Implementation Lessons From a Randomized Trial Integrating Community Asthma Education for Children.
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ABSTRACT:
SUBMITTER: Martin MA
PROVIDER: S-EPMC8329939 | biostudies-literature | 2020 Apr-Jun
REPOSITORIES: biostudies-literature
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Implementation Lessons From a Randomized Trial Integrating Community Asthma Education for Children.
Martin Molly A MA Bisarini Reymundo R Roy Angkana A Mosnaim Giselle G Rosales Genesis G Weinstein Sally S Walton Surrey M SM
The Journal of ambulatory care management 20200401 2
This study characterized and compared the implementation of clinically integrated community health workers (CHWs) to a certified asthma educator (AE-C) for low-income children with asthma. In the AE-C arm (N = 115), 51.3% completed at least one in-clinic education session. In the CHW arm (N = 108), 722 home visits were completed. The median number of visits was 7 (range, 0-17). Scheduled in-clinic asthma education may not be the optimal intervention for this patient population. CHW visit complet ...[more]
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Project description:BackgroundMost children with asthma have poor inhaler technique, with detrimental morbidity effects. Guidelines recommend clinicians provide inhaler education at every opportunity, yet resources are limited. A low-cost, technology-based intervention-Virtual Teach-to-Goal (V-TTG)-was developed to deliver tailored inhaler technique education with high fidelity.ObjectiveTo evaluate whether V-TTG leads to less inhaler misuse among children with asthma who are hospitalized vs brief intervention (BI, reading steps aloud).MethodsA single-center randomized controlled trial of V-TTG vs BI was conducted with 5-to-10-year-old children with asthma hospitalized between January 2019 and February 2020. Inhaler technique was assessed pre- and post-education using 12-step validated checklists (misuse: < 10 steps correct).ResultsAmong 70 children enrolled, mean age was 7.8 years (SD = 1.6). Most (86%) were Black. Most had an emergency department visit (94%) or hospitalization (90%) in the previous year. At baseline, nearly all children misused inhalers (96%). The proportion of children with inhaler misuse decreased significantly in V-TTG (100%→74%, P = .002) and BI (92%→69%, P = .04) groups, with no difference between groups at both time points (P = .2 and .9). On average, children performed 1.5 more steps correctly (SD = 2.0), with greater improvement with V-TTG (mean [SD] = 1.7 [1.6]) vs BI (mean [SD] = 1.4 [2.3]), though not significant (P = .6). Concerning pre and post technique, older children were significantly more likely than younger children to show more correct steps (mean change = 1.9 vs 1.1, P = .002).ConclusionA technology-based intervention for tailored inhaler education led to improved technique among children, similarly to reading steps aloud. Older children saw greater benefits. Future studies should evaluate the V-TTG intervention across diverse populations and disease severities to identify the greatest impact.Clinical trial registrationNCT04373499.
| S-EPMC10440276 | biostudies-literature
Project description:BackgroundChatGPT is a natural language processing model developed by OpenAI, which can be iteratively updated and optimized to accommodate the changing and complex requirements of human verbal communication.ObjectiveThe study aimed to evaluate ChatGPT's accuracy in answering orthopedics-related multiple-choice questions (MCQs) and assess its short-term effects as a learning aid through a randomized controlled trial. In addition, long-term effects on student performance in other subjects were measured using final examination results.MethodsWe first evaluated ChatGPT's accuracy in answering MCQs pertaining to orthopedics across various question formats. Then, 129 undergraduate medical students participated in a randomized controlled study in which the ChatGPT group used ChatGPT as a learning tool, while the control group was prohibited from using artificial intelligence software to support learning. Following a 2-week intervention, the 2 groups' understanding of orthopedics was assessed by an orthopedics test, and variations in the 2 groups' performance in other disciplines were noted through a follow-up at the end of the semester.ResultsChatGPT-4.0 answered 1051 orthopedics-related MCQs with a 70.60% (742/1051) accuracy rate, including 71.8% (237/330) accuracy for A1 MCQs, 73.7% (330/448) accuracy for A2 MCQs, 70.2% (92/131) accuracy for A3/4 MCQs, and 58.5% (83/142) accuracy for case analysis MCQs. As of April 7, 2023, a total of 129 individuals participated in the experiment. However, 19 individuals withdrew from the experiment at various phases; thus, as of July 1, 2023, a total of 110 individuals accomplished the trial and completed all follow-up work. After we intervened in the learning style of the students in the short term, the ChatGPT group answered more questions correctly than the control group (ChatGPT group: mean 141.20, SD 26.68; control group: mean 130.80, SD 25.56; P=.04) in the orthopedics test, particularly on A1 (ChatGPT group: mean 46.57, SD 8.52; control group: mean 42.18, SD 9.43; P=.01), A2 (ChatGPT group: mean 60.59, SD 10.58; control group: mean 56.66, SD 9.91; P=.047), and A3/4 MCQs (ChatGPT group: mean 19.57, SD 5.48; control group: mean 16.46, SD 4.58; P=.002). At the end of the semester, we found that the ChatGPT group performed better on final examinations in surgery (ChatGPT group: mean 76.54, SD 9.79; control group: mean 72.54, SD 8.11; P=.02) and obstetrics and gynecology (ChatGPT group: mean 75.98, SD 8.94; control group: mean 72.54, SD 8.66; P=.04) than the control group.ConclusionsChatGPT answers orthopedics-related MCQs accurately, and students using it excel in both short-term and long-term assessments. Our findings strongly support ChatGPT's integration into medical education, enhancing contemporary instructional methods.Trial registrationChinese Clinical Trial Registry Chictr2300071774; https://www.chictr.org.cn/hvshowproject.html ?id=225740&v=1.0.
| S-EPMC11372336 | biostudies-literature
Project description:Objectives. To compare asthma control for children receiving either community health worker (CHW) or certified asthma educator (AE-C) services. Methods. The Asthma Action at Erie Trial is a comparative effectiveness trial that ran from 2016 to 2019 in Cook County, Illinois. Participants (aged 5‒16 years with uncontrolled asthma) were randomized to 10 home visits from clinically integrated asthma CHWs or 2 in-clinic sessions from an AE-C. Results. Participants (n = 223) were mainly Hispanic (85%) and low-income. Both intervention groups showed significant improvement in asthma control scores over time. Asthma control was maintained after interventions ended. The CHW group experienced a greater improvement in asthma control scores. One year after intervention cessation, the CHW group had a 42% reduction in days of activity limitation relative to the AE-C group (b = 0.58; 95% confidence interval = 0.35, 0.96). Conclusions. Both interventions were associated with meaningful improvements in asthma control. Improvements continued for 1 year after intervention cessation and were stronger with the CHW intervention. Public Health Implications. Clinically integrated asthma CHW and AE-C services that do not provide home environmental remediation equipment may improve and sustain asthma control.
| S-EPMC8355214 | biostudies-literature
Project description:BackgroundThe NHLBI-sponsored Sickle Cell Disease Clinical Research Network (SCDCRN) conducted a multi-center, acute intervention randomized clinical trial of two methods of Patient Controlled Analgesia for acute pain. This trial was terminated early due to low enrollment. We analyzed the perceived barriers and recruitment difficulties as reported by the coordinators and principal investigators.MethodsParticipating sites completed a missed eligibility log of subjects admitted in pain crisis throughout the study and a survey at the end of the trial. The survey covered site-specific factors, policies, and procedures in study implementation, recruitment strategies, and eligibility factors. The New England Research Institutes (NERI) collected de-identified surveys from 31 respondents at 29 of 31 participating sites.ResultsFrom December 2009 to June 2010, 1116 patient encounters for SCD and pain occurred at participating institutions: 38 subjects were enrolled (14 pediatric and 24 adults) and 34 completed the trial, below the projected 278 subjects. Fourteen sites enrolled subjects and seventeen did not. Recruitment barriers included insufficient staff, subject ineligibility or in too much pain to consent, competing protocols, and concerns regarding pain control. Recruitment methods were referrals from urgent care, SCD clinics and in house databases. No use of media or outside physicians was reported.ConclusionWe identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments' involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials.
| S-EPMC3577351 | biostudies-literature
Project description:ImportanceUnhealthy alcohol use is common and affects morbidity and mortality but is often neglected in medical settings, despite guidelines for both prevention and treatment.ObjectiveTo test an implementation intervention to increase (1) population-based alcohol-related prevention with brief interventions and (2) treatment of alcohol use disorder (AUD) in primary care implemented with a broader program of behavioral health integration.Design, setting, and participantsThe Sustained Patient-Centered Alcohol-Related Care (SPARC) trial was a stepped-wedge cluster randomized implementation trial, including 22 primary care practices in an integrated health system in Washington state. Participants consisted of all adult patients (aged ≥18 years) with primary care visits from January 2015 to July 2018. Data were analyzed from August 2018 to March 2021.InterventionsThe implementation intervention included 3 strategies: practice facilitation; electronic health record decision support; and performance feedback. Practices were randomly assigned launch dates, which placed them in 1 of 7 waves and defined the start of the practice's intervention period.Main outcomes and measuresCoprimary outcomes for prevention and AUD treatment were (1) the proportion of patients who had unhealthy alcohol use and brief intervention documented in the electronic health record (brief intervention) for prevention and (2) the proportion of patients who had newly diagnosed AUD and engaged in AUD treatment (AUD treatment engagement). Analyses compared monthly rates of primary and intermediate outcomes (eg, screening, diagnosis, treatment initiation) among all patients who visited primary care during usual care and intervention periods using mixed-effects regression.ResultsA total of 333 596 patients visited primary care (mean [SD] age, 48 [18] years; 193 583 [58%] female; 234 764 [70%] White individuals). The proportion with brief intervention was higher during SPARC intervention than usual care periods (57 vs 11 per 10 000 patients per month; P < .001). The proportion with AUD treatment engagement did not differ during intervention and usual care (1.4 vs 1.8 per 10 000 patients; P = .30). The intervention increased intermediate outcomes: screening (83.2% vs 20.8%; P < .001), new AUD diagnosis (33.8 vs 28.8 per 10 000; P = .003), and treatment initiation (7.8 vs 6.2 per 10 000; P = .04).Conclusions and relevanceIn this stepped-wedge cluster randomized implementation trial, the SPARC intervention resulted in modest increases in prevention (brief intervention) but not AUD treatment engagement in primary care, despite important increases in screening, new diagnoses, and treatment initiation.Trial registrationClinicalTrials.gov Identifier: NCT02675777.
| S-EPMC9972247 | biostudies-literature
Project description:IntroductionAsthma is the most common chronic disease among children worldwide, with 80% of asthma-related deaths occurring in low- and middle-income countries (LMICs). While evidence-based guidelines exist for asthma treatment and management, adoption of guideline-based practices is low in high-income country and LMIC settings alike. While asthma prevalence among children and adolescents in Lima, Peru is in the range of 13%-19.6%, our data suggest that < 5% of children in low-resource communities are currently taking guideline-based therapies. There is an urgent need for effective, locally tailored solutions to address the asthma treatment gap in low-income communities in Peru.MethodsThis study aims to develop and test a locally adapted intervention package to improve adoption of self-management practices and utilization of preventive health services for asthma among children in Lima Norte. The intervention package was designed using a systematic, theory-based framework (Capability, Opportunity, Motivation - Behavior Framework) and is rooted in a multi-phased formative research approach. The main study design is an individually randomized implementation-effectiveness hybrid trial enrolling 110 children aged 5-17 years with asthma and their caregivers. Families allocated to the treatment group receive the supported self-management intervention package, while families allocated to the control group receive the standard of care plus asthma education. We will follow participants monthly for six months and evaluate asthma control (Asthma Control Test), healthcare utilization, and medication adherence (Adherence to Refills and Medications Scale). Disease-specific quality of life for children (Pediatric Asthma Quality of Life Questionnaire) and caregivers (Pediatric Asthma Caregiver's Quality of Life Questionnaire) will be evaluated at baseline, 3 months, and 6 months. We will also evaluate acceptability, feasibility, and fidelity of the intervention using mixed methods approaches.DiscussionThe long-term goal of this study is to disseminate locally appropriate asthma management strategies in LMIC settings. This study will contribute to the body of knowledge surrounding approaches for developing and evaluating intervention strategies for asthma using systematic, theory-based approaches grounded in local context. Such strategies have the potential to inform the development and adaptation of appropriate and scalable solutions for asthma management in LMIC settings.Trial registrationClinicalTrials.gov, NCT03986177. Registered on 14 June 2019.
| S-EPMC7199375 | biostudies-literature
Project description:As a result of the previous part of this trial, many patients with cardiovascular disease were expected to receive a statin for the first time. In order to provide these patients with comprehensive information on statins, as recommended by professional guidance, education at first and second dispensing of statins had to be implemented. This study was designed to assess the effectiveness of an intensive implementation program targeted at pharmacy project assistants on the frequency of providing education at first dispensing (EAFD) and education at second dispensing (EASD) of statins in community pharmacies.The participating community pharmacies were clustered on the basis of local collaboration, were numbered by a research assistant and subsequently an independent statistician performed a block randomization, in which the cluster size (number of pharmacies in each cluster) was balanced. The pharmacies in the control group received a written manual on the implementation of EAFD and EASD; the pharmacies in the intervention group received intensive support for the implementation. The impact of the intensive implementation program on the implementation process and on the primary outcomes was examined in a random coefficient logistic regression model, which took into account that patients were grouped within pharmacy clusters.Of the 37 pharmacies in the intervention group, 17 pharmacies (50%) provided EAFD and 12 pharmacies (35.3%) provided EASD compared to 14 pharmacies (45.2%, P = 0.715) and 12 pharmacies (38.7%, P = 0.899), respectively, of the 34 pharmacies in the control group. In the intervention group a total of 72 of 469 new statin users (15.4%) received education and 49 of 393 patients with a second statin prescription (12.5%) compared to 78 of 402 new users (19.4%, P = 0.944) and 35 of 342 patients with a second prescription (10.2%, P = 0.579) in the control group.The intensive implementation program did not increase the frequency of providing EAFD and EASD of statins in community pharmacies.clinicaltrials.gov NCT00509717.
| S-EPMC3258215 | biostudies-literature
Project description:ContextAsymptomatic gastroesophageal reflux (GER) is prevalent in children with asthma. Untreated GER has been postulated to be a cause of inadequate asthma control in children despite inhaled corticosteroid treatment, but it is not known whether treatment with proton pump inhibitors improves asthma control.ObjectiveTo determine whether lansoprazole is effective in reducing asthma symptoms in children without overt GER.Design, setting, and participantsThe Study of Acid Reflux in Children With Asthma, a randomized, masked, placebo-controlled, parallel clinical trial that compared lansoprazole with placebo in children with poor asthma control who were receiving inhaled corticosteroid treatment. Three hundred six participants enrolled from April 2007 to September 2010 at 19 US academic clinical centers were followed up for 24 weeks. A subgroup had an esophageal pH study before randomization.InterventionParticipating children were randomly assigned to receive either lansoprazole, 15 mg/d if weighing less than 30 kg or 30 mg/d if weighing 30 kg or more (n = 149), or placebo (n = 157).Main outcome measuresThe primary outcome measure was change in Asthma Control Questionnaire (ACQ) score (range, 0-6; a 0.5-unit change is considered clinically meaningful). Secondary outcome measures included lung function measures, asthma-related quality of life, and episodes of poor asthma control.ResultsThe mean age was 11 years (SD, 3 years). The mean difference in change (lansoprazole minus placebo) in the ACQ score was 0.2 units (95% CI, 0.0-0.3 units). There were no statistically significant differences in the mean difference in change for the secondary outcomes of forced expiratory volume in the first second (0.0 L; 95% CI, -0.1 to 0.1 L), asthma-related quality of life (-0.1; 95% CI, -0.3 to 0.1), or rate of episodes of poor asthma control (relative risk, 1.2; 95% CI, 0.9-1.5). Among the 115 children with esophageal pH studies, the prevalence of GER was 43%. In the subgroup with a positive pH study, no treatment effect for lansoprazole vs placebo was observed for any asthma outcome. Children treated with lansoprazole reported more respiratory infections (relative risk, 1.3 [95% CI, 1.1-1.6]).ConclusionIn this trial of children with poorly controlled asthma without symptoms of GER who were using inhaled corticosteroids, the addition of lansoprazole, compared with placebo, improved neither symptoms nor lung function but was associated with increased adverse events.Trial registrationclinicaltrials.gov Identifier: NCT00442013.
| S-EPMC4153372 | biostudies-literature
Project description:BackgroundData on pediatric asthma morbidity and effective environmental interventions in U.S. agricultural settings are few. We evaluated the effectiveness of HEPA air cleaners on asthma morbidity among a cohort of rural Latino children.MethodsSeventy-five children with poorly controlled asthma and living in non-smoking homes were randomly assigned to asthma education alone or along with HEPA air cleaners placed in their sleeping area and home living room. The Asthma Control Test (ACT) score, asthma symptoms in prior 2 weeks, unplanned clinical utilization, creatinine-adjusted urinary leukotriene E4 (uLTE4 [ng/mg]), and additional secondary outcomes were evaluated at baseline, six, and 12 months. Group differences were assessed using multivariable-adjusted generalized estimating equations. Incident rate ratios of ever experiencing the metrics of poorer asthma health during follow-up (suboptimal asthma management) were estimated using Poisson regression models in secondary analysis.ResultsMean child age was 9.2 and 8.6 years in intervention and control groups, respectively, and two-thirds of participants were male. Primary analysis of repeated measures of ACT score did not differ between groups (HEPA group mean change compared to controls 10% [95% CI: - 12-39%]). A suggestion of greater decrease in uLTE4 (ng/mg creatinine) was observed (- 10% [95% CI: - 20 -1%]). Secondary analysis showed children with HEPAs were less likely to have an ACT score meeting a clinically defined cutoff for poorly controlled asthma using repeated measures (IRR: 0.45 [95% CI: 0.21-0.97]). In Poisson models, intervention participants had reduced risk of ever meeting this cutoff (IRR: 0.43 [95% CI: 0.21-0.89]), ever having symptoms in the past 2 weeks (IRR: 0.71 [95% CI: 0.52-0.98]), and lower risk of any unplanned clinical utilization (IRR: 0.35 [95% CI: 0.13-0.94]) compared to control participants.DiscussionThe HAPI study showed generally improved outcomes among children in the HEPA air cleaner group. However, primary analyses did not meet statistical significance and many outcomes were subjective (self-report) in this unblinded study, so findings must be interpreted cautiously. HEPA air cleaners may provide additional benefit for child asthma health where traditional asthmagens (traffic, tobacco smoke) are not prominent factors, but larger studies with more statistical power and blinded designs are needed.Trial registrationClinicalTrials.gov Identifier: NCT04919915 . Date of retrospective registration: May 19, 2021.
| S-EPMC8722199 | biostudies-literature
Project description:A World Health Organization (WHO)/United Nations Children's Fund (UNICEF) (2009) joint statement recommended home visits by community-based agents as a strategy to improve newborn survival, based on promising results from Asia. This article presents detailed evaluation of community volunteer assessment and referral implemented within the Ghana Newhints home visits cluster-Randomized Controlled Trial (RCT). It highlights the lessons learned to inform implementation/scale-up of this model in similar settings. The evaluation used a conceptual framework adopted for increasing access to care for sick newborns and involves three main steps, each with a specific goal and key requirements to achieving this. These steps are: sick newborns are identified within communities and referred; families comply with referrals and referred babies receive appropriate management at health facilities. Evaluation data included interviews with 4006 recently delivered mothers; records on 759 directly observed volunteer assessments and 52 validation of supervisors' assessments; newborn care quality assessment in 86 health facilities and in-depth interviews (IDIs) with 55 mothers, 21 volunteers and 15 health professionals. Assessment accuracy of volunteers against supervisors and physician was assessed using Kappa (agreement coefficient). IDIs were analysed by generating and indexing into themes, and exploring relationships between themes and their contextual interpretations. This evaluation demonstrated that identifying, understanding and implementing the key requirements for success in each step of volunteer assessment and referrals was pivotal to success. In Newhints, volunteers (CBSVs) were trusted by families, their visits were acceptable and they engaged mothers/families in decisions, resulting in unprecedented 86% referral compliance and increased (55-77%) care seeking for sick newborns. Poor facility care quality, characterized by poor health worker attitudes, limited the mortality reduction. The important implication for future implementation of home visits in similar settings is that, with 100% specificity but 80% sensitivity of referral decisions, volunteers might miss some danger signs but if successful implementation must translate into mortality reductions, concurrent improvement in facility newborn care quality is imperative.
| S-EPMC4202912 | biostudies-literature