An electronic pillbox intervention designed to improve medication safety during care transitions: challenges and lessons learned regarding implementation and evaluation.

BACKGROUND: Adverse drug events are common during transitions of care. As part of the Smart Pillbox study, a cluster-randomized controlled trial of an electronic pillbox designed to reduce medication discrepancies and improve medication adherence after hospital discharge, we explored barriers to successful implementation and evaluation of this intervention. METHODS: Eligible patients were those admitted to a medicine service of a large teaching hospital with a plan to be discharged home on five or more chronic medications. The intervention consisted of an electronic pillbox with pre-filled weekly blister pack medication trays given to patients prior to discharge. Pillbox features included alarms to take medications, detection of pill removal from each well, alerts to patients or caregivers by phone, email, or text if medications were not taken, and adherence reports accessible by providers. Greater than 20% missed doses for three days in a row triggered outreach from a pharmacist. To identify barriers to implementation and evaluation of the intervention, we reviewed patient exit surveys, including quantitative data on satisfaction and free-text responses regarding their experiences; technical issue logs; and team meeting minutes. Themes were derived by consensus among the study authors and organized using the Consolidated Framework for Implementation Research. RESULTS: Barriers to implementation included intervention characteristics such as perceived portability issues with the pillbox and time required by pharmacists to enter medication information into the software; external policies such as lack of insurance coverage for early refills and regulatory prohibitions on repackaging medications; implementation climate issues such as the incompatibility between the rushed nature of hospital discharge with the time required to deploy the intervention; and patient issues such as denial of previous problems with medication adherence. We founds several obstacles to conducting the study, including patients declining study enrollment and limited attempts by the hospital to streamline logistics by building the intervention into usual care. Several solutions to address many of these challenges were implemented or planned. Despite these challenges, many patients with the pillbox were pleased with the service and believed the intervention worked well for them. CONCLUSIONS: In this evaluation, several barriers to implementing and conducting a study of the effectiveness of the intervention were identified. Our findings provide lessons learned for others wishing to implement and evaluate HIT-related interventions designed to improve medication safety during care transitions. TRIAL REGISTRATION: Clinicaltrials.gov NCT03475030.

Design of MARQUIS2: study protocol for a mentored implementation study of an evidence-based toolkit to improve patient safety through medication reconciliation.

BACKGROUND: The first Multi-center Medication Reconciliation Quality Improvement Study (MARQUIS1) demonstrated that implementation of a medication reconciliation best practices toolkit decreased total unintentional medication discrepancies in five hospitals. We sought to implement the MARQUIS toolkit in more diverse hospitals, incorporating lessons learned from MARQUIS1. METHODS: MARQUIS2 is a pragmatic, mentored implementation QI study which collected clinical and implementation outcomes. Sites implemented a revised toolkit, which included interventions from these domains: 1) best possible medication history (BPMH)-taking; 2) discharge medication reconciliation and patient/caregiver counseling; 3) identifying and defining clinician roles and responsibilities; 4) risk stratification; 5) health information technology improvements; 6) improved access to medication sources; 7) identification and correction of real-time discrepancies; and, 8) stakeholder engagement. Eight hospitalists mentored the sites via one site visit and monthly phone calls over the 18-month intervention period. Each site's local QI team assessed opportunities to improve, implemented at least one of the 17 toolkit components, and accessed a variety of resources (e.g. implementation manual, webinars, and workshops). Outcomes to be assessed will include unintentional medication discrepancies per patient. DISCUSSION: A mentored multi-center medication reconciliation QI initiative using a best practices toolkit was successfully implemented across 18 medical centers. The 18 participating sites varied in size, teaching status, location, and electronic health record (EHR) platform. We introduce barriers to implementation and lessons learned from MARQUIS1, such as the importance of utilizing dedicated, trained medication history takers, simple EHR solutions, clarifying roles and responsibilities, and the input of patients and families when improving medication reconciliation.

What works in medication reconciliation: an on-treatment and site analysis of the MARQUIS2 study.

BACKGROUND: The second Multicenter Medication Reconciliation Quality Improvement Study demonstrated a marked reduction in medication discrepancies per patient. The aim of the current analysis was to determine the association of patient exposure to each system-level intervention and receipt of each patient-level intervention on these results. METHODS: This study was conducted at 17 North American Hospitals, the study period was 18 months per site, and sites typically adopted interventions after 2-5 months of preintervention data collection. We conducted an on-treatment analysis (ie, an evaluation of outcomes based on patient exposure) of system-level interventions, both at the category level and at the individual component level, based on monthly surveys of implementation site leads at each site (response rate 65%). We then conducted a similar analysis of patient-level interventions, as determined by study pharmacist review of documented activities in the medical record. We analysed the association of each intervention on the adjusted number of medication discrepancies per patient in admission and discharge orders, based on a random sample of up to 22 patients per month per site, using mixed-effects Poisson regression with hospital site as a random effect. We then used a generalised linear mixed-effects model (GLMM) decision tree to determine which patient-level interventions explained the most variance in discrepancy rates. RESULTS: Among 4947 patients, patient exposure to seven of the eight system-level component categories was associated with modest but significant reductions in discrepancy rates (adjusted rate ratios (ARR) 0.75-0.97), as were 15 of the 17 individual system-level intervention components, including hiring, reallocating and training personnel to take a best possible medication history (BPMH) and training personnel to perform discharge medication reconciliation and patient counselling. Receipt of five of seven patient-level interventions was independently associated with large reductions in discrepancy rates, including receipt of a BPMH in the emergency department (ED) by a trained clinician (ARR 0.40, 95% CI 0.37 to 0.43), admission medication reconciliation by a trained clinician (ARR 0.57, 95% CI 0.50 to 0.64) and discharge medication reconciliation by a trained clinician (ARR 0.64, 95% CI 0.57 to 0.73). In GLMM decision tree analyses, patients who received both a BPMH in the ED and discharge medication reconciliation by a trained clinician experienced the lowest discrepancy rates (0.08 per medication per patient). CONCLUSION AND RELEVANCE: Patient-level interventions most associated with reductions in discrepancies were receipt of a BPMH of admitted patients in the ED and admission and discharge medication reconciliation by a trained clinician. System-level interventions were associated with modest reduction in discrepancies for the average patient but are likely important to support patient-level interventions and may reach more patients. These findings can be used to help hospitals and health systems prioritise interventions to improve medication safety during care transitions.

Effects of a refined evidence-based toolkit and mentored implementation on medication reconciliation at 18 hospitals: results of the MARQUIS2 study.

BACKGROUND: The first Multicenter Medication Reconciliation Quality Improvement (QI) Study (MARQUIS1) demonstrated that mentored implementation of a medication reconciliation best practices toolkit decreased total unintentional medication discrepancies in five hospitals, but results varied by site. The objective of this study was to determine the effects of a refined toolkit on a larger group of hospitals. METHODS: We conducted a pragmatic quality improvement study (MARQUIS2) at 18 North American hospitals or hospital systems from 2016 to 2018. Incorporating lessons learnt from MARQUIS1, we implemented a refined toolkit, offering 17 system-level and 6 patient-level interventions. One of eight physician mentors coached each site via monthly calls and performed one to two site visits. The primary outcome was number of unintentional medication discrepancies in admission or discharge orders per patient. Time series analysis used multivariable Poisson regression. RESULTS: A total of 4947 patients were sampled, including 1229 patients preimplementation and 3718 patients postimplementation. Both the number of system-level interventions adopted per site and the proportion of patients receiving patient-level interventions increased over time. During the intervention, patients experienced a steady decline in their medication discrepancy rate from 2.85 discrepancies per patient to 0.98 discrepancies per patient. An interrupted time series analysis of the 17 sites with sufficient data for analysis showed the intervention was associated with a 5% relative decrease in discrepancies per month over baseline temporal trends (adjusted incidence rate ratio: 0.95, 95% CI 0.93 to 0.97, p<0.001). Receipt of patient-level interventions was associated with decreased discrepancy rates, and these associations increased over time as sites adopted more system-level interventions. CONCLUSION: A multicentre medication reconciliation QI initiative using mentored implementation of a refined best practices toolkit, including patient-level and system-level interventions, was associated with a substantial decrease in unintentional medication discrepancies over time. Future efforts should focus on sustainability and spread.