Feasibility and acceptability of patient- and clinician-level antithrombotic stewardship interventions to reduce gastrointestinal bleeding risk in patients using warfarin (Anticoagulation with Enhanced Gastrointestinal Safety): a factorial randomized controlled pilot trial.

Background: Overuse of antiplatelet therapy and underuse of gastroprotection contribute to preventable bleeding in patients taking anticoagulants. Objectives: (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection and (2) assess intervention acceptability. Methods: Pragmatic 2 × 2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs usual care and (2) clinician notification vs clinician notification plus nurse facilitation was performed. The primary feasibility outcome was percentage of patients completing a structured telephone assessment after 5 weeks. Exploratory outcomes, including effectiveness, were evaluated using chart review, surveys, and semistructured interviews. Results: Among 47 eligible patients, 35/47 (74.5%; 95% CI, 58.6%-85.7%) met the feasibility outcome. In the subset confirmed to be high risk for upper GI bleeding, 11/29 (37.9%; 95% CI, 16.9%-64.7%) made a medication change, without differences between intervention arms. In interviews, few patients reported reviewing the activation booklet; barriers included underestimating GI bleeding risk, misunderstanding the booklet's purpose, and receiving excessive health communication materials. Clinicians responded to notification messages for 24/47 patients (51.1%; 95% CI, 26.4%-75.4%), which was lower for surgeons than nonsurgeons (22.7% vs 76.0%). Medical specialists but not surgeons viewed clinician notification as acceptable. Conclusion: The proposed trial design and outcome ascertainment strategy were feasible, but the patient activation intervention is unlikely to be effective as designed. While clinician notification appears promising, it may not be acceptable to surgeons, findings which support further refinement and testing of a clinician notification intervention.

Development of a multicomponent implementation strategy to reduce upper gastrointestinal bleeding risk in patients using warfarin and antiplatelet therapy, and protocol for a pragmatic multilevel randomized factorial pilot implementation trial.

BACKGROUND: The concomitant use of anticoagulant and antiplatelet medications increases the risk of upper gastrointestinal (GI) bleeding. Two underused evidence-based practices (EBPs) can reduce the risk: de-prescribe unnecessary antiplatelet therapy or initiate a proton pump inhibitor. We describe the development of a multicomponent intervention to increase use of these EBPs in patients treated with warfarin and followed by an anticoagulation monitoring service (AMS), and the design of a pilot pragmatic implementation trial. METHODS: A participatory planning group iteratively used Implementation Mapping and the Multiphase Optimization Strategy to develop implementation strategies and plan the trial. Informed by qualitative interviews with patients and clinicians, we drew on several implementation science theories, as well as self-determination theory, to design interventions. For patients, we developed an activation guide to help patients discuss the EBPs with their clinicians. For clinicians, we developed two electronic health record (EHR)-based interventions: (1) clinician notification (CN) consists of a templated message that identifies a patient as high risk, summarizes the EBPs, and links to a guidance statement on appropriate use of antiplatelet therapy. (2) Clinician notification with nurse facilitation (CN+NF) consists of a similar notification message but includes additional measures by nursing staff to support appropriate and timely decision-making: the nurse performs a chart review to identify any history of vascular disease, embeds indication-specific guidance on antiplatelet therapy in the message, and offers to assist with medication order entry and patient education. We will conduct a pilot factorial cluster- and individual-level randomized controlled trial with a primary objective of evaluating feasibility. Twelve clinicians will be randomized to receive either CN or CN+NF for all their patients managed by the AMS while 50 patients will be individually randomized to receive either the activation guide or usual care. We will explore implementation outcomes using patient and clinician interviews along with EHR review. DISCUSSION: This pilot study will prepare us to conduct a larger optimization study to identify the most potent and resource conscious multicomponent implementation strategy to help AMSs increase the use of best practices for upper GI bleeding risk reduction. TRIAL REGISTRATION: ClinicalTrials.gov NCT05085405 . Registered on October 19, 2021-retrospectively registered.

Root Cause Analysis of Adverse Events in an Outpatient Anticoagulation Management Consortium.

BACKGROUND: A number of factors can lead to adverse events (AEs) in patients taking warfarin. Performing a root cause analysis (RCA) of serious AEs is one systematic way of determining the causes of these events. METHODS: Multidisciplinary teams were formed at Michigan Anticoagulation Quality Improvement Initiative (MAQI2) sites with organized anticoagulation management services (AMS). Medical records from patients who suffered serious AEs (major bleed, embolic stroke, venous thromboembolism) were reviewed, and AMS staff were interviewed to determine the root cause using the "5 Whys" technique. More than 600 patients had an AE and underwent screening by trained RNs. Of these, 79 required full review by a multidisciplinary panel. All potential contributing factors (comorbidities, concurrent medications, current protocols) were assessed to determine the main factor that caused the AE. RESULTS: Full RCA was completed in 79 cases. The main contributing factor was identified in 69/79 (87%) cases. Most identified AEs, 55/69 (80%), were due to patient-specific factors such as comorbidities. Patient-to-provider and provider-to-provider communication accounted for 16/69 (23%) of events and was the second most common cause. Other causes included protocol non-adherence and technology/equipment issues. After each detailed review, the multidisciplinary panel recommended system changes that addressed the primary cause. CONCLUSION: The majority of severe AEs for patients taking warfarin were related to nonmodifiable patient-related issues. The remaining AEs were primarily due to patient-to-provider and provider-to-provider communication issues. Methods for improving communication need to be addressed, and methods for more effective patient education should be investigated.