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.

Risks of Development of COVID-19 Among Patients With Inflammatory Bowel Disease: A Comparative Assessment of Risk Factors for Incident Infection.

Background: Patients with inflammatory bowel disease (IBD) may be at risk for development of COVID-19 infection due to innate immune dysfunction and/or immunosuppressive medication use. Methods: In a prospective cohort of adult IBD patients, we captured data on clinical risk factors and IBD medication utilization. The outcome of interest was development of patient-reported laboratory confirmed COVID-19. We calculated incidence rate and performed bivariate analyses to describe the effects of risk factors (age, immunosuppression use, obesity, and race) on development of COVID-19. We utilized logistic regression models to determine the independent risks associated with each factor. Results: A total of 3953 patients with IBD were followed for a mean duration of 212 days (SD 157). A total of 103 individuals developed COVID-19 during follow-up (2.6%, rate of 45 per 1000 person-years). Severity of infection was generally mild. Clinical characteristics were similar among those who developed COVID-19 as compared to not. African American race was associated with incident COVID-19 infection (OR 3.37, 95% CI 1.18-9.59). Immunosuppression use was not associated with development of COVID-19 (OR 1.19, 95% CI 0.72-1.75), nor was age (OR 1.00, 95% CI 0.99-1.02), nor obesity (OR 1.01, 95% CI 0.61-1.66). Conclusions: Immunosuppression use did not increase the risk of development of COVID-19. Therapeutic management of IBD should not be altered to prevent a risk of developing COVID-19.

A Patient-Prioritized Agenda for Information Needs During the COVID-19 Pandemic: A Qualitative Study of Patients With Inflammatory Bowel Disease.

BACKGROUND: Patients with inflammatory bowel disease (IBD) may be at risk for complications due to the COVID-19 pandemic. We performed a qualitative study to better understand IBD patient experiences and concerns when navigating the COVID-19 pandemic, with the goal of prioritizing patients' information needs. METHODS: We conducted a series of semistructured virtual focus groups at 6 months, then member checking focus groups 1 year into the COVID-19 pandemic. We included questions on patients' experiences navigating the pandemic with IBD, differences in their experience as compared to peers, their concerns and fears, as well as preferred information sources. Transcribed focus groups were coded and content analyzed to summarize key areas of interest and identify themes. We focused on 4 areas in our content analysis process: fears, challenges, information preferences, and research questions. RESULTS: A total of 26 IBD patient participants were included in the initial focus groups. Findings highlighted the many challenges faced by patients during the COVID-19 pandemic, ranging from access (bathrooms, medications, healthcare) to significant fears and concerns surrounding medications used for IBD worsening risks of COVID-19. Research questions of importance to patients centered on understanding risks for COVID-19 complications, particularly pertaining to medication utilization, with a shift over time toward understanding COVID-19 vaccination. In our member checking focus groups (n = 8 participants), themes were reiterated, with a central focus of research questions pertaining to COVID-19 vaccination. CONCLUSIONS: Information needs for patients during the COVID-19 pandemic centered upon understanding disease-specific risks. Identified challenges and fears will inform future research agendas and communication with patients.

Patient-Powered Research Networks of the Autoimmune Research Collaborative: Rationale, Capacity, and Future Directions.

Patient-Powered Research Networks (PPRNs) are US-based registry infrastructures co-created by advocacy groups, patient research partners, academic investigators, and other healthcare stakeholders. Patient-Powered Research Networks collect information directly from patients to conduct and disseminate the results of patient-centered/powered research that helps patients make more informed decisions about their healthcare. Patient-Powered Research Networks gather and utilize real-world data and patient-reported outcomes to conduct comparative effectiveness, safety, and other research, and leverage the Internet to accomplish this effectively and efficiently. Four PPRNs focused on autoimmune and immune-mediated conditions formed the Autoimmune Research Collaborative: ArthritisPower (rheumatoid arthritis, spondyloarthritis, and other rheumatic and musculoskeletal diseases), IBD Partners (inflammatory bowel disease), iConquerMS (multiple sclerosis), and the Vasculitis PPRN (vasculitis). The Autoimmune Research Collaborative aims to inform the healthcare decision making of patients, care partners, and other stakeholders, such as clinicians, regulators, and payers. Illustrated by practical applications from the Autoimmune Research Collaborative and its constituent PPRNs, this article discusses the shared capacities and challenges of the PPRN model, and the opportunities presented by collaborating across autoimmune conditions to design, conduct, and disseminate patient-centered outcomes research.