Browsing by Subject "Clinical Protocols"

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    Adapting ethical guidelines for adolescent health research to street-connected children and youth in low- and middle-income countries: a case study from western Kenya
    (Springer (Biomed Central Ltd.), 2015-12-18) Embleton, L.; Ott, Mary A.; Wachira, J.; Naanyu, V.; Kamanda, A.; Makori, D.; Ayuku, D.; Braitstein, P.; Department of Epidemiology, Richard M. Fairbanks School of Public Health
    BACKGROUND: Street-connected children and youth (SCCY) in low- and middle-income countries (LMIC) have multiple vulnerabilities in relation to participation in research. These require additional considerations that are responsive to their needs and the social, cultural, and economic context, while upholding core ethical principles of respect for persons, beneficence, and justice. The objective of this paper is to describe processes and outcomes of adapting ethical guidelines for SCCY's specific vulnerabilities in LMIC. METHODS: As part of three interrelated research projects in western Kenya, we created procedures to address SCCY's vulnerabilities related to research participation within the local context. These consisted of identifying ethical considerations and solutions in relation to community engagement, equitable recruitment, informed consent, vulnerability to coercion, and responsibility to report. RESULTS: Substantial community engagement provided input on SCCY's participation in research, recruitment, and consent processes. We designed an assent process to support SCCY to make an informed decision regarding their participation in the research that respected their autonomy and their right to dissent, while safeguarding them in situations where their capacity to make an informed decision was diminished. To address issues related to coercion and access to care, we worked to reduce the unequal power dynamic through street outreach, and provided access to care regardless of research participation. CONCLUSIONS: Although a vulnerable population, the specific vulnerabilities of SCCY can to some extent be managed using innovative procedures. Engaging SCCY in ethical research is a matter of justice and will assist in reducing inequities and advancing their health and human dignity.
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    Assessment of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) Program for Improving Quality of Care for Transient Ischemic Attack: A Nonrandomized Cluster Trial
    (American Medical Association, 2020-09-08) Bravata, Dawn M.; Myers, Laura J.; Perkins, Anthony J.; Zhang, Ying; Miech, Edward J.; Rattray, Nicholas A.; Penney, Lauren S.; Levine, Deborah; Sico, Jason J.; Cheng, Eric M.; Damush, Teresa M.; Medicine, School of Medicine
    Importance Patients with transient ischemic attack (TIA) are at high risk of recurrent vascular events. Timely management can reduce that risk by 70%; however, gaps in TIA quality of care exist. Objective To assess the performance of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) intervention to improve TIA quality of care. Design, Setting, and Participants This nonrandomized cluster trial with matched controls evaluated a multicomponent intervention to improve TIA quality of care at 6 diverse medical centers in 6 geographically diverse states in the US and assessed change over time in quality of care among 36 matched control sites (6 control sites matched to each PREVENT site on TIA patient volume, facility complexity, and quality of care). The study period (defined as the data period) started on August 21, 2015, and extended to May 12, 2019, including 1-year baseline and active implementation periods for each site. The intervention targeted clinical teams caring for patients with TIA. Intervention The quality improvement (QI) intervention included the following 5 components: clinical programs, data feedback, professional education, electronic health record tools, and QI support. Main Outcomes and Measures The primary outcome was the without-fail rate, which was calculated as the proportion of veterans with TIA at a specific facility who received all 7 guideline-recommended processes of care for which they were eligible (ie, anticoagulation for atrial fibrillation, antithrombotic use, brain imaging, carotid artery imaging, high- or moderate-potency statin therapy, hypertension control, and neurological consultation). Generalized mixed-effects models with multilevel hierarchical random effects were constructed to evaluate the intervention associations with the change in the mean without-fail rate from the 1-year baseline period to the 1-year intervention period. Results Six facilities implemented the PREVENT QI intervention, and 36 facilities were identified as matched control sites. The mean (SD) age of patients at baseline was 69.85 (11.19) years at PREVENT sites and 71.66 (11.29) years at matched control sites. Most patients were male (95.1% [154 of 162] at PREVENT sites and 94.6% [920 of 973] at matched control sites at baseline). Among the PREVENT sites, the mean without-fail rate improved substantially from 36.7% (58 of 158 patients) at baseline to 54.0% (95 of 176 patients) during a 1-year implementation period (adjusted odds ratio, 2.10; 95% CI, 1.27-3.48; P = .004). Comparing the change in quality at the PREVENT sites with the matched control sites, the improvement in the mean without-fail rate was greater at the PREVENT sites than at the matched control sites (36.7% [58 of 158 patients] to 54.0% [95 of 176 patients] [17.3% absolute improvement] vs 38.6% [345 of 893 patients] to 41.8% [363 of 869 patients] [3.2% absolute improvement], respectively; absolute difference, 14%; P = .008). Conclusions and Relevance The implementation of this multifaceted program was associated with improved TIA quality of care across the participating sites. The PREVENT QI program is an example of a health care system using QI strategies to improve performance, and may serve as a model for other health systems seeking to provide better care. Trial Registration ClinicalTrials.gov Identifier: NCT02769338 Go to: Introduction Approximately 8500 veterans with transient ischemic attack (TIA) or ischemic stroke are cared for in Department of Veterans Affairs (VA) emergency departments (EDs) or inpatient wards annually in the United States.1 Patients with TIA generally present with transient neurological symptoms of a presumed ischemic cause.2 Patients with TIA are at a high risk of recurrent vascular events3,4,5; however, delivery of timely TIA care can reduce that risk by up to 70%.6,7,8,9 Despite the known benefits of timely TIA care, gaps in TIA quality of care exist in both private-sector US hospitals10 and VA facilities.11,12 In a learning health care system, “clinical informatics, incentives, and culture are aligned to promote continuous improvement and innovation, with best practices seamlessly embedded in the delivery process and new knowledge captured as an integral by-product of the delivery experience.”13(p136) Within a learning health care system, health care teams respond to quality problems by using quality improvement (QI) strategies and systems redesign approaches to improve performance, depending on the complexity and scope of the problem.14 The objective of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) trial was to evaluate a multicomponent QI intervention to improve the quality of TIA care.15 The PREVENT intervention was designed to align with the learning health care system model.13,15
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    Executive Summary: International Clinical Practice Guidelines for Pediatric Ventilator Liberation, A PALISI Network Document
    (American Thoracic Society Journals, 2022-08-15) Abu-Sultaneh, Samer; Iyer, Narayan Prabhu; Fernández, Analía; Gaies, Michael; González-Dambrauskas, Sebastián; Hotz, Justin Christian; Kneyber, Martin C.J.; López-Fernández, Yolanda M.; Rotta, Alexandre T.; Werho, David K.; Baranwal, Arun Kumar; Blackwood, Bronagh; Craven, Hannah J.; Curley, Martha A.Q.; Essouri, Sandrine; Fioretto, Jose Roberto; Hartmann, Silvia M.M.; Jouvet, Philippe; Korang, Steven Kwasi; Rafferty, Gerrard F.; Ramnarayan, Padmanabhan; Rose, Louise; Tume, Lyvonne N.; Whipple, Elizabeth C.; Wong, Judith Ju Ming; Emeriaud, Guillaume; Mastropietro, Christopher W; Napolitano, Natalie; Newth, Christopher J.L.; Khemani, Robinder G.
    RATIONALE: Pediatric specific ventilator liberation guidelines are lacking despite the many studies exploring elements of extubation readiness testing. The lack of clinical practice guidelines has led to significant and unnecessary variation in methods used to assess pediatric patients' readiness for extubation. METHODS: Twenty-six international experts comprised a multi-professional panel to establish pediatric specific ventilator liberation clinical practice guidelines, focusing on acutely hospitalized children receiving invasive mechanical ventilation for more than 24 hours. Eleven key questions were identified and first prioritized using the Modified Convergence of Opinion on Recommendations and Evidence. Systematic review was conducted for questions which did not meet an a-priori threshold of ≥80% agreement, with Grading of Recommendations, Assessment, Development, and Evaluation methodologies applied to develop the guidelines. The panel evaluated the evidence, drafted, and voted on the recommendations. MEASUREMENTS AND MAIN RESULTS: Three questions related to systematic screening, using an extubation readiness testing bundle and use of a spontaneous breathing trial as part of the bundle met Modified Convergence of Opinion on Recommendations criteria of ≥80% agreement. For the remaining 8 questions, 5 systematic reviews yielded 12 recommendations related to the methods and duration of spontaneous breathing trials; measures of respiratory muscle strength; assessment of risk of post-extubation upper airway obstruction and its prevention; use of post-extubation non-invasive respiratory support; and sedation. Most recommendations were conditional and based on low to very low certainty of evidence. CONCLUSION: This clinical practice guideline provides a conceptual framework with evidence-based recommendations for best practices related to pediatric ventilator liberation.
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    Implementing measurement-based care (iMBC) for depression in community mental health: a dynamic cluster randomized trial study protocol
    (Springer (Biomed Central Ltd.), 2015) Lewis, Cara C.; Scott, Kelli; Marti, C. Nathan; Marriott, Brigid R.; Kroenke, Kurt; Putz, John W.; Mendel, Peter; Rutkowski, David; Department of Medicine, IU School of Medicine
    BACKGROUND: Measurement-based care is an evidence-based practice for depression that efficiently identifies treatment non-responders and those who might otherwise deteriorate [1]. However, measurement-based care is underutilized in community mental health with data suggesting fewer than 20 % of behavioral health providers using this practice to inform treatment. It remains unclear whether standardized or tailored approaches to implementation are needed to optimize measurement-based care fidelity and penetration. Moreover, there is some suggestion that prospectively tailored interventions that are designed to fit the dynamic context may optimize public health impact, though no randomized trials have yet tested this notion [2]. This study will address the following three aims: (1) To compare the effect of standardized versus tailored MBC implementation on clinician-level and client-level outcomes; (2) To identify contextual mediators of MBC fidelity; and (3) To explore the impact of MBC fidelity on client outcomes. METHODS/DESIGN: This study is a dynamic cluster randomized trial of standardized versus tailored measurement-based care implementation in Centerstone, the largest provider of community-based mental health services in the USA. This prospective, mixed methods implementation-effectiveness hybrid design allows for evaluation of the two conditions on both clinician-level (e.g., MBC fidelity) and client-level (depression symptom change) outcomes. Central to this investigation is the focus on identifying contextual factors (e.g., attitudes, resources, process, etc.) that mediate MBC fidelity and optimize client outcomes. DISCUSSION: This study will contribute generalizable and practical strategies for implementing systematic symptom monitoring to inform and enhance behavioral healthcare. TRIAL REGISTRATION: Clinicaltrials.gov NCT02266134 .