Electronic Decision Support for Deprescribing in Patients on Hemodialysis

Hypertension Clinical Trial

— MedSafer-HD  

Official title:

Electronic Decision Support for Deprescribing in Patients on Hemodialysis: a Prospective, Controlled, Quality Improvement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05585268
• Other study ID #: 0000
• Status: Completed
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dialysis patients are prescribed an average of 10-12 medications per day, from up to 4-5 different clinicians and have the heaviest pill burden of all chronic conditions given their degree of comorbidity. One strategy for addressing the problem of "medication overload" is through scalable deprescribing interventions. MedSafer is an electronic deprescribing tool that cross-references patient health data with existing deprescribing guidelines and provides a deprescribing report to clinicians to facilitate deprescribing and reducing the burden of polypharmacy. In this study the investigators will test MedSafer on dialysis patients paired with medication reconciliation on an intervention unit compared to a control unit.

Description:

Patients on dialysis are prescribed an average of 10-12 medications per day from up to 4-5 different clinicians and amounting to up to 19 pills per day. This patient population has one of the the heaviest pill burdens of all chronic conditions because of therapy to treat comorbidities like disease, hypertension, or diabetes as well as therapy directed at symptoms and drug side effects.

Over 90% of hemodialysis patients take 5 or more medications (polypharmacy), contributing to medication overload. Further, up to 50% of patients on dialysis are prescribed a potentially inappropriate medication (PIM), defined as a medication carrying an increased risk of contributing to an adverse drug event (ADE). Polypharmacy and associated ADEs increase emergency room visits, hospital admissions and the risk of premature death. Furthermore, some medications have little therapeutic benefit and simply add to pill burden.

Studies continue to document the pressing need for deprescribing, medication reconciliation, and medication management programs in dialysis patient populations for the above reasons. While deprescribing guidelines are available to clinicians, they can be difficult to implement as few tools consolidate the recommendations, guidelines are often long lists which require memorization, and they may not explain how to deprescribe and what rebound symptoms to watch out for. The investigators have previously demonstrated that the electronic tool MedSafer, which identifies deprescribing opportunities based on comparing medication lists and comorbidities to a curated ruleset which incorporates publicly available deprescribing guidance and emerging literature, can be a valuable aid in supporting deprescription of PIMs during acute care episodes. MedSafer has also been shown to be of benefit in Long Term Care settings. Dialysis patients, with a large burden of polypharmacy and complex medical histories, coupled with a high risk for adverse drug events leading to hospitalization and death, represent a unique population in which to study a systematic deprescribing intervention as a means of improving quality of care.

Objectives The primary aim is to provide deprescribing reports containing MedSafer recommendations to the clinical team of a hemodialysis unit during the process of Medication reconciliation, to determine if the identification of deprescribing opportunities can improve medication appropriateness as defined by the receipt of potentially inappropriate medications (PIMs) at the patient level. This intervention will be compared to the efficacy of the intervention with a control dialysis unit that will undergo the standard of care medication reconciliation process with a MedSafer report.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years and older

• On outpatient maintenance hemodialysis

• On one of the study units

Exclusion Criteria:

• Patient is hospitalized during the period of the intervention

• Patient is newly initiated on hemodialysis during the intervention

Related Conditions & MeSH terms

• Anemia
• Diabete Type 2
• Diabetes Mellitus, Type 2
• End Stage Renal Disease
• Hypertension
• Kidney Failure, Chronic
• Renal Failure Chronic

Intervention

Other:
• Medication reconciliation supplemented with MedSafer and deprescribing brochures
This unit will act as an intervention unit for the MedRec where MedSafer deprescribing reports will be handed to the treating team and deprescribing brochures from the Canadian Deprescribing Network will be given to patients.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (11)

Alshamrani M, Almalki A, Qureshi M, Yusuf O, Ismail S. Polypharmacy and Medication-Related Problems in Hemodialysis Patients: A Call for Deprescribing. Pharmacy (Basel). 2018 Jul 25;6(3):76. doi: 10.3390/pharmacy6030076. — View Citation

Battistella M, Jandoc R, Ng JY, McArthur E, Garg AX. A Province-wide, Cross-sectional Study of Demographics and Medication Use of Patients in Hemodialysis Units Across Ontario. Can J Kidney Health Dis. 2018 Mar 13;5:2054358118760832. doi: 10.1177/2054358118760832. eCollection 2018. — View Citation

Halli-Tierney AD, Scarbrough C, Carroll D. Polypharmacy: Evaluating Risks and Deprescribing. Am Fam Physician. 2019 Jul 1;100(1):32-38. — View Citation

Hovstadius B, Petersson G. Factors leading to excessive polypharmacy. Clin Geriatr Med. 2012 May;28(2):159-72. doi: 10.1016/j.cger.2012.01.001. Epub 2012 Feb 15. — View Citation

Marin JG, Beresford L, Lo C, Pai A, Espino-Hernandez G, Beaulieu M. Prescription Patterns in Dialysis Patients: Differences Between Hemodialysis and Peritoneal Dialysis Patients and Opportunities for Deprescription. Can J Kidney Health Dis. 2020 May 1;7:2054358120912652. doi: 10.1177/2054358120912652. eCollection 2020. — View Citation

McDonald EG, Wu PE, Rashidi B, Forster AJ, Huang A, Pilote L, Papillon-Ferland L, Bonnici A, Tamblyn R, Whitty R, Porter S, Battu K, Downar J, Lee TC. The MedSafer Study: A Controlled Trial of an Electronic Decision Support Tool for Deprescribing in Acute Care. J Am Geriatr Soc. 2019 Sep;67(9):1843-1850. doi: 10.1111/jgs.16040. Epub 2019 Jun 27. — View Citation

McDonald EG, Wu PE, Rashidi B, Wilson MG, Bortolussi-Courval E, Atique A, Battu K, Bonnici A, Elsayed S, Wilson AG, Papillon-Ferland L, Pilote L, Porter S, Murphy J, Ross SB, Shiu J, Tamblyn R, Whitty R, Xu J, Fabreau G, Haddad T, Palepu A, Khan N, McAlister FA, Downar J, Huang AR, MacMillan TE, Cavalcanti RB, Lee TC. The MedSafer Study-Electronic Decision Support for Deprescribing in Hospitalized Older Adults: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):265-273. doi: 10.1001/jamainternmed.2021.7429. — View Citation

McIntyre C, McQuillan R, Bell C, Battistella M. Targeted Deprescribing in an Outpatient Hemodialysis Unit: A Quality Improvement Study to Decrease Polypharmacy. Am J Kidney Dis. 2017 Nov;70(5):611-618. doi: 10.1053/j.ajkd.2017.02.374. Epub 2017 Apr 14. — View Citation

Moryousef J, Bortolussi-Courval E, Podymow T, Lee TC, Trinh E, McDonald EG. Deprescribing Opportunities for Hospitalized Patients With End-Stage Kidney Disease on Hemodialysis: A Secondary Analysis of the MedSafer Cluster Randomized Controlled Trial. Can J Kidney Health Dis. 2022 May 13;9:20543581221098778. doi: 10.1177/20543581221098778. eCollection 2022. — View Citation

Nadeau ME, Henry JL, Lee TC, Bortolussi-Courval E, Goodine C, McDonald EG. Spread and scale of an electronic deprescribing software to improve health outcomes of older adults living in nursing homes: study protocol for a stepped wedge cluster randomized trial. Trials. 2021 Nov 2;22(1):763. doi: 10.1186/s13063-021-05729-0. — View Citation

Sommer J, Seeling A, Rupprecht H. Adverse Drug Events in Patients with Chronic Kidney Disease Associated with Multiple Drug Interactions and Polypharmacy. Drugs Aging. 2020 May;37(5):359-372. doi: 10.1007/s40266-020-00747-0. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with one or more PIMs deprescribed	The proportion of participants with one or more PIMs deprescribed following a medication reconciliation, compared between intervention and control units.This will be conditioned on patients with 1 or more PIMs at baseline.	1 month
Secondary	Mean number of total medications	The reduction in the mean number of drugs taken following a medication reconciliation compared between intervention and control unit	1 month