Effectiveness of Bio-K+ for the prevention of Clostridioides difficile infection: Stepped-wedge cluster-randomized controlled trial.

OBJECTIVE: To evaluate the impact of administering probiotics to prevent Clostridioides difficile infection (CDI) among patients receiving therapeutic antibiotics. DESIGN: Stepped-wedge cluster-randomized trial between September 1, 2016, and August 31, 2019. SETTING: This study was conducted in 4 acute-care hospitals across an integrated health region. PATIENTS: Hospitalized patients, aged ≥55 years. METHODS: Patients were given 2 probiotic capsules daily (Bio-K+, Laval, Quebec, Canada), containing 50 billion colony-forming units of Lactobacillus acidophilus CL1285, L. casei LBC80R, and L. rhamnosus CLR2. We measured hospital-acquired CDI (HA-CDI) and the number of positive C. difficile tests per 10,000 patient days as well as adherence to administration of Bio-K+ within 48 and 72 hours of antibiotic administration. Mixed-effects generalized linear models, adjusted for influenza admissions and facility characteristics, were used to evaluate the impact of the intervention on outcomes. RESULTS: Overall adherence of Bio-K+ administration ranged from 76.9% to 84.6% when stratified by facility and periods. Rates of adherence to administration within 48 and 72 hours of antibiotic treatment were 60.2% -71.4% and 66.7%-75.8%, respectively. In the adjusted analysis, there was no change in HA-CDI (incidence rate ratio [IRR], 0.92; 95% confidence interval [CI], 0.68-1.23) or C. difficile positivity rate (IRR, 1.05; 95% CI, 0.89-1.24). Discharged patients may not have received a complete course of Bio-K+. Our hospitals had a low baseline incidence of HA-CDI. Patients who did not receive Bio-K+ may have differential risks of acquiring CDI, introducing selection bias. CONCLUSIONS: Hospitals considering probiotics as a primary prevention strategy should consider the baseline incidence of HA-CDI in their population and timing of probiotics relative to the start of antimicrobial administration.

Managing 'sick days' in patients with chronic conditions: An exploration of patient and healthcare provider experiences.

INTRODUCTION: People with chronic medical conditions often take medications that improve long-term outcomes but which can be harmful during acute illness. Guidelines recommend that healthcare providers offer instructions to temporarily stop these medications when patients are sick (i.e., sick days). We describe the experiences of patients managing sick days and of healthcare providers providing sick day guidance to their patients. METHODS: We undertook a qualitative descriptive study. We purposively sampled patients and healthcare providers from across Canada. Adult patients were eligible if they took at least two medications for diabetes, heart disease, high blood pressure and/or kidney disease. Healthcare providers were eligible if they were practising in a community setting with at least 1 year of experience. Data were collected using virtual focus groups and individual phone interviews conducted in English. Team members analyzed transcripts using conventional content analysis. RESULTS: We interviewed 48 participants (20 patients and 28 healthcare providers). Most patients were between 50 and 64 years of age and identified their health status as 'good'. Most healthcare providers were between 45 and 54 years of age and the majority practised as pharmacists in urban areas. We identified three overarching themes that summarize the experiences of patients and healthcare providers, largely suggesting a broad spectrum in approaches to managing sick days: Individualized Communication, Tailored Sick Day Practices, and Variation in Knowledge of Sick Day Practices and Relevant Resources. CONCLUSION: It is important to understand the perspectives of both patients and healthcare providers with respect to the management of sick days. This understanding can be used to improve care and outcomes for people living with chronic conditions during sick days. PATIENT OR PUBLIC CONTRIBUTION: Two patient partners were involved from proposal development to the dissemination of our findings, including manuscript development. Both patient partners took part in team meetings and contributed to team decision-making. Patient partners also participated in data analysis by reviewing codes and theme development. Furthermore, patients living with various chronic conditions and healthcare providers participated in focus groups and individual interviews.