Electronic Decision Support for Deprescribing in Patients on Hemodialysis

NCT05585268 | Completed

• 1 other identifier: 0000
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Renal Disease; Hypertension; Diabete Type 2; Renal Failure Chronic; Anemia; Medication Interaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean number of total medications

  1 month

Study Arms (2)

MedSafer-supplemented medication reconciliation

ACTIVE COMPARATOR

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.

Other: Medication reconciliation supplemented with MedSafer and deprescribing brochures

Standard of care medication reconciliation

NO INTERVENTION

This unit will serve as the control unit where standard of care will be provided and no deprescribing reports nor brochures will be delivered. MedSafer reports will be generated but withheld from the clinical team. This will serve as a comparator to determine if the intervention unit was more successful in deprescribing compared to this control unit.

Interventions

Medication reconciliation supplemented with MedSafer and deprescribing brochures OTHER

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.

MedSafer-supplemented medication reconciliation

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older
• On outpatient maintenance hemodialysis
• On one of the study units

You may not qualify if:

• Patient is hospitalized during the period of the intervention
• Patient is newly initiated on hemodialysis during the intervention

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (12)

• 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.

  PMID: 32426145 BACKGROUND

• 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.

  PMID: 35586025 BACKGROUND

• 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.

  PMID: 29568537 BACKGROUND

• 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.

  PMID: 30046021 BACKGROUND

• 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.

  PMID: 32056163 BACKGROUND

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

  PMID: 31259501 BACKGROUND

• 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.

  PMID: 22500536 BACKGROUND

• 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.

  PMID: 35040926 BACKGROUND

• 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.

  PMID: 34727956 BACKGROUND

• 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.

  PMID: 31250427 BACKGROUND

• 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.

  PMID: 28416321 BACKGROUND

• Bortolussi-Courval E, Podymow T, Trinh E, Moryousef J, Hanula R, Huon JF, Mavrakanas T, Suri R, Lee TC, McDonald EG. Electronic Decision Support for Deprescribing in Patients on Hemodialysis: Clinical Research Protocol for a Prospective, Controlled, Quality Improvement Study. Can J Kidney Health Dis. 2023 Jun 26;10:20543581231165712. doi: 10.1177/20543581231165712. eCollection 2023.

  PMID: 37435299 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Hypertension; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Emily McDonald, MD MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: This quality improvement, parallel group, superiority trial will use two different dialysis sites of the McGill University Health Centre. One unit will act as a control unit. The other will act as an intervention unit. Participants are automatically enrolled in the study and assigned to the intervention when the MedSafer reports are handed to the clinical team at the time of performing a medication reconciliation.

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 18, 2022
• Study Start: October 3, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1-year after publication of the main trial
• Access Criteria: Contact the primary investigator at emily.mcdonald@mcgill.ca; a data sharing agreement will need to be in place.

Locations

CA (1)