Targeted Deprescribing in Patients on Hemodialysis

NCT03733262 | Recruiting

• 1 other identifier: 17-5313
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 4

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of patients who began any of the 9 deprescribing trials who have successfully stayed off that medications by the end of the study

  Numbers will be given for each of the 9 drug classes and overall

  1 year

Secondary Outcomes (6)

• Number of patients who were identified as candidates for a deprescribing trial, after an assessment using one of the nine deprescribing algorithms

  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

  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

  1 year

• Average number of medications (including target medications and any other medications) per patient before and after this deprescribing implementation study

  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

  1 year

Other Outcomes (1)

• Estimated cost savings to the patient and to the healthcare system due to deprescribing initiative

  1 year

Study Arms (1)

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

Interventions

De-prescribing Trial OTHER

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.

Hemodialysis Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• + 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

You may not qualify if:

• \- Acute starts to HD

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (4)

Providence Health Care

Vancouver, British Colombia, V6Z 1Y6, Canada

ACTIVE NOT RECRUITING

Manitoba Renal Program

Winnipeg, Manitoba, R2V 3M3, Canada

ACTIVE NOT RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

ACTIVE NOT RECRUITING

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (1)

• Zlotnik N, Abbaticchio A, Theodorlis M, Cross MS, Kitchlu A, Wilson JA, Gagliardi AR, Battistella M. Medication Mindfulness: Implementation and Evaluation of a Single-Site, 6-Month Deprescribing Intervention for Patients on Hemodialysis. Kidney360. 2025 Dec 1;6(12):2196-2207. doi: 10.34067/KID.0000000884. Epub 2025 Jun 26.

  PMID: 40569679 DERIVED

MeSH Terms

Conditions

Disease; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Marisa Battistella, PharmD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisa Battistella, PharmD

CONTACT

416-340-4800; marisa.battistella@uhn.ca

Melissa Lefebvre, MBiotech

CONTACT

416-858-9786; melissa.lefebvre@uhnresearch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy Clinician Scientist

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 7, 2018
• Study Start: October 1, 2022
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)