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Completed

NCT Number: NCT03631290

Deprescribing for Older Dialysis Patients

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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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

(providers):

None

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Number of Adverse Drug Withdrawal Events

    Time frame: 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.

  2. Change in Functional Assessment

    Time frame: 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.

  3. Change in Fall Risk Questionnaire

    Time frame: 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.

  4. Change in Patient Health Questionnaire-9 (PHQ9)

    Time frame: 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.

  5. Change in Cognitive Change Index

    Time frame: 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.

  6. Sustainability, as Measured by the Proportion of Patients Who Remained Off PIM at a Lower Dose

    Time frame: 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

  7. Practicality, as Measured by Average Time (in Days) Spent Awaiting Provider Response to Deprescribing Recommendation

    Time frame: 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.

  8. Practicality, as Measured by the Average Time (in Days) to Initial Patient Communication

    Time frame: Baseline

    The investigators will assess practicality in the QIP - Provider / Patient Communication format.

  9. Practicality, as Measured by the Average Number of Attempts to Reach the Patient

    Time frame: Baseline

    The investigators will assess practicality in the QIP - Provider / Patient Communication format.

  10. Practicality, as Measured by the Average Number of Conversations

    Time frame: Baseline

    The investigators will assess practicality in the QIP - Provider / Patient Communication format.

  11. Practicality, as Measured by the Average Length of Conversations With Patients About Deprescribing

    Time frame: Baseline

    The investigators will assess practicality in the QIP - Provider / Patient Communication format.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 15, 2018
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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