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| ID | Type | Description | Link |
|---|---|---|---|
| 1K76AG059930 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who were approached to undergo deprescribing | 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. |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deprescribing Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Change in Functional Assessment |
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Inclusion Criteria (patients):
Exclusion Criteria (patients):
Inclusion Criteria (providers):
Exclusion Criteria (providers):
None
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rasheeda K Hall, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not collected from Providers |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 34 participants were Provider Only, and 7 were Provider/Patient Communication. | Posted | Number | deprescribing events | 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intolerance of deprescribing | Nervous system disorders | Systematic Assessment | Intolerance of deprescribing includes worsening or return of symptoms. Because the medications deprescribed addressed pain, we associate these ADWE with the Nervous Systems organ system. |
This ClinicalTrials.gov record and results are specific to Aim 2 of the protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rasheeda Hall, M.D. | Duke University Medical Center | 919-660-6861 | rasheeda.hall@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2024 | Nov 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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.
| 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. | 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. | 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. | 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 | 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. | 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. | 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. | Baseline |
| Practicality, as Measured by the Average Number of Conversations | The investigators will assess practicality in the QIP - Provider / Patient Communication format. | 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. | Baseline |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| 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. | Total number of potentially eligible participants are reported. Not all potentially eligible participants were enrolled in the study. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Only participants who agreed to deprescribe were assessed for adverse drug withdrawal events. | Posted | Number | events | 3 months |
|
|
|
| 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. | 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). | Posted | Mean | Standard Error | change in score on OARS assessment | Baseline, 3 months |
|
|
|
| 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. | 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). | Posted | Mean | Standard Error | change in score in CDC STEADI Fall Risk | Baseline, 3 months |
|
|
|
| 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. | 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). | Posted | Median | Standard Error | change in score on PHQ9 | Baseline, 3 months |
|
|
|
| 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. | 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). | Posted | Mean | Standard Error | change in cognitive change index score | Baseline, 3 months |
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| 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 | only 6 participants were available for 3 month follow-up | Posted | Count of Participants | Participants | 3 months |
|
|
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| 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. | 34 participants were Provider Only, and 7 were Provider/Patient Communication. | Posted | Median | Inter-Quartile Range | days | Baseline |
|
|
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| 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. | Analysis is limited to the 7 participants in the Provider/Patient Communication group. | Posted | Median | Inter-Quartile Range | days | Baseline |
|
|
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| 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. | Analysis is limited to the 7 participants in the Provider/Patient Communication group | Posted | Mean | Standard Deviation | number of attempts | Baseline |
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| Secondary | Practicality, as Measured by the Average Number of Conversations | The investigators will assess practicality in the QIP - Provider / Patient Communication format. | Analysis is limited to the 7 participants in the Provider/Patient Communication group | Posted | Mean | Standard Deviation | number of conversations | Baseline |
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| 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. | Analysis is limited to the 7 participants in the Provider/Patient Communication group | Posted | Mean | Standard Deviation | minutes | Baseline |
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|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 7 |
| 17 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|