Targeted Deprescribing in Patients on Hemodialysis

December 9, 2024 updated by: Marisa Battistella, University Health Network, Toronto

Implementation of Deprescribing and Patient Education Tools in Hemodialysis Units to Decrease Polypharmacy

Hemodialysis (HD) patients take more pills per day on average than any other chronically ill patient population. On average, an HD patient takes 19 medications per day, of which 70% may not be appropriate. The reason the medications may not be appropriate is that HD patients are rarely included in clinical trials for new medications and therefore the efficacy and safety data that exists for the general population may not actually apply to them. Tools to guide the re-assessment and discontinuation (deprescribing) of these specific medications that lack evidence for efficacy and safety in HD patients are needed. These tools will help reduce the amount of medications being taken and the potential negative consequences of taking so many medications (e.g. adverse drug reactions, drug interactions, non-adherence, increased risk of cognitive impairment, impaired balance and falls, and increased risk of morbidity, hospitalization, and mortality).

Nine medications that are often inappropriately prescribed to HD patients have been identified by the investigators. These medications are: Alpha-1 Blockers, Anticonvulsants, Benzodiazepines & Z-Drugs, Loop Diuretics, Prokinetic Agents, Proton Pump Inhibitors, Quinine, Urate Lowering Agents, and Statins. The investigators developed and validated tools to help medical teams in outpatient HD units with identifying and stopping these medications in their patients. The next step will be to perform a study where test these tools are tested in practice at multiple HD centers across Canada. This initiative should decrease the average number of medications per patient and inappropriate medication use in the HD units where these tools are used. The overall objective of this study is to improve current clinical practice by optimizing medication use and prescribing patterns in the HD units across Canada.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Hemodialysis (HD) patients are rarely included in clinical trials, thus medication efficacy and safety data specific to this population is lacking. Toxicity from medications inadequately removed by dialysis is also a risk for them. HD patients take an average of 19 pills daily, with 70% potentially inappropriate.

This polypharmacy increases their risk of adverse events, drug-drug interactions, non-adherence, cognitive impairment, impaired balance and falls, morbidity, hospitalization and mortality. Using provincial databases, the investigators identified 9 medication classes with uncertain indications and/or safety in HD patients: Alpha-1 Blockers, Anticonvulsants, Benzodiazepines & Z-medications, Loop Diuretics, Prokinetic Agents, Proton Pump Inhibitors, Quinine, Urate Lowering Agents and Statins. The investigators developed and validated tools for deprescribing, safety monitoring and patient education for each of these medications. The next step will be to perform an implementation study evaluating these deprescribing tools at multiple HD units across Canada.

The investigators hypothesize that implementation of these deprescribing tools will decrease polypharmacy and improve safety and patient satisfaction in these HD units. Specific Aims are to determine:

  1. Effectiveness of the deprescribing algorithms for decreasing polypharmacy (i.e. % of successful deprescribing of at least 1 of the medication classes at 6 month post implementation)
  2. Safety of the deprescribing algorithms using monitoring tools developed for each medication
  3. The impact of the deprescribing tools on patient satisfaction

Methods: In this quasi-experimental interventional cohort study, the nephrology healthcare team will assess medications for all patients as per usual practice in their respective HD units, using the deprescribing algorithms to assist in clinical decision making and patient education tools to explain rationale to patients. Participating patients will be followed for 6 months for outcomes.

The primary outcome will be proportion of individuals successfully deprescribed at least one of the 9 target medications.

Additional outcomes include:

  • Adverse events associated with deprescribing and medication class specific safety outcomes (e.g. for furosemide, the investigators will be tracking blood pressure, potassium, intradialytic weight gain and heart failure admissions)
  • Proportion of identified candidates who began a deprescribing trial
  • Proportion of deprescribing trials declined by medical team and patient, respectively
  • Patient satisfaction (using a patient survey)
  • Average number of medications per patient before/after implementation
  • Average medication cost savings per patient

Expected Results/Impact on Health Research: This study will determine the efficacy of the deprescribing algorithms on reducing polypharmacy in HD patients. It will also provide insights on knowledge translation, as investigators aim to educate providers and patients on the harms of polypharmacy and influence prescribing patterns in HD units nationally. This study will encourage other institutions to incorporate similar tools into their practice and encourage comprehensive and team based re-assessment of patient's medications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • British Colombia
      • Vancouver, British Colombia, Canada, V6Z 1Y6
        • Active, not recruiting
        • Providence Health Care
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 3M3
        • Active, not recruiting
        • Manitoba Renal Program
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Active, not recruiting
        • Nova Scotia Health Authority
    • Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

There will be approximately 1,200 patients in the outpatient HD units from Toronto (300), Vancouver (200), Winnipeg (400) and Halifax (300). Based on a previous pilot study, it is assumed that 80% of patients have been prescribed at least one of the nine target drugs (i.e., n=960). Of those, it is assumed that 50% will be eligible for the study (i.e., n=480). Of eligible individuals, it is assumed 88% will initiate a De-prescribing Trial (Intervention Group), resulting in an anticipated cohort of n=420.

Description

Inclusion Criteria:

  • 18+ years
  • Have been receiving outpatient HD treatment at one of the four study sites for at least the past three months
  • Able to read and understand English and provide consent

Exclusion Criteria:

- Acute starts to HD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Hemodialysis Patients
There will be approximately 1,200 patients in the outpatient HD units from Toronto (300), Vancouver (200), Winnipeg (400) and Halifax (300). Based on a previous pilot study, it is assumed that 80% of patients have been prescribed at least one of the nine target drugs (i.e., n=960). Of those, it is assumed that 50% will be eligible for the study (i.e., n=480). Of eligible individuals, it is assumed 88% will initiate a De-prescribing Trial (Intervention Group), resulting in an anticipated cohort of n=420.
Other: De-prescribing Trial
Validated de-prescribing algorithms will be applied for any patients identified as taking one of the 9 study drugs in order to determine whether or not physician should consider a deprescribing trial. If they are are identified as candidates for deprescribing and consent to participate in the trial, they will enter the Deprescribing Trial group and begin the deprescribing trial.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients who began any of the 9 deprescribing trials who have successfully stayed off that medications by the end of the study
Time Frame: 1 year
Numbers will be given for each of the 9 drug classes and overall
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients who were identified as candidates for a deprescribing trial, after an assessment using one of the nine deprescribing algorithms
Time Frame: 1 year
Numbers will be given for each of the 9 drug classes and overall
1 year
Number of patients who were identified as candidates for a deprescribing trial (after an assessment using one of the nine deprescribing algorithms) but who did not begin a deprescribing trial due to refusal by the medical team
Time Frame: 1 year
Numbers will be given for each of the 9 drug classes and overall
1 year
Number of patients who were identified as candidates for a deprescribing trial (after an assessment using one of the nine deprescribing algorithms) but who did not begin a deprescribing trial due to refusal by the patient
Time Frame: 1 year
Numbers will be given for each of the 9 drug classes and overall
1 year
Change in patient satisfaction scores pre-intervention vs. post-intervention, as assessed by patient satisfaction surveys (developed for this study) administered before the study and 6 months after the study start date
Time Frame: 1 year

The patient satisfaction survey is based on the Consumer Assessment of Healthcare Providers & Systems (CAHPS®) In-Center HD Survey, which rates the medication and dialysis services. Most questions are on a Likert scale ranging from Never (1) to Always (4) or from Strongly Disagree (1) to Strong Agree (5). There are also two No (1) / Yes (2) questions and one 0 (Worst possible) to 10 (Best possible) question. The survey is divided into 3 sections: Dialysis Center Staff, Your Medications, and Deprescribing.

The average total score overall for patients before vs. after the study will be compared (higher scores indicate higher satisfaction). The average total score per section for patients before vs. after the study will also be compared.
1 year
Number of participants with treatment-related adverse events, as assessed by patient monitoring app (developed for this study)
Time Frame: 1 year

The study app will track at adverse events associated with deprescribing each of the specific medication classes. For example: for loopdiuretics, blood pressure, potassium, intradialytic weight gain and heart failure admissions will be tracked; for proton pump inhibitors, gastroesophageal reflux disease (GERD) symptom severity and frequency of antacid use will be tracked

By comparing baseline symptoms to symptoms during and at the completion of deprescribing, safety concerns will be identified.
1 year
Average number of medications (including target medications and any other medications) per patient before and after this deprescribing implementation study
Time Frame: 1 year
Average number of medications (including target medications and any other medications) per patient before and after this deprescribing implementation study
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimated cost savings to the patient and to the healthcare system due to deprescribing initiative
Time Frame: 1 year

The cost of medications that are deprescribed will be calculated based on a yearly supply at the current dose of the patient's therapy. Total costs will be calculated based on current practices for each province. By identifying patients who have their medication costs covered by the healthcare system, it will be possible to determine the medication cost savings to the healthcare system.

For patients who are insured through private insurance plans, or who pay cash for their medications, the provincial formulary cost represents the most conservative approach when calculating the total medication costs. This approach will therefore determine the minimum cost savings to the patient. Overall, both cost savings to the patient and the healthcare system due to deprescribing in HD patients will be determined.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marisa Battistella, PharmD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-5313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease on Dialysis (Diagnosis)

Clinical Trials on De-prescribing Trial

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings