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Electronic Decision Support for Deprescribing in Patients on Hemodialysis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05585268
Acronym
MedSafer-HD
Enrollment
195
Registered
2022-10-18
Start date
2022-10-03
Completion date
2022-12-01
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed 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.

Interventions

OTHERMedication 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.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with one or more PIMs deprescribed1 monthThe 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.

Secondary

MeasureTime frameDescription
Mean number of total medications1 monthThe reduction in the mean number of drugs taken following a medication reconciliation compared between intervention and control unit

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026