Kidney Failure, ChronicNCT03631290
Deprescribing for Older Dialysis Patients
An observational study of Kidney Failure, Chronic, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Deprescribing Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 13 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient participants include community-dwelling hemodialysis patients. Providers will be Nephrologists and Advanced Practice Providers who are members of the Deprescribing QIP team at Duke-affiliated DaVita Dialysis clinics.
Who may be able to join
- 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)
- 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
Who cannot join
- advanced dementia
- hospice care
- non-English speaking
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Deprescribing Intervention
- Keywords
- kidney failure, chronic, renal dialysis, aged, inappropriate prescribing, preliminary data
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deprescribing InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Deprescribing Intervention | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Practicality, as Measured by the Average Number of Conversations
The investigators will assess practicality in the QIP - Provider / Patient Communication format.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start9 Mar 2022
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Rasheeda K Hall, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631290
- Sponsor's protocol ID
- Pro00100184
- Other IDs
- 1K76AG059930
- Status last verified
- Nov 2024
- First submitted
- 9 Aug 2018
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deprescribing for Older Dialysis Patients
- ClinicalTrials.gov ID
- NCT03631290
- Acronym / sponsor ID
- Pro00100184
- Conditions
- Kidney Failure, Chronic
- Keywords
- kidney failure, chronic, renal dialysis, aged, inappropriate prescribing, preliminary data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who were approached to undergo deprescribing | – | Behavioral: Deprescribing InterventionIf 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient participants include community-dwelling hemodialysis patients. Providers will be Nephrologists and Advanced Practice Providers who are members of the Deprescribing QIP team at Duke-affiliated DaVita Dialysis clinics.
Key inclusion criteria (4 listed)
- 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)
- 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
Key exclusion criteria (4 listed)
- advanced dementia
- hospice care
- non-English speaking
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deprescribing InterventionThe 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. | Behavioural | Patients who were approached to undergo deprescribing |
Primary outcome
Number of Deprescribing Events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
11 secondary outcomes
Number of Adverse Drug Withdrawal Events
Time frame: 3 months
Change in Functional Assessment
Time frame: Baseline, 3 months
Change in Fall Risk Questionnaire
Time frame: Baseline, 3 months
Change in Patient Health Questionnaire-9 (PHQ9)
Time frame: Baseline, 3 months
Change in Cognitive Change Index
Time frame: Baseline, 3 months
Sustainability, as Measured by the Proportion of Patients Who Remained Off PIM at a Lower Dose
Time frame: 3 months
Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation
Time frame: Baseline
Practicality, as Measured by the Average Time (in Days) to Initial Patient Communication
Time frame: Baseline
Practicality, as Measured by the Average Number of Attempts to Reach the Patient
Time frame: Baseline
Practicality, as Measured by the Average Number of Conversations
Time frame: Baseline
Practicality, as Measured by the Average Length of Conversations With Patients About Deprescribing
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasheeda K Hall, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Deprescribing Events (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.