Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT05585268
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.
Study:
NCT05585268
Study Brief:
Protocol Section:
NCT05585268