Consensus Recommendations for Sick Day Medication Guidance for People With Diabetes, Kidney, or Cardiovascular Disease: A Modified Delphi Process.

RATIONALE & OBJECTIVE: Sick day medication guidance (SDMG) involves withholding or adjusting specific medications in the setting of acute illnesses that could contribute to complications such as hypotension, acute kidney injury (AKI), or hypoglycemia. We sought to achieve consensus among clinical experts on recommendations for SDMG that could be studied in future intervention studies. STUDY DESIGN: A modified Delphi process following guidelines for conducting and reporting Delphi studies. SETTING & PARTICIPANTS: An international group of clinicians with expertise relevant to SDMG was recruited through purposive and snowball sampling. A scoping review of the literature was presented, followed by 3 sequential rounds of development, refinement, and voting on recommendations. Meetings were held virtually and structured to allow the participants to provide their input and rapidly prioritize and refine ideas. OUTCOME: Opinions of participants were measured as the percentage who agreed with each recommendation, whereas consensus was defined as >75% agreement. ANALYTICAL APPROACH: Quantitative data were summarized using counts and percentages. A qualitative content analysis was performed to capture the context of the discussion around recommendations and any additional considerations brought forward by participants. RESULTS: The final panel included 26 clinician participants from 4 countries and 10 clinical disciplines. Participants reached a consensus on 42 specific recommendations: 5 regarding the signs and symptoms accompanying volume depletion that should trigger SDMG; 6 regarding signs that should prompt urgent contact with a health care provider (including a reduced level of consciousness, severe vomiting, low blood pressure, presence of ketones, tachycardia, and fever); and 14 related to scenarios and strategies for patient self-management (including frequent glucose monitoring, checking ketones, fluid intake, and consumption of food to prevent hypoglycemia). There was consensus that renin-angiotensin system inhibitors, diuretics, nonsteroidal anti-inflammatory drugs, sodium/glucose cotransporter 2 inhibitors, and metformin should be temporarily stopped. Participants recommended that insulin, sulfonylureas, and meglitinides be held only if blood glucose was low and that basal and bolus insulin be increased by 10%-20% if blood glucose was elevated. There was consensus on 6 recommendations related to the resumption of medications within 24-48 hours of the resolution of symptoms and the presence of normal patterns of eating and drinking. LIMITATIONS: Participants were from high-income countries, predominantly Canada. Findings may not be generalizable to implementation in other settings. CONCLUSIONS: A multidisciplinary panel of clinicians reached a consensus on recommendations for SDMG in the presence of signs and symptoms of volume depletion, as well as self-management strategies and medication instructions in this setting. These recommendations may inform the design of future trials of SDMG strategies.

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.

Implementation strategies for hospital-based probiotic administration in a stepped-wedge cluster randomized trial design for preventing hospital-acquired Clostridioides difficile infection.

BACKGROUND: Clostridioides difficile infection (CDI) is associated with considerable morbidity and mortality in hospitalized patients, especially among older adults. Probiotics have been evaluated to prevent hospital-acquired (HA) CDI in patients who are receiving systemic antibiotics, but the implementation of timely probiotic administration remains a challenge. We evaluated methods for effective probiotic implementation across a large health region as part of a study to assess the real-world effectiveness of a probiotic to prevent HA-CDI (Prevent CDI-55 +). METHODS: We used a stepped-wedge cluster-randomized controlled trial across four acute-care adult hospitals (n = 2,490 beds) to implement the use of the probiotic Bio-K + ® (Lactobacillus acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®; Laval, Quebec, Canada) in patients 55 years and older receiving systemic antimicrobials. The multifaceted probiotic implementation strategy included electronic clinical decision support, local site champions, and both health care provider and patient educational interventions. Focus groups were conducted during study implementation to identify ongoing barriers and facilitators to probiotic implementation, guiding needed adaptations of the implementation strategy. Focus groups were thematically analyzed using the Theoretical Domains Framework and the Consolidated Framework of Implementation Research. RESULTS: A total of 340 education sessions with over 1,800 key partners and participants occurred before and during implementation in each of the four hospitals. Site champions were identified for each included hospital, and both electronic clinical decision support and printed educational resources were available to health care providers and patients. A total of 15 individuals participated in 2 focus group and 7 interviews. Key barriers identified from the focus groups resulted in adaptation of the electronic clinical decision support and the addition of nursing education related to probiotic administration. As a result of modifying implementation strategies for identified behaviour change barriers, probiotic adherence rates were from 66.7 to 75.8% at 72 h of starting antibiotic therapy across the four participating acute care hospitals. CONCLUSIONS: Use of a barrier-targeted multifaceted approach, including electronic clinical decision support, education, focus groups to guide the adaptation of the implementation plan, and local site champions, resulted in a high probiotic adherence rate in the Prevent CDI-55 + study.

Managing Medications During "Sick Days" in Patients With Diabetes, Kidney, and Cardiovascular Conditions: A Theory-informed Approach to Intervention Design and Implementation.

OBJECTIVES: Our aim in this work was to 1) explore barriers and enablers to patient and health-care provider (HCP) behaviours related to sick-day medication guidance (SDMG), 2) identify theory-informed strategies to advise SDMG intervention design, and 3) obtain perspectives on an eHealth tool for this purpose. METHODS: A qualitative descriptive study using qualitative conventional content analysis was undertaken. Interviews and focus groups were held with patients and HCPs from January 2021 to April 2022. Data were analyzed using the Behaviour Change Wheel and Theoretical Domains Framework to inform intervention design. RESULTS: Forty-eight people (20 patients, 13 pharmacists, 12 family physicians, and 3 nurse practitioners) participated in this study. Three interventions were designed to address the identified barriers and enablers: 1) prescriptions provided by a community-based care provider, 2) pharmacists adding a label to at-risk medications, and 3) built-in prompts for prescribing and dispensing software. Most participants accepted the concept of an eHealth tool and identified pharmacists as the ideal point-of-care provider. Challenges for an eHealth tool were raised, including credibility, privacy of data, medical liability, clinician remuneration and workload impact, and equitable access to use of the tool. CONCLUSIONS: Patients and HCPs endorsed non-technology and eHealth innovations as strategies to aid in the delivery of SDMG. These findings can guide the design of future theory-informed SDMG interventions.

Deployment of a human-centred clinical decision support system for pulmonary embolism: evaluation of impact on quality of diagnostic decisions.

Pulmonary embolism (PE) is a serious condition that presents a diagnostic challenge for which diagnostic errors often happen. The literature suggests that a gap remains between PE diagnostic guidelines and adherence in healthcare practice. While system-level decision support tools exist, the clinical impact of a human-centred design (HCD) approach of PE diagnostic tool design is unknown. DESIGN: Before-after (with a preintervention period as non-concurrent control) design study. SETTING: Inpatient units at two tertiary care hospitals. PARTICIPANTS: General internal medicine physicians and their patients who underwent PE workups. INTERVENTION: After a 6-month preintervention period, a clinical decision support system (CDSS) for diagnosis of PE was deployed and evaluated over 6 months. A CDSS technical testing phase separated the two time periods. MEASUREMENTS: PE workups were identified in both the preintervention and CDSS intervention phases, and data were collected from medical charts. Physician reviewers assessed workup summaries (blinded to the study period) to determine adherence to evidence-based recommendations. Adherence to recommendations was quantified with a score ranging from 0 to 1.0 (the primary study outcome). Diagnostic tests ordered for PE workups were the secondary outcomes of interest. RESULTS: Overall adherence to diagnostic pathways was 0.63 in the CDSS intervention phase versus 0.60 in the preintervention phase (p=0.18), with fewer workups in the CDSS intervention phase having very low adherence scores. Further, adherence was significantly higher when PE workups included the Wells prediction rule (median adherence score=0.76 vs 0.59, p=0.002). This difference was even more pronounced when the analysis was limited to the CDSS intervention phase only (median adherence score=0.80 when Wells was used vs 0.60 when Wells was not used, p=0.001). For secondary outcomes, using both the D-dimer blood test (42.9% vs 55.7%, p=0.014) and CT pulmonary angiogram imaging (61.9% vs 75.4%, p=0.005) was lower during the CDSS intervention phase. CONCLUSION: A clinical decision support intervention with an HCD improves some aspects of the diagnostic decision, such as the selection of diagnostic tests and the use of the Wells probabilistic prediction rule for PE.

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.

Sick Day Medication Guidance for People With Diabetes, Kidney Disease, or Cardiovascular Disease: A Systematic Scoping Review.

Rationale & Objective: Sick day medication guidance has been promoted to prevent adverse events for people with chronic conditions. Our aim was to summarize the existing sick day medication guidance and the evidence base for the effectiveness of interventions for implementing this guidance. Study Design: Scoping review of quantitative and qualitative studies. Setting & Population: Sick day medication guidance for people with chronic conditions including diabetes mellitus, kidney diseases, and cardiovascular diseases. Selection Criteria for Studies: A search of 6 bibliographic databases (Ovid MEDLINE, Ovid Embase, CINAHL, Scopus, Web of Science Core Collection, and Cochrane Library [via Wiley]) and a comprehensive gray literature search were completed in June 2021. Data Extraction: Intervention and study characteristics were extracted using standardized tools. Analytical Approach: Data were summarized descriptively, and our approach observed the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews. Results: The literature search identified 2,308 documents, which were screened against the eligibility criteria, leading to 74 documents that were included. The majority of the identified documents (n = 55) were guidelines or educational resources. Of the 19 primary research studies identified, 10 studies described an intervention, with only 2 examining the effect of sick day medication guidance interventions within clinical care and no studies reporting beneficial effects on clinical outcomes. Most documents (n = 58) included guidance specific to patients with diabetes mellitus, with fewer including guidance for patients with chronic kidney disease (n = 9) or heart failure (n = 2). Limitations: Risk of bias was not assessed. Conclusions: Many resources promoting sick day medication guidance have been developed; however, there is very little empirical evidence for the effectiveness of current approaches in implementing sick day medication guidance into practice. Recommendations for the use of sick day medication guidance will require further research to develop consistent, understandable, and usable approaches for its implementation within self-management strategies as well as empirical studies to demonstrate the effectiveness of these interventions.