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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Nova Scotia Health Authority
ACTIVE_NOT_RECRUITING
Halifax
University Health Network
RECRUITING
Toronto
Providence Health Care
ACTIVE_NOT_RECRUITING
Vancouver
Manitoba Renal Program
ACTIVE_NOT_RECRUITING
Winnipeg
Contact Information
Primary
Marisa Battistella, PharmD
marisa.battistella@uhn.ca
416-340-4800
Backup
Melissa Lefebvre, MBiotech
melissa.lefebvre@uhnresearch.ca
416-858-9786
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 480
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov