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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.
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OBJECTIVE: To determine how a large scale, multicomponent, pharmacy based intervention to reduce proton pump inhibitor (PPI) overuse affected prescribing patterns, healthcare utilization, and clinical outcomes. DESIGN: Difference-in-difference study. SETTING: US Veterans Affairs Healthcare System, in which one regional network implemented the overuse intervention and all 17 others served as controls. PARTICIPANTS: All individuals receiving primary care from 2009 to 2019. INTERVENTION: Limits on PPI refills for patients without a documented indication for long term use, voiding of PPI prescriptions not recently filled, facilitated electronic prescribing of H2 receptor antagonists, and education for patients and clinicians. MAIN OUTCOME MEASURES: The primary outcome was the percentage of patients who filled a PPI prescription per 6 months. Secondary outcomes included percentage of days PPI gastroprotection was prescribed in patients at high risk for upper gastrointestinal bleeding, percentage of patients who filled either a PPI or H2 receptor antagonist prescription, hospital admission for acid peptic disease in older adults appropriate for PPI gastroprotection, primary care visits for an upper gastrointestinal diagnosis, upper endoscopies, and PPI associated clinical conditions. RESULTS: The number of patients analyzed per interval ranged from 192 607 to 250 349 in intervention sites and from 3 775 953 to 4 360 868 in control sites, with 26% of patients receiving PPIs before the intervention. The intervention was associated with an absolute reduction of 7.3% (95% confidence interval -7.6% to -7.0%) in patients who filled PPI prescriptions, an absolute reduction of 11.3% (-12.0% to -10.5%) in PPI use among patients appropriate for gastroprotection, and an absolute reduction of 5.72% (-6.08% to -5.36%) in patients who filled a PPI or H2 receptor antagonist prescription. No increases were seen in primary care visits for upper gastrointestinal diagnoses, upper endoscopies, or hospital admissions for acid peptic disease in older patients appropriate for gastroprotection. No clinically significant changes were seen in any PPI associated clinical conditions. CONCLUSIONS: The multicomponent intervention was associated with reduced PPI use overall but also in patients appropriate for gastroprotection, with minimal evidence of either clinical benefits or harms.
Subject(s)
Delivery of Health Care, Integrated , Gastrointestinal Diseases , Humans , Aged , Proton Pump Inhibitors/therapeutic use , Histamine H2 Antagonists/therapeutic use , Gastrointestinal Hemorrhage/chemically inducedABSTRACT
Balancing the safety and efficacy of antithrombotic agents in patients with gastrointestinal disorders is challenging because of the potential for interference with the absorption of antithrombotic drugs and for an increased risk of bleeding. In this Review, we address considerations for enteral antithrombotic therapy in patients with cardiovascular disease and gastrointestinal comorbidities. For those with gastrointestinal bleeding (GIB), we summarize a general scheme for risk stratification and clinical evidence on risk reduction approaches, such as limiting the use of concomitant medications that increase the risk of GIB and the potential utility of gastrointestinal protection strategies (such as proton pump inhibitors or histamine type 2 receptor antagonists). Furthermore, we summarize the best available evidence and potential gaps in our knowledge on tailoring antithrombotic therapy in patients with active or recent GIB and in those at high risk of GIB but without active or recent GIB. Finally, we review the recommendations provided by major medical societies, highlighting the crucial role of teamwork and multidisciplinary discussions to customize the antithrombotic regimen in patients with coexisting cardiovascular and gastrointestinal diseases.
Subject(s)
Cardiovascular Diseases , Fibrinolytic Agents , Gastrointestinal Diseases , Gastrointestinal Hemorrhage , Humans , Fibrinolytic Agents/therapeutic use , Fibrinolytic Agents/adverse effects , Cardiovascular Diseases/prevention & control , Gastrointestinal Diseases/chemically induced , Gastrointestinal Diseases/drug therapy , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/prevention & control , Risk Assessment , Risk Factors , ComorbidityABSTRACT
Antisecretory medications, primarily proton pump inhibitors (PPIs), have proven effective in reducing upper gastrointestinal toxicities, including upper gastrointestinal bleeding (UGIB), associated with nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin, which are among the most commonly used medications in the United States.1 Accordingly, professional guidance recommends PPIs for patients at high risk for UGIB.2-4 However, little is known about trends in use of antisecretory medications for gastrointestinal prophylaxis ("gastroprotection"). Herein, we examined contemporary use and prescribing of antisecretory medications in visits by patients at high risk for UGIB, relative to visits by patients diagnosed with acid-related disorders.
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INTRODUCTION: Guidelines suggest 1-time screening with esophagogastroduodenoscopy (EGD) for Barrett's esophagus (BE) in individuals at an increased risk of esophageal adenocarcinoma (EAC). We aimed to estimate the yield of repeat EGD performed at prolonged intervals after a normal index EGD. METHODS: We conducted a national retrospective analysis within the U S Veterans Health Administration, identifying patients with a normal index EGD between 2003 and 2009 who subsequently had a repeat EGD. We tabulated the proportion with a new diagnosis of BE, EAC, or esophagogastric junction adenocarcinoma (EGJAC) and conducted manual chart review of a sample. We fitted logistic regression models for the odds of a new diagnosis of BE/EAC/EGJAC. RESULTS: We identified 71,216 individuals who had a repeat EGD between 1 and 16 years after an index EGD without billing or cancer registry codes for BE/EAC/EGJAC. Of them, 4,088 had a new billing or cancer registry code for BE/EAC/EGJAC after the repeat EGD. On manual review of a stratified sample, most did not truly have new BE/EAC/EGJAC. A longer duration between EGD was associated with greater odds of a new diagnosis (adjusted odds ratio [aOR] for each 5 years 1.31; 95% confidence interval [CI] 1.19-1.44), particularly among those who were younger during the index EGD (ages 19-29 years: aOR 3.92; 95% CI 1.24-12.4; ages 60-69 years: aOR 1.19; 95% CI 1.01-1.40). DISCUSSION: The yield of repeat EGD for BE/EAC/EGJAC seems to increase with time after a normal index EGD, particularly for younger individuals. Prospective studies are warranted to confirm these findings.
Subject(s)
Adenocarcinoma , Barrett Esophagus , Esophageal Neoplasms , Humans , Barrett Esophagus/diagnosis , Barrett Esophagus/pathology , Retrospective Studies , Esophageal Neoplasms/diagnosis , Esophageal Neoplasms/epidemiology , Esophageal Neoplasms/etiology , Adenocarcinoma/diagnosis , Adenocarcinoma/epidemiology , Adenocarcinoma/complications , Endoscopy, Gastrointestinal/adverse effectsABSTRACT
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.
Subject(s)
Histamine H2 Antagonists , Proton Pump Inhibitors , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Anticoagulants/adverse effects , Aspirin/therapeutic use , Gastrointestinal Agents/therapeutic use , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/prevention & control , Histamine H2 Antagonists/adverse effects , Humans , Observational Studies as Topic , Proton Pump Inhibitors/adverse effectsABSTRACT
Recent trials suggest that aspirin for primary prevention may do more harm than good for some, including adults over 70 years of age. We sought to assess how primary care providers (PCPs) use aspirin for the primary prevention in older patients and to identify barriers to use according to recent guidelines, which recommend against routine use in patients over age 70. We surveyed PCPs about whether they would recommend aspirin in clinical vignettes of a 75-year-old patient with a 10-year atherosclerotic cardiovascular disease risk of 25%. We also queried perceived difficulty following guideline recommendations, as well as perceived barriers and facilitators. We obtained responses from 372 PCPs (47.9% response). In the patient vignette, 45.4% of clinicians recommended aspirin use, which did not vary by whether the patient was using aspirin initially (p = 0.21); 41.7% believed aspirin was beneficial. Perceived barriers to guideline-based aspirin use included concern about patients being upset (41.6%), possible malpractice claims (25.0%), and not having a strategy for discussing aspirin use (24.5%). The estimated adjusted probability of rating the guideline as "hard to follow" was higher in clinicians who believed aspirin was beneficial (29.4% vs. 8.0%; p < 0.001) and who worried the patient would be upset if told to stop aspirin (26.7% vs. 12.5%; p = 0.001). Internists vary considerably in their recommendations for aspirin use for primary prevention in older patients. A high proportion of PCPs continue to believe aspirin is beneficial in this setting. These results can inform de-implementation efforts to optimize evidence-based aspirin use.
Subject(s)
Aspirin , Physicians , Humans , Aged , Aged, 80 and over , Aspirin/therapeutic use , Attitude of Health Personnel , Surveys and QuestionnairesABSTRACT
BACKGROUND: The adoption and sustainment of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of three EBPs: (1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; (2) appropriate dosing and drug selection of direct oral anticoagulants (DOACs); and (3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies. METHODS: For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to relevant clinical data to identify patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve the use of the EBPs: (1) individual-level academic detailing (AD) or (2) AD plus the team-based Learn. Engage. Act. PROCESS: (LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly (13 to 36 months) percent of PIMs as the dependent variable. Primary comparative endpoint will be at 18 months post-baseline. Each trial will also be analyzed independently. DISCUSSION: MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates the use of actional clinical data and making incremental changes, designed to be feasible within busy clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05065502 . Registered October 4, 2021-retrospectively registered.
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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.
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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.
Subject(s)
Gastrointestinal Hemorrhage , Proton Pump Inhibitors , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/drug therapy , Gastrointestinal Hemorrhage/prevention & control , Humans , Proton Pump Inhibitors/therapeutic useABSTRACT
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.
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BACKGROUND: Inadequate bowel preparation undermines the quality of colonoscopy, but patients likely to be affected are difficult to identify beforehand. AIMS: This study aimed to develop, validate, and compare prediction models for bowel preparation inadequacy using conventional logistic regression (LR) and random forest machine learning (RFML). METHODS: We created a retrospective cohort of patients who underwent outpatient colonoscopy at a single VA medical center between January 2012 and October 2015. Candidate predictor variables were chosen after a literature review. We extracted all available predictor variables from the electronic medical record, and bowel preparation from the endoscopy database. The data were split into 70% training and 30% validation sets. Multivariable LR and RFML were used to predict preparation inadequacy as a dichotomous outcome. RESULTS: The cohort included 6,885 Veterans, of whom 964 (14%) had inadequate preparation. Using LR, the area under the receiver operating characteristic curve (AUC) for the validation cohort was 0.66 (95% CI 0.62, 0.69) and the Brier score, in which a lower score indicates better performance, was 0.11. Using RFML, the AUC for the validation cohort was 0.61 (95% CI 0.58, 0.65) and the Brier score was 0.12. CONCLUSIONS: LR and RFML had similar performance in predicting bowel preparation, which was modest and likely insufficient for use in practice. Future research is needed to identify additional predictor variables and to test other machine learning algorithms. At present, endoscopy units should focus on universal strategies to enhance preparation adequacy.
Subject(s)
Veterans , Humans , Logistic Models , Machine Learning , Retrospective Studies , Risk AssessmentABSTRACT
OBJECTIVES: To describe associations between patient factors and interest in and concerns about telehealth video visits among adults in midlife and older. STUDY DESIGN: A cross-sectional, nationally representative panel survey of US adults aged 50 to 80 years (N = 2256) in May 2019. METHODS: Multivariable logistic regression was used to estimate the adjusted prevalence of interest in different types of video telehealth visits and concerns about telehealth for individuals with different characteristics. RESULTS: Individuals aged 65 to 80 (vs 50-64) years were more likely to be interested in a first-time telehealth visit (37.3% vs 31.5%; P < .05) and to be concerned about not feeling personally connected to their provider (52.8% vs 46.5%; P < .05). Women (vs men) were less likely to be interested in a first-time visit (29.3% vs 38.2%; P < .001) and more likely to be concerned about technical difficulties (52.3% vs 42.1%; P < .001). Black, non-Hispanic individuals (vs White, non-Hispanic individuals) were more likely to be interested in first-time (45.2% vs 29.8%; P < .001) and return (67.7% vs 56.2%; P < .01) visits. Individuals comfortable using video chat (vs never users) were more likely to be interested in a telehealth visit for any reason (all P < .001) and less likely to have concerns about privacy, difficulty seeing/hearing, technical difficulties, not feeling personally connected, and lower quality of care (all P < .01). CONCLUSIONS: Interest in and concerns about telehealth vary along the lines of sociodemographic factors and experience using the internet for video communication. These findings have implications for the design of interventions and policies to promote equitable access to health care as it increasingly moves online.
Subject(s)
Telemedicine , Adult , Communication , Cross-Sectional Studies , Female , Humans , Male , PrevalenceABSTRACT
Potent antithrombotic agents are routinely prescribed after percutaneous coronary intervention (PCI) to reduce ischemic complications. However, in patients who are at an increased bleeding risk, this may pose significant risks. We sought to evaluate the association between a history of gastrointestinal bleeding (GIB) and outcomes after PCI. We linked clinical registry data from PCIs performed at 48 Michigan hospitals between 1/2013 and 3/2018 to Medicare claims. We used 1:5 propensity score matching to adjust for patient characteristics. In-hospital outcomes included bleeding, transfusion, stroke or death. Post-discharge outcomes included 90-day all-cause readmission and long-term mortality. Of 30,206 patients, 1.1% had a history of GIB. Patients with a history of GIB were more likely to be older, female, and have more cardiovascular comorbidities. After matching, those with a history of GIB (n = 312) had increased post-procedural transfusions (15.7% vs 8.4%; p < 0.001), bleeding (11.9% vs 5.2%; p < 0.001), and major bleeding (2.8% vs 0.6%; p = 0.004). Ninety-day readmission rates were similar among those with and without a history of GIB (34.3% vs 31.3%; p = 0.318). There was no significant difference in post-discharge survival (1 year: 78% vs 80%; p = 0.217; 5 years: 54% vs 51%; p = 0.189). In conclusion, after adjusting for baseline characteristics, patients with a history of GIB had increased risk of post-PCI in-hospital bleeding complications. However, a history of GIB was not significantly associated with 90-day readmission or long-term survival.
Subject(s)
Blue Cross Blue Shield Insurance Plans/statistics & numerical data , Coronary Artery Disease/surgery , Gastrointestinal Hemorrhage/complications , Percutaneous Coronary Intervention/methods , Registries , Aged , Coronary Artery Disease/complications , Coronary Artery Disease/epidemiology , Female , Follow-Up Studies , Humans , Incidence , Male , Michigan/epidemiology , Patient Discharge/trends , Propensity Score , Retrospective Studies , Risk Factors , Survival Rate/trendsABSTRACT
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.
Subject(s)
Clinical Trials as Topic , Dual Anti-Platelet Therapy/standards , Percutaneous Coronary Intervention/methods , Platelet Aggregation Inhibitors/therapeutic use , Postoperative Care/methods , Practice Guidelines as Topic , Stomach Diseases/prevention & control , Humans , Platelet Aggregation Inhibitors/adverse effects , Stomach/drug effectsABSTRACT
BACKGROUND & AIMS: Many patients with symptoms of gastroesophageal reflux disease (GERD) not responding to a proton pump inhibitor (PPI) undergo an upper endoscopy. We hypothesized that an incomplete response to a PPI is not associated with findings of esophageal pathology on endoscopy, and that psychological distress is associated inversely with pathology. METHODS: We enrolled consecutive individuals aged 40 to 79 years with prior heartburn or regurgitation. Logistic regression was used to estimate the effects of incomplete response of GERD symptoms and psychological distress on the odds of finding erosive esophagitis or Barrett's esophagus. RESULTS: A total of 625 patients completed the study. A total of 254 (66.8% of those taking PPI) had GERD symptoms incompletely responsive to a PPI and 352 (56.3%) had severe somatization. An incomplete response to a PPI was associated with psychological distress (P < .001). Erosive esophagitis was found in 148 subjects (23.7%) and Barrett's esophagus in 58 (9.3%). Overall, an incomplete response to a PPI was not found to be associated with these pathologies (odds ratio, 1.17; 95% CI, 0.720-1.91). In contrast, greater psychological distress was associated inversely with erosive esophagitis or Barrett's esophagus (in particular, highest vs lowest tertile somatization: odds ratio, 0.590; 95% CI, 0.365-0.952). CONCLUSIONS: Patients undergoing upper endoscopy frequently have GERD symptoms incompletely responding to a PPI and a high burden of somatization. However, an incomplete response of GERD symptoms is a poor predictor for endoscopic pathology, and should not be relied upon for selecting patients for screening for Barrett's esophagus. Patients with high psychological distress are less likely to have esophageal pathology.
Subject(s)
Barrett Esophagus , Esophagitis , Gastroesophageal Reflux , Barrett Esophagus/complications , Barrett Esophagus/epidemiology , Esophagitis/diagnosis , Esophagitis/epidemiology , Gastroesophageal Reflux/complications , Gastroesophageal Reflux/epidemiology , Heartburn , Humans , Proton Pump Inhibitors/therapeutic useABSTRACT
BACKGROUND: Implementation of evidence-based practices often requires tailoring implementation strategies to local contextual factors, including available resources, expertise, and cultural norms. Using an exemplar case, we describe how health systems engineering methods can be used to understand system-level variation that must be accounted for prior to broad implementation. METHODS: Within the context of a single-center quality improvement activity, a multi-disciplinary stakeholder team used health systems engineering methods to describe how pre-endoscopy antithrombotic management was executed, and implemented a redesigned process to improve clinical care. The research team then conducted multiple stakeholder focus groups at four different health-care systems to describe and compare current processes for pre-endoscopy antithrombotic medication management. Detailed work flow maps for each health-care system were developed, analyzed, and integrated to develop an overarching current work flow map, identify key process steps, and describe areas of process variation. RESULTS: Five key process steps were identified across the four health systems: (1) place an endoscopy order, (2) screen for antithrombotic use, (3) coordinate medication management, (4) instruct the patient, and (5) confirm appropriate medication management before procedure. Across health systems, we found a high degree of variation in each step (e.g., who performed, use of technology, systematic vs. ad hoc process). This variation was influenced by two key system-level contextual factors: (1) degree of health system integration and (2) role and training level of available staff. These key steps, areas of variation, and contextual factors were integrated into an assessment tool designed to facilitate tailoring of a future implementation and dissemination strategy. CONCLUSIONS: Tools from health systems engineering can be used to identify key work flow process steps, variations in how those steps are executed, and influential contextual factors. This process and the associated assessment tool may facilitate broader implementation tailoring.
Subject(s)
Delivery of Health Care , Quality Improvement , Government Programs , HumansABSTRACT
BACKGROUND: An effective patient-physician relationship (PPR) is essential to the care of patients with irritable bowel syndrome (IBS). After developing a PPR questionnaire for patients, we sought to develop and validate an IBS-specific instrument to measure physician expectations of the PPR. METHODS: We conducted focus groups about PPRs among 15 clinicians who treat patients with IBS from community and academic centers. Qualitative analysis was used to generate the Patient-Physician Relationship Scale -Physician RESULTS: The PPRS-Physician contained 35 questions pertaining to interpersonal and psychosocial features considered desirable or undesirable in a relationship with IBS patients. 1113 physicians (22%) completed the survey. Physicians were predominantly middle-aged (mean = 55.1 years), male (85.0%), white (74.5%), and practiced primarily within group settings (61.6%), with an average of 25.7% of their patients having IBS. Factor analysis revealed three relevant factors: interfering attributes, positive attributes, and personal connection. The scale ranged from possible 0 to 100 (mean = 83.8; SD = 8.38). Cronbach's alpha reliability measure of the scale was 0.938, indicating high internal consistency. There was a significant moderate, positive correlation between JSPE and the PPRS (P < 0.001, r = 0.488), establishing concurrent validity. CONCLUSIONS: We describe the development and validation of the first questionnaire to measure physician expectations of the PPR. This instrument can be used clinically, and for future studies on physician communication.