Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-28 @ 3:47 AM
Study NCT ID:
NCT05585268
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2022-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Decision Support for Deprescribing in Patients on Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2022-10-02', 'studyFirstSubmitQcDate': '2022-10-15', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with one or more PIMs deprescribed', 'timeFrame': '1 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean number of total medications', 'timeFrame': '1 month', 'description': 'The reduction in the mean number of drugs taken following a medication reconciliation compared between intervention and control unit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease', 'Hypertension', 'Diabete Type 2', 'Renal Failure Chronic', 'Anemia', 'Medication Interaction']}, 'referencesModule': {'references': [{'pmid': '32426145', 'type': 'BACKGROUND', '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.'}, {'pmid': '35586025', 'type': 'BACKGROUND', '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.'}, {'pmid': '29568537', 'type': 'BACKGROUND', '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.'}, {'pmid': '30046021', 'type': 'BACKGROUND', 'citation': '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': '32056163', 'type': 'BACKGROUND', '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.'}, {'pmid': '31259501', 'type': 'BACKGROUND', 'citation': 'Halli-Tierney AD, Scarbrough C, Carroll D. Polypharmacy: Evaluating Risks and Deprescribing. Am Fam Physician. 2019 Jul 1;100(1):32-38.'}, {'pmid': '22500536', 'type': 'BACKGROUND', '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.'}, {'pmid': '35040926', 'type': 'BACKGROUND', '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.'}, {'pmid': '34727956', 'type': 'BACKGROUND', '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.'}, {'pmid': '31250427', 'type': 'BACKGROUND', '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.'}, {'pmid': '28416321', 'type': 'BACKGROUND', '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.'}, {'pmid': '37435299', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOver 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.\n\nStudies 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.\n\nObjectives 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* On outpatient maintenance hemodialysis\n* On one of the study units\n\nExclusion Criteria:\n\n* Patient is hospitalized during the period of the intervention\n* Patient is newly initiated on hemodialysis during the intervention'}, 'identificationModule': {'nctId': 'NCT05585268', 'acronym': 'MedSafer-HD', 'briefTitle': 'Electronic Decision Support for Deprescribing in Patients on Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Electronic Decision Support for Deprescribing in Patients on Hemodialysis: a Prospective, Controlled, Quality Improvement Study', 'orgStudyIdInfo': {'id': '0000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MedSafer-supplemented medication reconciliation', 'description': '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.', 'interventionNames': ['Other: Medication reconciliation supplemented with MedSafer and deprescribing brochures']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care medication reconciliation', 'description': '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': [{'name': 'Medication reconciliation supplemented with MedSafer and deprescribing brochures', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['MedSafer-supplemented medication reconciliation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Emily McDonald, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '1-year after publication of the main trial', 'ipdSharing': 'YES', 'description': 'Anonymous data will be made available for secondary analysis upon request with a data sharing agreement', 'accessCriteria': 'Contact the primary investigator at emily.mcdonald@mcgill.ca; a data sharing agreement will need to be in place.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Emily McDonald', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}