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

Abstract

Background: Patients on dialysis are commonly prescribed multiple medications (polypharmacy), many of which are potentially inappropriate medications (PIMs). Potentially inappropriate medications are associated with an increased risk of falls, fractures, and hospitalization. MedSafer is an electronic tool that generates individualized, prioritized reports with deprescribing opportunities by cross-referencing patient health data and medications with guidelines for deprescribing. Objectives: Our primary aim was to increase deprescribing, as compared with usual care (medication reconciliation or MedRec), for outpatients receiving maintenance hemodialysis, through the provision of MedSafer deprescribing opportunity reports to the treating team and patient empowerment deprescribing brochures provided directly to the patients themselves. Design: This controlled, prospective, quality improvement study with a contemporary control builds on existing policy at the outpatient hemodialysis centers where biannual MedRecs are performed by the treating nephrologist and nursing team. Setting: The study takes place on 2 of the 3 outpatient hemodialysis units of the McGill University Health Centre in Montreal, Quebec, Canada. The intervention unit is the Lachine Hospital, and the control unit is the Montreal General Hospital. Patients: A closed cohort of outpatient hemodialysis patients visit one of the hemodialysis centers multiple times per week for their hemodialysis treatment. The initial cohort of the intervention unit includes 85 patients, whereas the control unit has 153 patients. Patients who are transplanted, hospitalized during their scheduled MedRec, or die before or during the MedRec will be excluded from the study. Measurements: We will compare rates of deprescribing between the control and intervention units following a single MedRec. On the intervention unit, MedRecs will be paired with MedSafer reports (the intervention), and on the control unit, MedRecs will take place without MedSafer reports (usual care). On the intervention unit, patients will also receive deprescribing patient empowerment brochures for select medication classes (gabapentinoids, proton-pump inhibitors, sedative hypnotics and opioids for chronic non-cancer pain). Physicians on the intervention unit will be interviewed post-MedRec to determine implementation barriers and facilitators. Methods: The primary outcome will be the proportion of patients with 1 or more PIMs deprescribed on the intervention unit, as compared with the control unit, following a biannual MedRec. This study will build on existing policies aimed at optimizing medication therapy in patients undergoing maintenance hemodialysis. The electronic deprescribing decision support tool, MedSafer, will be tested in a dialysis setting, where nephrologists are regularly in contact with patients. MedRecs are an interdisciplinary clinical activity performed biannually on the hemodialysis units (in the Spring and Fall), and within 1 week following discharge from any hospitalization. This study will take place in the Fall of 2022. Semi-structured interviews will be conducted among physicians on the intervention unit to determine barriers and facilitators to implementation of the MedSafer-supplemented MedRec process and analyzed according to grounded theory in qualitative research. Limitations: Deprescribing can be limited due to nephrologists’ time constraints, cognitive impairment of the hemodialyzed patient stemming from their illness and complex medication regimens, and lack of sufficient patient resources to learn about the medications they are taking and their potential harms. Conclusions: Electronic decision support can facilitate deprescribing for the clinical team by providing a nudge reminder, decreasing the time it takes to review and effectuate guideline recommendations, and by lowering the barrier of when and how to taper. Guidelines for deprescribing in the dialysis population have recently been published and incorporated into the MedSafer software. To our knowledge, this will be the first study to examine the efficacy of pairing these guidelines with MedRecs by leveraging electronic decision support in the outpatient dialysis population. Trial registration: This study was registered on Clinicaltrials.gov (NCT05585268) on October 2, 2022, prior to the enrolment of the first participant on October 3, 2022. The registration number is pending at the time of protocol submission.

Medication Deprescribing in Patients Receiving Hemodialysis: A Prospective Controlled Quality Improvement Study

“…The detailed protocol for this study was published previously. 26 The intervention unit was the Lachine Hospital dialysis unit, and the control unit was the Montreal General Hospital dialysis unit. The physician-champion randomly assigned these units.…”

“…29 Our a priori sample size calculation suggested we would have 80% power to demonstrate at least a 15% increase in the proportion of patients with 1 or more PIMs deprescribed. 26 …”

Deprescribing in Dialysis: Operationalizing “Less is More” Through a Multimodal Deprescribing Intervention

“…In this issue of Kidney Medicine , Bortolussi-Courval et al 14 report their findings from a prospective, nonrandomized controlled quality improvement study conducted across 2 dialysis centers in Montreal, Canada, conducted between September and December 2022, with one facility serving as the intervention site and the other as a control site. The authors compared the impact of MedSafer (n=68) versus traditional biannual medication reconciliation (n=127) on PIM deprescribing among outpatient dialysis patients who were prescribed a median of 4 PIMs on both the control and intervention units and >14 medications overall.…”

“…The authors compared the impact of MedSafer (n=68) versus traditional biannual medication reconciliation (n=127) on PIM deprescribing among outpatient dialysis patients who were prescribed a median of 4 PIMs on both the control and intervention units and >14 medications overall. 14 MedSafer is evidence-based, algorithm-driven intervention for effective deprescribing whereby patients’ electronic health record data are extracted and cross-referenced against evidence-based guidelines to generate stratified reports listing PIMs based on their risk level (high, intermediate, and low) of developing an adverse drug event (ADE). Notably, in this study patients in the intervention group also received EMPOWER reports, which provided direct tailored feedback regarding select PIMs identified for deprescribing from their own medical record.…”

“…The Practical Robust Implementation and Sustainability Model framework accounts for the multilevel factors required for implementation success including diverse and variable user characteristics (eg, patient and clinician characteristics), and the external environment (eg, shifting clinical practice guidelines). 16 Bortolussi-Courval et al 14 provide multiple examples of how to enhance intervention success through careful implementation that addresses several elements of the Practical Robust Implementation and Sustainability Model. For instance, MedSafer’s success in this context may have been enhanced through the adaption a deployed evidence-based intervention, 12 , 13 which directly address barriers known to affect dialysis deprescribing (eg, nephrologist time to collect and reconcile medications manually, EMPOWER brochures delivered to patients with accessible language regarding PIM risks and benefits).…”