Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
480 participants
OBSERVATIONAL
2022-10-01
2026-03-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Marisa Battistella
Pharmacy Clinician Scientist
Principal Investigators
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Marisa Battistella, PharmD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Providence Health Care
Vancouver, British Colombia, Canada
Manitoba Renal Program
Winnipeg, Manitoba, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Marisa Batistella, PharmD
Role: primary
Melissa Lefebvre, MBiotech
Role: backup
Other Identifiers
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17-5313
Identifier Type: -
Identifier Source: org_study_id