Recruiting

Targeted Deprescribing

Sponsor:

University Health Network, Toronto

Code:

NCT03733262

Conditions

End Stage Renal Disease on Dialysis (Diagnosis)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

De-prescribing Trial

Study Details

Brief summary:

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.

Conditions

End Stage Renal Disease on Dialysis (Diagnosis)

Study ID

NCT03733262

Start date

Oct 1, 2022

Status verified date

May, 2024

Completion date

Mar 30, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

480 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 13, 2024

Last verified

May, 2024

Keywords

  • deprescribing
  • hemodialysis
  • medication optimization
  • medication prescribing patterns
  • patient safety
  • polypharmacy
  • pill burden
  • quality improvement activity
  • chronic kidney disease
  • end-stage renal disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2024-12-13.