Fit Their Routine | 2 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Proportion of Clinicians Who Found the Deprescribing Program Met Their Approval | 5 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Proportion of Clinicians Who Found the Deprescribing Program Seemed Doable | 5 Participants |
Secondary
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
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Change in Cognitive Change Index | -2.8 change in cognitive change index score | Standard Error 10.8 |
Secondary
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
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Change in Fall Risk Questionnaire | -0.3 change in score in CDC STEADI Fall Risk | Standard Error 0.4 |
Secondary
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
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Change in Functional Assessment | 1.27 change in score on OARS assessment | Standard Error 0.47 |
Secondary
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
Population: 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).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Change in Patient Health Questionnaire-9 (PHQ9) | -1.36 change in score on PHQ9 | Standard Error 1.08 |
Secondary
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
Population: Only participants who agreed to deprescribe were assessed for adverse drug withdrawal events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Number of Adverse Drug Withdrawal Events | 7 events |
Secondary
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
Population: 34 participants were Provider Only, and 7 were Provider/Patient Communication.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation | Provider-only | 10 days |
| Patients Who Were Approached to Undergo Deprescribing | Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation | Provider/Patient Communication | 15 days |
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.
Time frame: Baseline
Population: Analysis is limited to the 7 participants in the Provider/Patient Communication group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Practicality, as Measured by the Average Length of Conversations With Patients About Deprescribing | 13.6 minutes | Standard Deviation 6.9 |
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.
Time frame: Baseline
Population: Analysis is limited to the 7 participants in the Provider/Patient Communication group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Practicality, as Measured by the Average Number of Attempts to Reach the Patient | 4.3 number of attempts | Standard Deviation 2.3 |
Secondary
Practicality, as Measured by the Average Number of Conversations
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Time frame: Baseline
Population: Analysis is limited to the 7 participants in the Provider/Patient Communication group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Practicality, as Measured by the Average Number of Conversations | 1.4 number of conversations | Standard Deviation 0.8 |
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.
Time frame: Baseline
Population: Analysis is limited to the 7 participants in the Provider/Patient Communication group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Who Were Approached to Undergo Deprescribing | Practicality, as Measured by the Average Time (in Days) to Initial Patient Communication | 21 days |
Secondary
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
Population: only 6 participants were available for 3 month follow-up
| Arm | Measure | Value (COUNT_OF_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 Participants |