Targeted Deprescribing in Patients on Hemodialysis

End Stage Renal Disease on Dialysis (Diagnosis) Clinical Trial

Official title:

Implementation of Deprescribing and Patient Education Tools In Hemodialysis Units To Decrease Polypharmacy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03733262
• Other study ID #: 17-5313
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: November 2020
• Source: University Health Network, Toronto
• Contact: Marisa Battistella, PharmD
• Phone: 416-340-4800
• Email: marisa.battistella[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis (Diagnosis)
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	University Health Network	Toronto	Ontario
Canada	Providence Health Care	Vancouver	British Colombia
Canada	Manitoba Renal Program	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated cost savings to the patient and to the healthcare system due to deprescribing initiative	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
Primary	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	Number of patients who were identified as candidates for a deprescribing trial, after an assessment using one of the nine deprescribing algorithms	Numbers will be given for each of the 9 drug classes and overall	1 year
Secondary	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	Numbers will be given for each of the 9 drug classes and overall	1 year
Secondary	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	Numbers will be given for each of the 9 drug classes and overall	1 year
Secondary	Average number of medications (including target medications and any other medications) per patient before and after this deprescribing implementation study		1 year
Secondary	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	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
Secondary	Number of participants with treatment-related adverse events, as assessed by patient monitoring app (developed for this study)	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