Cluster-randomized Clinical Trial Research Articles

Cost-effectiveness analysis of procalcitonin and lung ultrasonography guided antibiotic prescriptions in primary care.

Antimicrobial resistance comes with high morbidity and mortality burden, and ultimately high impact on healthcare and social costs. Efficient strategies are needed to limit antibiotic overuse. This paper investigates the cost-effectiveness of testing patients with lower respiratory tract infection with procalcitonin, either at the point-of-care only or combined with lung ultrasonography. These diagnostic tools help detect the presence of bacterial pneumonia, guiding prescription decisions. The clinical responses of these strategies were studied in the primary care setting. Evidence is needed on their cost-effectiveness. We used data from a cluster-randomized bi-centric clinical trial conducted in Switzerland and estimated patient-level costs using data on resource use to which we applied Swiss tariffs. Combining the incremental costs of the two strategies and the reduction in the 28-days antibiotic prescription rate (APR) compared to usual care, we calculated Incremental Cost-Effectiveness Ratios (ICER). We also used the Cost-Effectiveness Acceptability Curve as an analytical decision-making tool. The robustness of the findings is ensured by Probabilistic Sensitivity Analysis and scenario analysis. In the base case scenario, the ICER compared to usual care is $2.3 per percentage point (pp) reduction in APR for the procalcitonin group, and $4.4 for procalcitonin-ultrasound combined. Furthermore, we found that for a willingness to pay per patient of more than $2 per pp reduction in the APR, procalcitonin is the strategy with the highest probability to be cost-effective. Our findings suggest that testing patients with respiratory symptoms with procalcitonin to guide antibiotic prescription in the primary care setting represents good value for money.

Diagnostic Strategies for Restorations Management: A 70-Month RCT.

We aimed to evaluate the impact of 2 visual diagnostic strategies for assessing secondary caries and managing permanent posterior restorations on long-term survival. We conducted a diagnostic cluster-randomized clinical trial with 2 parallel groups using different diagnostic strategies: (C+AS) based on caries assessment, marginal adaptation, and marginal staining aspects of the FDI (World Dental Federation) criteria and (C) based on caries assessment using the Caries Associated with Restorations or Sealants (CARS) criteria described by the International Caries Detection and Assessment System (ICDAS). The treatment for the restoration was conducted based on the decision made following the allocated diagnostic strategy. The restorations were then clinically reevaluated for up to 71 mo. The primary outcome was restoration failure (including tooth-level failure: pain, endodontic treatment, and extraction). Cox regression analyses with shared frailty were conducted in the intention-to-treat population, and hazard ratios (HRs) and 95% confidence intervals (95% CIs) were derived. We included 727 restorations from 185 participants and reassessed 502 (69.1%) restorations during follow-up. The evaluations occurred between 6 and 71 mo. At baseline, C led to almost 4 times fewer interventions compared with the C+AS strategy. A total of 371 restorations were assessed in the C group, from which 31 (8.4%) were repaired or replaced. In contrast, the C+AS group had 356 restorations assessed, from which 113 (31.7%) were repaired or replaced. During follow-up, 34 (9.2%) failures were detected in the restorations allocated to the C group and 30 (8.4%) allocated to the C+AS group in the intention-to-treat population, with no significant difference between the groups (HR = 0.83; 95% CI = 0.51 to 1.38; P = 0.435, C+AS as reference). In conclusion, a diagnostic strategy focusing on marginal defects results in more initial interventions but does not improve longevity over the caries-focused strategy, suggesting the need for more conservative approaches.

Association between patient activation level and functional outcomes in older adults with hip fractures

BackgroundHip fractures can significantly impact older adults' mobility and function. Effective rehabilitation is crucial to help them regain independence and quality of life. However, little is known about the association between patient activation and hip fracture rehabilitation. This study aims to assess the association between the PAM-13 scores and the level of physical function, mobility, and activities of daily living in older adults following a hip fracture rehabilitation program. MethodAn exploratory outcome study from a cluster-randomized stepped-wedge clinical controlled trial. Two hundred thirty-nine patients were classified into four Patient Activation Measure-Levels (PAM-13) according to their PAM-13 scores, reflecting their confidence and preparedness to manage their health. Level 1 represents the lowest level of confidence. The patient's mobility, function, and daily activities were evaluated at discharge and after 12 and 24 weeks. ResultsThe cohort had a median age of 78; 67% were female, and 50% lived alone. There were no significant differences in demographics between the PAM-Levels. PAM-Level 1 patients had longer hospital stays and lower mobility scores than PAM-Level 4 patients. However, all patients improved over time, and higher initial PAM levels resulted in better outcomes. PAM-Level 1 patients improved in Time Up and Go score from a median score of 54 seconds to 14 seconds at 24 weeks, while PAM-Level 4 patients improved from 26 to 9 seconds. ConclusionOur study found an association between PAM levels and functional outcomes in hip fracture rehabilitation. Patients with higher activation levels had better mobility and functional outcomes.

Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): a nested cross-sectional assessment of falls risk within a cluster randomised trial

BackgroundTo investigate the feasibility of using the Stopping Elderly Accidents, Deaths and Injuries (STEADI) Falls Risk Tool Kit during community-based eye health screenings to assess falls risk of participants enrolled...

Alerta Cannabis: A Tailored-Computer Web-Based Program for the Prevention of Cannabis Use in Adolescents: A Cluster-Randomized Controlled Trial Protocol

BackgroundThe growing use of cannabis in adolescence is a public health problem that must be addressed through prevention. In Spain, the average age of initiation of cannabis use in the adolescent population is 14.8 years. At 14 years, the lifetime prevalence of cannabis use is 11.7%, which increases to 51.,5% at the age of 18; the prevalence of cannabis use in the population aged 14 to 18 years is 28.6%, a figure that must be tried to reduce, that is why this school prevention program is proposed: Alerta Cannabis.MethodsThe Alerta Cannabis research project consists of design, implementation, and evaluation. In the first phase, a computer-tailored eHealth program (Alerta Cannabis) is developed based on the I-Change Model, an integrated model based on three main behavioral change processes: awareness, motivation, and action. This program consists of four 30-minute sessions that will provide culturally adapted and personalized advice to motivate students not to use cannabis through text feedback, animations, and gamification techniques. This phase will also include usability testing. In the implementation phase, secondary school students from Western Andalusia, Spain (Seville, Cádiz, Huelva, and Córdoba) and Eastern Andalusia (Jaén, Málaga, and Granada) will be randomized to an experimental condition (EC) or a control condition (CC) for a cluster randomized clinical trial (CRCT). Each condition will have 35 classes within 8 schools. GI will receive the online intervention Alerta Cannabis. EC and CC will have to fill out a questionnaire at baseline, six months, and twelve months of follow-up. In the last phase, the effect of Alerta Cannabis is evaluated. The primary outcomes are the lifetime prevalence of cannabis use and its use in the last 30 days and at 6 months. At 12 months of follow-up, the prevalence in the last 12 months will also be assessed. The secondary outcome is the intention to use cannabis.DiscussionThe study tests the effect of the innovative program specifically aimed to reduce the use of cannabis in the adolescent population through eHealth in Spain. The findings aim to develop and implement evidence-based cannabis prevention interventions, which could support school prevention, for instance, the assistance of school nurses. If the program proves to be effective, it could be useful to prevent cannabis use on a national and international scale.Trial registrationNCT05849636. Date of registration: March 16, 2023.

Integrated Hepatitis C–Opioid Use Disorder Care Through Facilitated Telemedicine

Facilitated telemedicine may promote hepatitis C virus elimination by mitigating geographic and temporal barriers. To compare sustained virologic responses for hepatitis C virus among persons with opioid use disorder treated through facilitated telemedicine integrated into opioid treatment programs compared with off-site hepatitis specialist referral. Prospective, cluster randomized clinical trial using a stepped wedge design. Twelve programs throughout New York State included hepatitis C-infected participants (n = 602) enrolled between March 1, 2017, and February 29, 2020. Data were analyzed from December 1, 2022, through September 1, 2023. Hepatitis C treatment with direct-acting antivirals through comanagement with a hepatitis specialist either through facilitated telemedicine integrated into opioid treatment programs (n = 290) or standard-of-care off-site referral (n = 312). The primary outcome was hepatitis C virus cure. Twelve programs began with off-site referral, and every 9 months, 4 randomly selected sites transitioned to facilitated telemedicine during 3 steps without participant crossover. Participants completed 2-year follow-up for reinfection assessment. Inclusion criteria required 6-month enrollment in opioid treatment and insurance coverage of hepatitis C medications. Generalized linear mixed-effects models were used to test for the intervention effect, adjusted for time, clustering, and effect modification in individual-based intention-to-treat analysis. Among 602 participants, 369 were male (61.3%); 296 (49.2%) were American Indian or Alaska Native, Asian, Black or African American, multiracial, or other (ie, no race category was selected, with race data collected according to the 5 standard National Institutes of Health categories); and 306 (50.8%) were White. The mean (SD) age of the enrolled participants in the telemedicine group was 47.1 (13.1) years; that of the referral group was 48.9 (12.8) years. In telemedicine, 268 of 290 participants (92.4%) initiated treatment compared with 126 of 312 participants (40.4%) in referral. Intention-to-treat cure percentages were 90.3% (262 of 290) in telemedicine and 39.4% (123 of 312) in referral, with an estimated logarithmic odds ratio of the study group effect of 2.9 (95% CI, 2.0-3.5; P < .001) with no effect modification. Observed cure percentages were 246 of 290 participants (84.8%) in telemedicine vs 106 of 312 participants (34.0%) in referral. Subgroup effects were not significant, including fibrosis stage, urban or rural participant residence location, or mental health (anxiety or depression) comorbid conditions. Illicit drug use decreased significantly (referral: 95% CI, 1.2-4.8; P = .001; telemedicine: 95% CI, 0.3-1.0; P < .001) among cured participants. Minimal reinfections (n = 13) occurred, with hepatitis C virus reinfection incidence of 2.5 per 100 person-years. Participants in both groups rated health care delivery satisfaction as high or very high. Opioid treatment program-integrated facilitated telemedicine resulted in significantly higher hepatitis C virus cure rates compared with off-site referral, with high participant satisfaction. Illicit drug use declined significantly among cured participants with minimal reinfections. ClinicalTrials.gov Identifier: NCT02933970.

Manhattan Vision Screening and Follow-up Study (NYC-SIGHT): Vision and refractive error results

ABSTRACT Clinical relevance Optometrists can play a key role in providing access to eye care in underserved populations by organising community-based eye health screenings that include optometric exams to detect vision impairment and uncorrected refractive error. Background Community-based eye health screenings and optometric exams were conducted in the NYC-SIGHT Study. Methods A sub-analysis of vision impairment and refractive error results within a 5-year prospective, cluster-randomised clinical trial. Eligible individuals (age ≥40 years) were recruited from 10 affordable housing developments in Upper Manhattan. Developments were randomised into usual care (received glasses prescription only) and intervention (free glasses) groups. Participants with 6/12 visual acuity or worse, intraocular pressure 23–29 mmHg, or an unreadable fundus image were scheduled with the study optometrist for refraction and a non-dilated exam. Visual improvement data were obtained by comparing the presenting acuity at screening compared to the best corrected acuity after refraction by the optometrist. Chi-square, two-sample t-tests, and a stepwise multivariate logistic regression model were used to determined factors associated with improvable visual impairment. Results Seven hundred and eight participants completed screening, 308 received an optometric exam. Those with improvable vision impairment (n = 251), mean age: 69.8 years, 70.5% female, 53% African American, 39.8% Hispanic, >95% had health insurance. Refractive error diagnosed in 87.8% of the participants; lines of improvement: 2 lines (n = 59), 3 to 5 lines (n = 120), and ≥6 lines (n = 72). Stepwise multivariate logistic regression analysis showed that participants with visual acuity 6/12 or worse (odds ratio 16.041, 95% confidence interval 6.009 to 42.822, p = 0.000) or a normal fundus image (odds ratio 2.783, 95% confidence interval 1.001 to 7.740, p = 0.05) had significantly higher odds of improvable vision impairment. Conclusion This innovative, targeted community-based study included an optometrist who detected high rates of refractive error and improvable vision impairment in an underserved population living in New York City.

Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence

Dental caries is the world's most prevalent noncommunicable disease and a source of health inequity; school dental sealant programs are a common preventive measure. Silver diamine fluoride (SDF) may provide an alternative therapy to prevent and control caries if shown to be noninferior to sealant treatment. To determine whether school-based application of SDF is noninferior to dental sealants and atraumatic restorative treatment (ART) in the prevalence of dental caries. The Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-Income Minority Children (CariedAway) study was a pragmatic noninferiority cluster-randomized clinical trial conducted from February 2018 to June 2023 to compare silver diamine fluoride vs therapeutic sealants for the arrest and prevention of dental caries. Children at primary schools in New York, New York, with at least 50% of the student population reporting as Black or Hispanic and at least 80% receiving free or reduced lunch were included. This population was selected as they are at the highest risk of caries in New York. Students were randomized to receive either SDF or sealant with ART; those aged 5 to 13 years were included in the analysis. Treatment was provided at every visit based on need, and the number of visits varied by child. Schools with preexisting oral health programs were excluded, as were children who did not speak English. Of 17 741 students assessed for eligibility, 7418 were randomized, and 4100 completed follow-up and were included in the final analysis. Participants were randomized at the school level to receive either a 38% concentration SDF solution or glass ionomer sealants and ART. Each participant also received fluoride varnish. Primary study outcomes were the prevalence and incidence of dental caries. A total of 7418 children (mean [SD] age, 7.58 [1.90] years; 4006 [54.0%] female; 125 [1.7%] Asian, 1246 [16.8%] Black, 3648 [49.2%] Hispanic, 153 [2.1%] White, 114 [1.5%] multiple races or ethnicities, 90 [1.2%] other [unspecified], 2042 [27.5%] unreported) were enrolled and randomized to receive either SDF (n = 3739) or sealants with ART (n = 3679). After initial treatment, 4100 participants (55.0%) completed at least 1 follow-up observation. The overall baseline prevalence of dental caries was approximately 27.2% (95% CI, 25.7-28.6). The odds of decay prevalence decreased longitudinally (odds ratio [OR], 0.79; 95% CI, 0.75-0.83) and SDF was noninferior compared to sealants and ART (OR, 0.94; 95% CI, 0.80-1.11). The crude incidence of dental caries in children treated with SDF was 10.2 per 1000 tooth-years vs 9.8 per 1000 tooth-years in children treated with sealants and ART (rate ratio, 1.05; 95% CI, 0.97-1.12). In this school-based pragmatic randomized clinical trial, application of SDF resulted in nearly identical caries incidence compared to dental sealants and ART and was noninferior in the longitudinal prevalence of caries. These findings suggest that SDF may provide an effective alternative for use in school caries prevention. ClinicalTrials.gov Identifier: NCT03442309.

Adoption of New Oral Health Interventions in Primary Care: Qualitative Findings

Introduction: This is the first study to use the Common-Sense Model of Self-Regulation (CSM) theory for oral health (OH) interventions in pediatric practices. The objective of this qualitative study was to assess adoption and implementation of theory-based multi-level OH interventions, by clinicians (pediatricians and nurse practitioners) participating in a cluster-randomized clinical trial (cRCT), to create an OH toolkit for widespread dissemination into pediatric practices. Methods: Semi-structured interviews were conducted at the conclusion of the cRCT with 21 clinicians from 9 practices participating in the intervention arm. Clinicians in this arm received CSM theory-based education and resources to deliver OH interventions to parents/caregivers and document in EMR. Semi-structured interview questions were based on the Diffusion of Innovations Theory, assessing adoption and implementation. The interviews were coded using NVivo (QRS International) software. Main themes were identified using a thematic analysis approach. Results: Five themes identified from the interviews included: strengths of theory-based OH training for clinicians, OH resources to improve quality of care, considerations for efficient future implementation, financial considerations, and parent benefits and challenges. Clinicians found that the theory-based training and resources increased knowledge and confidence when addressing OH with parents and required only ≤ 2 minutes in their workflow with no financial consequences. Clinicians reported an increase in OH awareness among parents but suggested an overall need for more pediatric dentists. Conclusions: The CSM theory-based education and resources were well received by clinicians and perceived to be beneficial without adverse impact on workflow or practice finances. An online toolkit is planned, as these OH interventions can be successfully implemented and delivered in medical settings.

Healthcare Professionals' Perceptions about the Implementation of Shared Decision-Making in Primary Care: A Qualitative Study from a Virtual Community of Practice.

The incorporation of shared decision making (SDM) is a central part of empowerment processes, as it facilitates greater activation on the part of patients, increasing the likelihood of them gaining control over their healthcare and developing skills to solve their health problems. Despite these benefits, there are still difficulties in the implementation of SDM among healthcare professionals due to internal and external factors related to the context and health systems. To explore primary care professionals (PCPs)' perceptions of the SDM model, based on their preconceptions and experience in clinical practice. A framework analysis was conducted on qualitative data derived from a virtual community practice forum, within a cluster-randomized clinical trial developed in the e-MPODERA project. The most important points in the opinions of the PCPs were: exploring the patients' values, preferences and expectations, providing them with and checking their understanding of up-to-date and evidence-based health information. The analysis revealed three themes: determinants of the implementation process of SDM, lack of consistency and dilemmas and benefits of PCP active listening, motivation and positive expectations of SDM. In our initial analysis, we examined the connections between the categories of the TDC model and its application in the primary care context. The categories related to the model reflect the theoretical understanding of professionals, while those related to perceptions of its application and use show certain discrepancies. These discrepancies could indicate a lack of understanding of the model and its real-world implications or insufficient commitment on the part of professionals or the organization to ensure its effective implementation. Specific targeted training that addresses knowledge, attitudes and practice may resolve the aforementioned findings.

An app-based training for adolescents with problematic digital-media use and their parents (Res@t digital): protocol for a cluster-randomized clinical trial.

Digital media-use disorders (DMUD) in adolescents are a rising phenomenon associated with psychological distress, comorbid mental disorders, and high burden on affected families. Since the ICD-11 introduced criteria for gaming disorder, these can now be transferred to describe additional DMUD associated with social media platforms and streaming services. Most evidence for effective treatments comes from cognitive-behavioral therapy (CBT). However, interventions based on theoretical models for adolescents and their parents are widely missing, leading to a significant clinical gap. Res@t digital (Resource-Strengthening Training for Adolescents with Problematic Digital-Media Use and their Parents) is the app-based translation of the first model-based digital intervention for adolescents with DMUD and their parents based on CBT. It comprises separate but content-related modules for adolescents (Res@t-A) and parents (Res@t-P), applying multimodal techniques. The effectiveness of Res@t will be evaluated within a multicenter cluster-randomized controlled evaluator-blinded pre-post follow-up trial with the waitlist control group (CG). In addition to the Res@t program in the intervention group, both groups will receive treatment as usual within primary child and adolescent psychiatric/psychotherapeutic healthcare. The primary outcome addresses DMUD symptom reduction after 10 weeks. Secondary outcomes are related to a reduction in psychological and family-related problems and an increase in parental self-efficacy. All outcomes will be assessed using standardized self-report measures. A total of 1,334 participating adolescent-parent dyads from a large clinical network throughout Germany are planned to be included in the primary analyses based on an intention-to-treat approach, applying linear mixed models. Assuming superiority of Res@t over the control condition, the intervention has the potential to provide evidence-based treatment for a significant number of help-seeking families, supporting local healthcare structures and resources. It is a promising program for practicable implementation and flexible use in different settings. https://drks.de, DRKS00031043.

Enhanced exclusive enteral nutrition delivery during the first 7 days is associated with decreased 28-day mortality in critically ill patients with normal lactate level: a post hoc analysis of a multicenter randomized trial

Background and aimsExclusive enteral nutrition (EN) is often observed during the first week of ICU admission because of the extra costs and safety considerations for early parenteral nutrition. This study aimed to assess the association between nutrition intake and 28-day mortality in critically ill patients receiving exclusive EN.MethodsThis is a post hoc analysis of a cluster-randomized clinical trial that assesses the effect of implementing a feeding protocol on mortality in critically ill patients. Patients who stayed in the ICUs for at least 7 days and received exclusive EN were included in this analysis. Multivariable Cox hazard regression models and restricted cubic spline models were used to assess the relationship between the different doses of EN delivery and 28-day mortality. Subgroups with varying lactate levels at enrollment were additionally analyzed to address the potential confounding effect brought in by the presence of shock-related hypoperfusion.ResultsOverall, 1322 patients were included in the analysis. The median (interquartile range) daily energy and protein delivery during the first week of enrollment were 14.6 (10.3–19.6) kcal/kg and 0.6 (0.4–0.8) g/kg, respectively. An increase of 5 kcal/kg energy delivery was associated with a significant reduction (approximately 14%) in 28-day mortality (adjusted hazard ratio [HR] = 0.865, 95% confidence interval [CI]: 0.768–0.974, P = 0.016). For protein intake, a 0.2 g/kg increase was associated with a similar mortality reduction with an adjusted HR of 0.868 (95% CI 0.770–0.979). However, the benefits associated with enhanced nutrition delivery could be observed in patients with lactate concentration ≤ 2 mmol/L (adjusted HR = 0.804 (95% CI 0.674–0.960) for energy delivery and adjusted HR = 0.804 (95% CI 0.672–0.962) for protein delivery, respectively), but not in those > 2 mmol/L.ConclusionsDuring the first week of critical illness, enhanced nutrition delivery is associated with reduced mortality in critically ill patients receiving exclusive EN, only for those with lactate concentration ≤ 2 mmol/L.Trial registration: ISRCTN12233792, registered on November 24, 2017.

Relationship between HIV viral suppression and multidrug resistant tuberculosis treatment outcomes.

The impact of HIV viral suppression on multidrug resistant tuberculosis (MDR-TB) treatment outcomes among people with HIV (PWH) has not been clearly established. Using secondary data from a cluster-randomized clinical trial among people with MDR-TB in South Africa, we examined the effects of HIV viral suppression at MDR-TB treatment initiation and throughout treatment on MDR-TB outcomes among PWH using multinomial regression. This analysis included 1479 PWH. Viral suppression (457, 30.9%), detectable viral load (524, 35.4%), or unknown viral load (498, 33.7%) at MDR-TB treatment initiation were almost evenly distributed. Having a detectable HIV viral load at MDR-TB treatment initiation significantly increased risk of death compared to those virally suppressed (relative risk ratio [RRR] 2.12, 95% CI 1.11-4.07). Among 673 (45.5%) PWH with a known viral load at MDR-TB outcome, 194 (28.8%) maintained suppression, 267 (39.7%) became suppressed, 94 (14.0%) became detectable, and 118 (17.5%) were never suppressed. Those who became detectable (RRR 11.50, 95% CI 1.98-66.65) or were never suppressed (RRR 9.28, 95% CI 1.53-56.61) were at significantly increased risk of death (RRR 6.37, 95% CI 1.58-25.70), treatment failure (RRR 4.54, 95% CI 1.35-15.24), and loss to follow-up (RRR 7.00, 95% CI 2.83-17.31; RRR 2.97, 95% CI 1.02-8.61) compared to those who maintained viral suppression. Lack of viral suppression at MDR-TB treatment initiation and failure to achieve or maintain viral suppression during MDR-TB treatment drives differences in MDR-TB outcomes. Early intervention to support access and adherence to antiretroviral therapy among PWH should be prioritized to improve MDR-TB treatment outcomes.

Recruitment of older adults from long-term care settings for a longitudinal clinical trial.

Recruitment of residents for research from long-term care settings is known to be difficult. The purpose of this study was to summarize the effectiveness and cost in terms of time and dollars of recruitment methods for a cluster-randomized controlled clinical trial conducted in long-term care settings. This study was a retrospective, exploratory, descriptive analysis of recruitment data. After recruitment of 15 independent and assisted living communities, residents at each site were recruited to participate in the study using combinations of 12 different recruitment methods. Recruitment methods, time spent screening, and enrollment data were collected. Recruitment data were analyzed at the levels of site, research staff member, and participant. Over the study period, 279 older adults were screened and 172 enrolled from the 15 sites. Many participants were cognitively impaired. Research staff spent 39-89 h recruiting at each site and utilized an average of four different recruitment methods per site. Introductions of participants by site contacts yielded the most consented participants compared to other recruitment methods. Sites that had a dedicated recruiter utilized more recruiting methods and enrolled more participants than those without a dedicated recruiter. The cost of recruiting averaged $1490 per site and $93-$258 per enrollee (mean $144, standard deviation $58), but was more costly in larger facilities. Recruitment of older adults from long-term care communities requires multiple methods of recruitment, skilled recruitment staff, and trust with the staff and potential participants.

Predictors of improved clinician screening, assessment, and treatment for tobacco use for clients in community mental healthcare following training

IntroductionPeople with mental illness (MI) are more likely to smoke cigarettes and less likely to receive treatment for tobacco use than the general population. Understanding factors associated with improved staff treatment of tobacco use in community mental health settings has received limited study. MethodsWe used data from a completed cluster-randomized clinical trial that tested two interventions designed to increase treatment for tobacco use in mental health clinics. Among 222 clinic staff, we examined demographic and employment characteristics, changes in perceived skills, knowledge, and beliefs using the S-KAP (i.e., perceptions of staff responsibility to treat tobacco use; client quit motivation; client outcomes; and barriers) as predictors of change in clinician reported delivery of tobacco use treatment following training. ResultsClinician reported treatment of client tobacco use significantly increased from baseline to week 52 across both study arms (p<0.001). This increase in reported treatment for tobacco use was associated with increases from baseline to week 52 in clinician reported skills to treat tobacco use, perceptions of responsibility to treat client tobacco use, and perceptions about client motivation to quit smoking (p's<0.05). ConclusionsTraining clinicians in community mental healthcare to address client tobacco use may improve outcomes by helping them to develop the needed skills, convincing them that treating tobacco use is part of their role as clinicians, and by helping clinicians to recognize that clients are motivated to quit smoking. These may be targets to improve how clinicians in community health settings address client tobacco use.

Abstract 18766: Optimizing Stroke Prophylaxis in the Emergency Department With an Electronic Clinical Decision Support Tool: A Preliminary Analysis of a Multi-Stage Multi-Center Stepped-Wedge Cluster Randomized Trial

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia that is often first diagnosed in the Emergency Department (ED). AF is associated with an increased risk of stroke that can be reduced by 64% if an oral anticoagulant (OAC) is prescribed appropriately. RESEARCH QUESTION: Will education and implementation of a clinical decision support (CDS) tool in the ED increase OAC prescription for appropriate candidates diagnosed with new-onset or paroxysmal AF (pAF)? METHODS: This is the first phase of a multi-stage multi-center stepped-wedge cluster-randomized clinical trial implementing a CDS tool into the electronic health record (EHR). Step one implements an external browser link to the CDS tool in the EHR with targeted provider education, whereas steps 2 and 3 will motivate provider engagement with triggers. Data were collected from an urban academic tertiary care center and a community hospital. Patients aged greater than 17 years were selected if they had a primary diagnosis of AF/pAF during ED visits from Jan 2020-Apr 2023. The academic and community sites transitioned from the retrospective phase to Step 1 in Jan 2022 and Apr 2022, respectively. Appropriate OAC prescription was determined based on elevated stroke risk and low-moderate bleed risk. A logistic GEE model was used to study the effect of the proposed intervention on OAC prescription. ED providers were treated as a random effect to capture clustering. The model includes the CDS intervention, site, and patient characteristics sex, race, ethnicity, and age. RESULTS: Of 2031 patients, 312 met inclusion criteria and 150 were selected as appropriate OAC candidates, with 72 (52% male, median age 74) in the retrospective step and 78 (52% male, median age 76) in Step 1. Below are odds ratio estimates with corresponding 95% CI’s: CDS intervention 3.12 [1.57, 6.21] and sex female vs male 2.04 [1.04, 4.00]. Non-significant variables site, race, ethnicity, and age were included as adjusting covariates. CONCLUSIONS: Limited CDS tool education and integration is associated with improved OAC prescribing for appropriate AF/pAF patients. Future studies should assess the impact of additional CDS integration on OAC prescribing and patient outcomes.

Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation

ImportancePatients with advanced chronic kidney disease (CKD) have the best chance for a longer and healthier life if they receive a kidney transplant. However, many barriers prevent patients from receiving a transplant.ObjectivesTo evaluate the effect of a multicomponent intervention designed to target several barriers that prevent eligible patients from completing key steps toward receiving a kidney transplant.Design, Setting, and ParticipantsThis pragmatic, 2-arm, parallel-group, open-label, registry-based, superiority, cluster randomized clinical trial included all 26 CKD programs in Ontario, Canada, from November 1, 2017, to December 31, 2021. These programs provide care for patients with advanced CKD (patients approaching the need for dialysis or receiving maintenance dialysis).InterventionsUsing stratified, covariate-constrained randomization, allocation of the CKD programs at a 1:1 ratio was used to compare the multicomponent intervention vs usual care for 4.2 years. The intervention had 4 main components, (1) administrative support to establish local quality improvement teams; (2) transplant educational resources; (3) an initiative for transplant recipients and living donors to share stories and experiences; and (4) program-level performance reports and oversight by administrative leaders.Main Outcomes and MeasuresThe primary outcome was the rate of steps completed toward receiving a kidney transplant. Each patient could complete up to 4 steps: step 1, referred to a transplant center for evaluation; step 2, had a potential living donor contact a transplant center for evaluation; step 3, added to the deceased donor waitlist; and step 4, received a transplant from a living or deceased donor.ResultsThe 26 CKD programs (13 intervention, 13 usual care) during the trial period included 20 375 potentially transplant-eligible patients with advanced CKD (intervention group [n = 9780 patients], usual-care group [n = 10 595 patients]). Despite evidence of intervention uptake, the step completion rate did not significantly differ between the intervention vs usual-care groups: 5334 vs 5638 steps; 24.8 vs 24.1 steps per 100 patient-years; adjusted hazard ratio, 1.00 (95% CI, 0.87-1.15).Conclusions and RelevanceThis novel multicomponent intervention did not significantly increase the rate of completed steps toward receiving a kidney transplant. Improving access to transplantation remains a global priority that requires substantial effort.Trial RegistrationClinicalTrials.gov Identifier: NCT03329521

Evaluating risk of bias using ROBINS-I tool in nonrandomized studies of adjuvanted influenza vaccine

Seasonal variation in influenza vaccine effectiveness (VE) makes real-world evidence (RWE) useful in supplementing the clinical-evidence base from randomized clinical trials. Adjuvanted inactivated influenza vaccine (aIIV) VE has been evaluated in multiple nonrandomized RWE studies. A systematic literature review of RWE studies evaluating the absolute or relative VE of aIIV was conducted. Identified studies were assessed by evaluators for risk of bias (RoB) by means of the ROBINS-I (Reduction of Bias In Non-randomized Studies of Interventions) tool to inform evidence-based medicine deliberations. Differences in evaluator assessments were resolved by consensus. The literature review yielded 14 follow-up studies, seven test-negative case-control (TNCC) studies, five traditional case-control studies, and one cluster-randomized clinical trial. Most follow-up studies and three TNCC studies were judged at low RoB. Issues increasing RoB included inadequate control of confounding, selection of controls, and reliance on recall of vaccination. The concerns identified in any of the designs could be mitigated with straightforward revisions to design or implementation. 17 of 27 nonrandomized studies of adjuvanted influenza-vaccine effectiveness, some from each of four study designs, were judged at low risk of material bias. These studies merit credence in assessing aIIV effectiveness relative to other influenza vaccines.

Personalized Multilevel Intervention for Improving Appropriate Use of Colorectal Cancer Screening in Older Adults

Despite guideline recommendations, clinicians do not systematically use prior screening or health history to guide colorectal cancer (CRC) screening decisions in older adults. To evaluate the effect of a personalized multilevel intervention on screening orders in older adults due for average-risk CRC screening. Interventional 2-group parallel unmasked cluster randomized clinical trial conducted from November 2015 to February 2019 at 2 US Department of Veterans Affairs (VA) facilities: 1 academic VA medical center and 1 of its connected outpatient clinics. Randomization at the primary care physician/clinician (PCP) level, stratified by study site and clinical full-time equivalency. Participants were 431 average-risk, screen-due US veterans aged 70 to 75 years attending a primary care visit. Data analysis was performed from August 2018 to August 2023. The intervention group received a multilevel intervention including a decision-aid booklet with detailed information on screening benefits and harms, personalized for each participant based on age, sex, prior screening, and comorbidity. The control group received a multilevel intervention including a screening informational booklet. All participants received PCP education and system-level modifications to support personalized screening. The primary outcome was whether screening was ordered within 2 weeks of clinic visit. Secondary outcomes were concordance between screening orders and screening benefit and screening utilization within 6 months. A total of 436 patients were consented, and 431 were analyzed across 67 PCPs. Patients had a mean (SD) age of 71.5 (1.7) years; 424 were male (98.4%); 374 were White (86.8%); 89 were college graduates (21.5%); and 351 (81.4%) had undergone prior screening. A total of 258 (59.9%) were randomized to intervention, and 173 (40.1%) to control. Screening orders were placed for 162 of 258 intervention patients (62.8%) vs 114 of 173 control patients (65.9%) (adjusted difference, -4.0 percentage points [pp]; 95% CI, -15.4 to 7.4 pp). In a prespecified interaction analysis, the proportion receiving orders was lower in the intervention group than in the control group for those in the lowest benefit quartile (59.4% vs 71.1%). In contrast, the proportion receiving orders was higher in the intervention group than in the control group for those in the highest benefit quartile (67.6% vs 52.2%) (interaction P = .049). Fewer intervention patients (106 of 256 [41.4%]) utilized screening overall at 6 months than controls (96 of 173 [55.9%]) (adjusted difference, -13.4 pp; 95% CI, -25.3 to -1.6 pp). In this cluster randomized clinical trial, patients who were presented with personalized information about screening benefits and harms in the context of a multilevel intervention were more likely to receive screening orders concordant with benefit and were less likely to utilize screening. ClinicalTrials.gov Identifier: NCT02027545.

Direct Gloving vs Hand Hygiene Before Donning Gloves in Adherence to Hospital Infection Control Practices

Current guidelines require hand hygiene before donning nonsterile gloves, but evidence to support this requirement is lacking. To evaluate the effectiveness of a direct-gloving policy on adherence to infection prevention practices in a hospital setting. This mixed-method, multicenter, cluster randomized clinical trial was conducted at 4 academic centers in Baltimore, Maryland, or Iowa City, Iowa, from January 1, 2016, to November 30, 2017. Data analysis was completed April 25, 2019. Participants were 3790 health care personnel (HCP) across 13 hospital units. Hospital units were randomly assigned to direct gloving, with hand hygiene not required before donning gloves (intervention), or to usual care (hand hygiene before donning nonsterile gloves). The primary outcome was adherence to the expected practice at room entry and exit. A random sample of HCPs' gloved hands were imprinted on agar plates at entry to contact precautions rooms. The intention-to-treat approach was followed, and all analyses were conducted at the level of the participating unit. Primary and secondary outcomes between treatment groups were assessed using generalized estimating equations with an unstructured working correlation matrix to adjust for clustering; multivariate analysis using generalized estimating equations was conducted to adjust for covariates, including baseline adherence. In total, 13 hospital units participated in the trial, and 3790 HCP were observed. Adherence to expected practice was greater in the 6 units with the direct-gloving intervention than in the 7 usual care units (1297 of 1491 [87%] vs 954 of 2299 [41%]; P < .001) even when controlling for baseline hand hygiene rates, unit type, and universal gloving policies (risk ratio [RR], 1.76; 95% CI, 1.58-1.97). Glove use on entry to contact precautions rooms was also higher in the direct-gloving units (1297 of 1491 [87%] vs 1530 of 2299 [67%]; P = .008. The intervention had no effect on hand hygiene adherence measured at entry to non-contact precautions rooms (951 of 1315 [72%] for usual care vs 1111 of 1688 [66%] for direct gloving; RR, 1.00 [95% CI, 0.91-1.10]) or at room exit (1587 of 1897 [84%] for usual care vs 1525 of 1785 [85%] for direct gloving; RR, 0.98 [95% CI, 0.91-1.07]). The intervention was associated with increased total bacteria colony counts (adjusted incidence RR, 7.13; 95% CI, 3.95-12.85) and greater detection of pathogenic bacteria (adjusted incidence RR, 10.18; 95% CI, 2.13-44.94) on gloves in the emergency department and reduced colony counts in pediatrics units (adjusted incidence RR, 0.34; 95% CI, 0.19-0.63), with no change in either total colony count (RR, 0.87 [95% CI, 0.60 to 1.25] for adult intensive care unit; RR, 0.59 [95% CI, 0.31-1.10] for hemodialysis unit) or presence of pathogenic bacteria (RR, 0.93 [95% CI, 0.40-2.14] for adult intensive care unit; RR, 0.55 [95% CI, 0.15-2.04] for hemodialysis unit) in the other units. Current guidelines require hand hygiene before donning nonsterile gloves, but evidence to support this requirement is lacking. The findings from this cluster randomized clinical trial indicate that a direct-gloving strategy without prior hand hygiene should be considered by health care facilities. ClinicalTrials.gov Identifier: NCT03119389.