Electronic Decision Support for Deprescribing in Patients on Hemodialysis

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Medication reconciliation supplemented with MedSafer and deprescribing brochures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MedSafer-supplemented medication reconciliation<br>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<br>* 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.<br>|
| No Intervention: Standard of care medication reconciliation<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |