Barriers to Guideline-Based Use of Proton Pump Inhibitors to Prevent Upper Gastrointestinal Bleeding.

PURPOSE: Gastrointestinal (GI) bleeding is one of the most common serious adverse drug events. Guidelines recommend proton pump inhibitor (PPI) gastroprotection to prevent upper GI bleeding in high-risk patients, but this practice is underused. METHODS: To explore prescribing practices and barriers to the use of PPI gastroprotection, including dynamics within and across specialties, we conducted semistructured interviews with physicians in 4 specialties at a single institution. We performed thematic analysis of barriers, organized around the theoretical domains framework. RESULTS: The sample included 5 primary care physicians (PCPs), 4 cardiologists, 3 gastroenterologists, and 3 vascular surgeons. Most PCPs, gastroenterologists, and vascular surgeons seldom prescribed PPI gastroprotection. Cardiologists varied most in their use of PPI gastroprotection, with some prescribing it consistently and others never. Major barriers related to the following 3 themes: (1) knowledge, (2) decision processes, and (3) professional role. Knowledge of guidelines was greatest among cardiologists and gastroenterologists and low among PCPs and vascular surgeons, and PCPs tended to focus on adverse effects associated with PPIs, which made them reluctant to prescribe them. For cardiologists, prevention of bleeding was usually a priority, but they sometimes deferred prescribing to others. For the other 3 specialties, PPI gastroprotection was a low priority. There was unclear delineation of responsibility for prescribing gastroprotection between specialties. CONCLUSIONS: Major barriers to PPI gastroprotection relate to knowledge, decision processes, and professional role, which operate differentially across specialties. Multicomponent interventions will likely be necessary to improve guideline-based use of PPIs to prevent upper GI bleeding.VISUAL ABSTRACT.

Trials of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention Lack Strategies to Ensure Appropriate Gastroprotection.

INTRODUCTION: Gastrointestinal bleeding is a morbid complication of dual antiplatelet therapy (DAPT). We evaluated the extent to which contemporary trials of DAPT included steps to ensure appropriate use of proton pump inhibitor (PPI) gastroprotection and reported rates of PPI use. METHODS: A methodological review of randomized trials comparing varying durations of DAPT after percutaneous coronary intervention. RESULTS: Among 21 trials, none incorporated protocol procedures or guidance for prescribing PPIs. Five reported rates of PPI use (range 25.6-69.1%). DISCUSSION: PPI gastroprotection is overlooked in major trials of DAPT. Appropriate use of PPI gastroprotection represents an important opportunity to improve patient safety.

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.

Association of Antisecretory Drugs with Upper Gastrointestinal Bleeding in Patients Using Oral Anticoagulants: A Systematic Review and Meta-Analysis.

BACKGROUND: The role of antisecretory drugs for the prevention of upper gastrointestinal bleeding in patients using anticoagulants is unclear. We investigated this question in a systematic review and meta-analysis. METHODS: We searched Embase, PubMed, Web of Science, Scopus, the Cochrane Library, and clinicaltrials.gov thru April 2021 for controlled randomized trials and observational studies evaluating the association of proton pump inhibitors (PPIs) or H2-receptor antagonists with overt upper gastrointestinal bleeding in patients using anticoagulants. Independent duplicate review, data extraction, and risk of bias assessment were performed. Observational studies were included only if they provided results controlled for at least 2 variables. Meta-analyses were performed using random effects models. RESULTS: Six observational studies and 1 randomized trial were included. All but 1 study had low risk of bias. None of the studies excluded patients with concomitant aspirin or nonsteroidal anti-inflammatory drug use. For PPIs, the pooled relative risk of upper gastrointestinal bleeding was 0.67 (95% confidence interval 0.61, 0.74) with low statistical heterogeneity (I2 = 15%). Individual studies showed greater treatment effect in patients with higher risk for upper gastrointestinal bleeding (eg, nonsteroidal anti-inflammatory drug or aspirin use, elevated bleeding risk score). A single observational study evaluating the association of H2-receptor antagonists with upper gastrointestinal bleeding found a relative risk of 0.69 (95% confidence interval 0.24-2.02). CONCLUSIONS: Evidence drawn mostly from observational studies with low risk of bias demonstrate that PPIs reduce upper gastrointestinal bleeding in patients prescribed oral anticoagulants. The benefit appears to be most clearcut and substantial in patients with elevated risk of upper gastrointestinal bleeding.

Dashboards in Health Care Settings: Protocol for a Scoping Review.

BACKGROUND: Health care organizations increasingly depend on business intelligence tools, including "dashboards," to capture, analyze, and present data on performance metrics. Ideally, dashboards allow users to quickly visualize actionable data to inform and optimize clinical and organizational performance. In reality, dashboards are typically embedded in complex health care organizations with massive data streams and end users with distinct needs. Thus, designing effective dashboards is a challenging task and theoretical underpinnings of health care dashboards are poorly characterized; even the concept of the dashboard remains ill-defined. Researchers, informaticists, clinical managers, and health care administrators will benefit from a clearer understanding of how dashboards have been developed, implemented, and evaluated, and how the design, end user, and context influence their uptake and effectiveness. OBJECTIVE: This scoping review first aims to survey the vast published literature of "dashboards" to describe where, why, and for whom they are used in health care settings, as well as how they are developed, implemented, and evaluated. Further, we will examine how dashboard design and content is informed by intended purpose and end users. METHODS: In July 2020, we searched MEDLINE, Embase, Web of Science, and the Cochrane Library for peer-reviewed literature using a targeted strategy developed with a research librarian and retrieved 5188 results. Following deduplication, 3306 studies were screened in duplicate for title and abstract. Any abstracts mentioning a health care dashboard were retrieved in full text and are undergoing duplicate review for eligibility. Articles will be included for data extraction and analysis if they describe the development, implementation, or evaluation of a dashboard that was successfully used in routine workflow. Articles will be excluded if they were published before 2015, the full text is unavailable, they are in a non-English language, or they describe dashboards used for public health tracking, in settings where direct patient care is not provided, or in undergraduate medical education. Any discrepancies in eligibility determination will be adjudicated by a third reviewer. We chose to focus on articles published after 2015 and those that describe dashboards that were successfully used in routine practice to identify the most recent and relevant literature to support future dashboard development in the rapidly evolving field of health care informatics. RESULTS: All articles have undergone dual review for title and abstract, with a total of 2019 articles mentioning use of a health care dashboard retrieved in full text for further review. We are currently reviewing all full-text articles in duplicate. We aim to publish findings by mid-2022. Findings will be reported following guidance from the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. CONCLUSIONS: This scoping review will provide stakeholders with an overview of existing dashboard tools, highlighting the ways in which dashboards have been developed, implemented, and evaluated in different settings and for different end user groups, and identify potential research gaps. Findings will guide efforts to design and use dashboards in the health care sector more effectively. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34894.

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.

Opioid Policy and Chronic Pain Treatment Access Experiences: A Multi-Stakeholder Qualitative Analysis and Conceptual Model.

PURPOSE: Patients on long-term opioid therapy (LTOT) for pain have difficulty accessing primary care clinicians who are willing to prescribe opioids or provide multimodal pain treatment. Recent treatment guidelines and statewide policies aimed at reducing inappropriate prescribing may exacerbate these access issues, but further research is needed on this issue. This study aimed to understand barriers to primary care access and multimodal treatment for chronic pain from the perspective of multiple stakeholders. METHODS: Qualitative, semi-structured phone interviews were conducted with adult patients with chronic pain, primary care clinicians, and clinic office staff in Michigan. Interview questions covered stakeholder experiences with prescription opioids, opioid-related policies, and access to care for chronic pain. Interviews were coded using inductive and deductive methods for thematic analysis. RESULTS: A total of 25 interviews were conducted (15 patients, 7 primary care clinicians, and 3 office staff). Barriers to treatment access were attributed to six themes: (1) reduced clinic willingness to manage prescribed opioids for new patients; (2) lack of time and reimbursement for quality opioid-related care; (3) paucity of multimodal care and coordination between providers; (4) fear of liability and use of new guidelines to justify not prescribing opioids; (5) delayed prescription receipt due to prior authorization and pharmacy issues; and (6) poor availability of effective non-opioid treatments. CONCLUSION: Issues of policy, logistics, and clinic-level resources converge to disrupt treatment access for patients with chronic pain, as many clinics both do not offer multimodal pain care and are unwilling to prescribe LTOT. The resulting conceptual model can inform the development of policy interventions to help mitigate these access barriers.