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Background: This study is a cost-effectiveness study of two implementation strategies designed to train therapists in college and university counseling centers to deliver interpersonal psychotherapy. Costs of implementing a train-the-trainer (TTT) strategy versus an expert consultation strategy were estimated, and their relative effects upon therapist outcomes were calculated and compared. Methods: Twenty four counseling centers were recruited across the United States. These centers were randomized to either a TTT (experimental) condition, in which an in-house therapist trained other center therapists, or an expert consultation condition, in which center therapists participated in a workshop and received 12 months of ongoing supervision. The main outcome was therapist fidelity (adherence and competence) to interpersonal psychotherapy, assessed via audio recordings of therapy sessions, and analyzed using linear mixed models. Costs of each condition were quantified using time-driven activity-based costing methods, and involved a costing survey administered to center directors, follow up interviews and validation checks, and comparison of time tracking logs of trainers in the expert condition. Mean costs to produce one therapist were obtained for each condition. The costs to produce equivalent improvements in therapist-level outcomes were then compared between the two conditions. Results: Mean cost incurred by counseling centers to train one therapist using the TTT strategy was $3,407 (median = $3,077); mean cost to produce one trained therapist in the control condition was $2,055 (median = $1,932). Therapists in the TTT condition, on average, demonstrated a 0.043 higher adherence score compared to therapists in the control condition; however, this difference was not statistically significant. For the competence outcome, effect size for therapists in the TTT condition was in the large range (1.16; 95% CI: 0.85–1.46; p <.001), and therapists in this condition, on average, demonstrated a 0.073 higher competence score compared to those in the expert consultation condition (95% CI, 0.008–0.14; p =.03). Counseling centers that used the TTT model incurred $353 less in training costs to produce equivalent improvements in therapist competence. Conclusions: Despite its higher short run costs, the TTT implementation strategy produces greater increases in therapist competence when compared to expert consultation. Expanding resources to support this platform for service delivery can be an effective way to enhance the mental health care of young people seeking care in college and university counseling centers. Trial registration: ClinicalTrials.gov Identifier: NCT02079142. [ABSTRACT FROM AUTHOR]

Background: Black individuals in the United States (US) have a higher incidence of and mortality from colorectal cancer (CRC) compared to other racial groups, and CRC is the second leading cause of death among Hispanic/Latino populations in the US. Patient navigation is an evidence-based approach to narrow inequities in cancer screening among Black and Hispanic/Latino patients. Despite this, limited healthcare systems have implemented patient navigation for screening at scale. Methods: We are conducting a stepped-wedge cluster randomized trial of 15 primary care clinics with six steps of six-month duration to scale a patient navigation program to improve screening rates among Black and Hispanic/Latino patients. After six months of baseline data collection with no intervention we will randomize clinics, whereby three clinics will join the intervention arm every six months until all clinics cross over to intervention. During the intervention roll out we will conduct training and education for clinics, change infrastructure in the electronic health record, create stakeholder relationships, assess readiness, and deliver iterative feedback. Framed by the Practical, Robust Implementation Sustainment Model (PRISM) we will focus on effectiveness, reach, provider adoption, and implementation. We will document adaptations to both the patient navigation intervention and to implementation strategies. To address health equity, we will engage multilevel stakeholder voices through interviews and a community advisory board to plan, deliver, adapt, measure, and disseminate study progress. Provider-level feedback will include updates on disparities in screening orders and completions. Discussion: Primary care clinics are poised to close disparity gaps in CRC screening completion but may lack an understanding of the magnitude of these gaps and how to address them. We aim to understand how to tailor a patient navigation program for CRC screening to patients and providers across diverse clinics with wide variation in baseline screening rates, payor mix, proximity to specialty care, and patient volume. Findings from this study will inform other primary care practices and health systems on effective and sustainable strategies to deliver patient navigation for CRC screening among racial and ethnic minorities. Trial registration: NCT06401174 [ABSTRACT FROM AUTHOR]

Background: HIV disproportionately affects Black/African American cisgender women (hereafter women) in the United States. Despite its proven effectiveness, pre-exposure prophylaxis (PrEP) for HIV prevention remains vastly under-prescribed to women based on their need. Increasing PrEP uptake and persistence among women is crucial to reducing HIV transmission; however, there have been few studies designed specifically for women. This article describes the study protocol used to assess the feasibility, acceptability, and effectiveness of implementation strategies to improve PrEP uptake and persistence among Black women in the Midwest and South. Methods: PrEP Optimization among Women to Enhance Retention and Uptake (POWER Up) is an evidence-based, woman-focused set of five implementation science strategies that addresses barriers of PrEP utilization at the provider, patient, and clinic levels. POWER Up includes 1) routine PrEP education for patients, 2) standardized provider training, 3) electronic medical record (EMR) optimization, 4) PrEP navigation, and 5) PrEP clinical champions. These strategies will be adapted to specific clinics for implementation, tested via a stepped-wedge trial, and, if effective, packaged for further dissemination. Discussion: We will utilize a stepped-wedge cluster randomized trial (SW-CRT) to measure change in PrEP utilization across diverse geographic areas. Preparation for adapting and implementing the bundle of strategies is needed to determine how to tailor them to specific clinics. Implementation challenges will include adapting strategies with the available resources at each site, maintaining stakeholder involvement and staff buy-in, adjusting the study protocol and planned procedures as needed, and ensuring minimal crossover. Additionally, strengths and limitations of each strategy must be examined before, during, and after the adaptation and implementation processes. Finally, the implementation outcomes of the strategies must be evaluated to determine the real-world success of the strategies. This study is an important step toward addressing the inequity in PrEP service delivery and increasing PrEP utilization among Black women in the U.S. [ABSTRACT FROM AUTHOR]

Objective: The Student Bodies-Eating Disorders intervention (SB-ED), a digital cognitive behavior therapy-guided self-help intervention for college women with an eating disorder, is effective for reducing eating disorder psychopathology. The purpose of this study was to evaluate moderators and mediators of the SB-ED intervention. To our knowledge, this is the first evaluation of clinical mediators of a digital intervention for women with eating disorders. Method: This is an exploratory secondary analysis of a cluster randomized trial comparing the SB-ED intervention to referral to usual care among 690 women at 27 United States colleges. Moderators included body mass index (BMI), race, ethnicity, weight/shape concerns, eating disorder impairment, thin ideal internalization, depression, anxiety, and motivation for treatment, assessed at baseline. Thin ideal internalization and depressive symptoms were tested as predictors at postintervention and mediators at 2-year follow-up. Outcome was change in global eating disorder psychopathology. Results: BMI moderated the effect of the intervention at follow-up (but not posttreatment), with individuals with a lower BMI experiencing more continued improvements in eating disorder psychopathology following the intervention than individuals with a higher BMI. Thin ideal internalization mediated the effect of the intervention at follow-up, and depression partially mediated the effect of the intervention at follow-up. Conclusions: Results of the mediator analyses suggest that helping college women reduce inflated internalization of the thin ideal and improve depressive symptoms leads to improvements in eating disorder psychopathology. Results also suggest opportunities to optimize the intervention so individuals across the BMI spectrum experience ongoing improvements over time. What is the public health significance of this article?: The digital guided self-help Student Bodies-Eating Disorders intervention reduces women's thin ideal internalization and depressive symptoms, which in turn leads to improvements in eating disorder psychopathology. Women with higher body mass index (BMIs) experienced less continued improvement following the intervention, indicating future directions for intervention optimization. [ABSTRACT FROM AUTHOR]

Objective: Despite the high prevalence of obesity and associated health risks in the United States adult population, few primary care providers (PCPs) have time and training to provide weight-management counseling to their patients. This study aims to compare the effect of referral to a comprehensive automated digital weight-loss program, with or without provider email feedback, with usual care on weight loss in patients with overweight or obesity.Methods: A total of 550 adults (mean [SD], 51.4 [11.2] years, BMI = 35.1 [5.5] kg/m2 , 72.0% female) were enrolled through their PCPs (n = 31). Providers were randomly assigned to refer their patients to a 12-month internet weight-loss intervention only (IWL), the intervention plus semiautomated feedback from the provider (IWL + PCP), or to usual care (EUC). Weight was measured at baseline and at 3, 6, and 12 months.Results: Weight changes (mean [SE]) at 12 months were -0.92 (0.46), -3.68 (0.46), and -3.58 (0.48) kg in the EUC, IWL, and IWL + PCP groups, respectively. Outcomes were significantly different in EUC versus IWL and EUC versus IWL + PCP (p < 0.001), but not in IWL versus IWL + PCP.Conclusions: Referral by PCPs to an automated weight-loss program holds promise for patients with obesity. Future research should explore ways to further promote accountability and adherence. [ABSTRACT FROM AUTHOR]

Background: For people living with dementia (PLWD) the overuse of potentially inappropriate medications (PIMs) remains a persistent problem. De-prescribing trials in the elderly have mixed results. Clinician champions may be uniquely suited to lead efforts to address this challenge. Here we describe the study protocol for a 24-month embedded pragmatic cluster-randomized clinical trial within two accountable care organizations (ACOs) of such a clinician champion intervention. The specific aims are to (1) assess the effectiveness of a clinician champion on de-implementing PIMs in PLWD, (2) determine if the intervention is associated with a reduction in emergency department (ED) visits and hospitalizations attributed to a fall, and (3) examine five implementation outcomes: appropriateness, feasibility, fidelity, penetration, and equity.Methods/design: Two ACOs agreed to participate: United States Medical Management (USMM) and Oschner Health System. The unit of randomization will be the primary care clinic. A clinician champion will be recruited from each of the intervention clinics to participate in a 6-month training program and then work with clinicians and staff in their clinic for 12 months to reduce the use of PIMs in their PLWD population. For aims 1 and 2, Medicare claims data will be used to assess outcomes. The outcome for aim #1 will be medication possession rates per quarter, for the three therapeutic classes of PIMs among patients with dementia in intervention clinics versus control clinics. For aim #2, we will assess the incidence of falls using a previously validated algorithm. For both aims 1 and 2, we will construct hierarchical models with time period observations nested within patient using generalized estimating equations (GEE) with robust standard errors. The key variable of interest will be the treatment indicator assigned based on practice. For aim #3, we will conduct qualitative thematic analysis of documentation by the clinician champions in their project workbooks to evaluate the five implementation outcomes.Discussion: This embedded pragmatic trial will add to our existing knowledge regarding the effectiveness of a clinician champion strategy to de-prescribe potentially inappropriate medication among patients with dementia as well as its appropriateness, feasibility, fidelity, penetration, and equity.Trial Registration: Clinicaltrials.gov NCT05359679 , Registered May 4, 2022. [ABSTRACT FROM AUTHOR]

High teacher turnover rates and shortages of quality teachers plague many large, urban U.S. school districts disadvantaging their students who often already come from traditionally underserved populations and communities. Restorative Practices is a quickly growing whole school approach to community building and discipline, but little is known about how it impacts teachers and their career decisions. This study specifically investigates whether assignment to Restorative Practices (in combination with Diplomas Now, RP w/DN) improves school climate and increases teachers' reported intentions to remain at their school? To answer this question, we analyzed data from a multi-site, cluster randomized control trial of in 25 schools from seven large cities across the United States. Our intent-to-treat analyses find that RP w/DN has a significantly positive effect on school climate (ES =.15,.27). Impacts on teachers' turnover intentions were non-significant, but it significantly reduced perceptions of problematic teacher absenteeism (a related, exploratory outcome). Overall, the findings from this study suggest that Restorative Practices as a policy can improve school climate, but its relationship with teachers' career decisions is more complicated. [ABSTRACT FROM AUTHOR]

Objectives: Our objective was to assess the effects of mental health interventions for children, adolescents, and adults not quarantined or undergoing treatment due to COVID-19 infection.Methods: We searched 9 databases (2 Chinese-language) from December 31, 2019, to March 22, 2021. We included randomised controlled trials of interventions to address COVID-19 mental health challenges among people not hospitalised or quarantined due to COVID-19 infection. We synthesized results descriptively due to substantial heterogeneity of populations and interventions and risk of bias concerns.Results: We identified 9 eligible trials, including 3 well-conducted, well-reported trials that tested interventions designed specifically for COVID-19 mental health challenges, plus 6 other trials with high risk of bias and reporting concerns, all of which tested standard interventions (e.g., individual or group therapy, expressive writing, mindfulness recordings) minimally adapted or not specifically adapted for COVID-19. Among the 3 well-conducted and reported trials, 1 (N  =  670) found that a self-guided, internet-based cognitive-behavioural intervention targeting dysfunctional COVID-19 worry significantly reduced COVID-19 anxiety (standardized mean difference [SMD] 0.74, 95% confidence interval [CI], 0.58 to 0.90) and depression symptoms (SMD 0.38, 95% CI, 0.22 to 0.55) in Swedish general population participants. A lay-delivered telephone intervention for homebound older adults in the United States (N  =  240) and a peer-moderated education and support intervention for people with a rare autoimmune condition from 12 countries (N  =  172) significantly improved anxiety (SMD 0.35, 95% CI, 0.09 to 0.60; SMD 0.31, 95% CI, 0.03 to 0.58) and depressive symptoms (SMD 0.31, 95% CI, 0.05 to 0.56; SMD 0.31, 95% CI, 0.07 to 0.55) 6-week post-intervention, but these were not significant immediately post-intervention. No trials in children or adolescents were identified.Conclusions: Interventions that adapt evidence-based strategies for feasible delivery may be effective to address mental health in COVID-19. More well-conducted trials, including for children and adolescents, are needed. [ABSTRACT FROM AUTHOR]

Background: Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation.Methods: We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree.Results: Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003).Conclusions: The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology. [ABSTRACT FROM AUTHOR]

Background: Central line-associated bloodstream infections (CLABSIs) result in approximately 28,000 deaths and approximately $2.3 billion in added costs to the U.S. healthcare system each year, and yet, many of these infections are preventable. At two large health systems in the southeast United States, CLABSIs continue to be an area of opportunity. Despite strong evidence for interventions to prevent CLABSI and reduce associated patient harm, such as use of chlorhexidine gluconate (CHG) bathing, the adoption of these interventions in practice is poor. The primary objective of this study was to assess the effect of a tailored, multifaceted implementation program on nursing staff's compliance with the CHG bathing process and electronic health record (EHR) documentation in critically ill patients. The secondary objectives were to examine the (1) moderating effect of unit characteristics and cultural context, (2) intervention effect on nursing staff's knowledge and perceptions of CHG bathing, and (3) intervention effect on CLABSI rates.Methods: A stepped wedged cluster-randomized design was used with units clustered into 4 sequences; each sequence consecutively began the intervention over the course of 4 months. The Grol and Wensing Model of Implementation helped guide selection of the implementation strategies, which included educational outreach visits and audit and feedback. Compliance with the appropriate CHG bathing process and daily CHG bathing documentation were assessed. Outcomes were assessed 12 months after the intervention to assess for sustainability.Results: Among the 14 clinical units participating, 8 were in a university hospital setting and 6 were in community hospital settings. CHG bathing process compliance and nursing staff's knowledge and perceptions of CHG bathing significantly improved after the intervention (p = .009, p = .002, and p = .01, respectively). CHG bathing documentation compliance and CLABSI rates did not significantly improve; however, there was a clinically significant 27.4% decrease in CLABSI rates.Conclusions: Using educational outreach visits and audit and feedback implementation strategies can improve adoption of evidence-based CHG bathing practices.Trial Registration: ClinicalTrials.gov, NCT03898115 , Registered 28 March 2019. [ABSTRACT FROM AUTHOR]

Background: Beginning in 2019, stepped-wedge designs (SWDs) were being used in the investigation of interventions to reduce opioid-related deaths in communities across the United States. However, these interventions are competing with external factors such as newly initiated public policies limiting opioid prescriptions, media awareness campaigns, and the COVID-19 pandemic. Furthermore, control communities may prematurely adopt components of the intervention as they become available. The presence of time-varying external factors that impact study outcomes is a well-known limitation of SWDs; common approaches to adjusting for them make use of a mixed effects modeling framework. However, these models have several shortcomings when external factors differentially impact intervention and control clusters.Methods: We discuss limitations of commonly used mixed effects models in the context of proposed SWDs to investigate interventions intended to reduce opioid-related mortality, and propose extensions of these models to address these limitations. We conduct an extensive simulation study of anticipated data from SWD trials targeting the current opioid epidemic in order to examine the performance of these models in the presence of external factors. We consider confounding by time, premature adoption of intervention components, and time-varying effect modification- in which external factors differentially impact intervention and control clusters.Results: In the presence of confounding by time, commonly used mixed effects models yield unbiased intervention effect estimates, but can have inflated Type 1 error and result in under coverage of confidence intervals. These models yield biased intervention effect estimates when premature intervention adoption or effect modification are present. In such scenarios, models incorporating fixed intervention-by-time interactions with an unstructured covariance for intervention-by-cluster-by-time random effects result in unbiased intervention effect estimates, reach nominal confidence interval coverage, and preserve Type 1 error.Conclusions: Mixed effects models can adjust for different combinations of external factors through correct specification of fixed and random time effects. Since model choice has considerable impact on validity of results and study power, careful consideration must be given to how these external factors impact study endpoints and what estimands are most appropriate in the presence of such factors. [ABSTRACT FROM AUTHOR]

Although psychological treatments benefit youth with chronic pain, treatment is not accessible in most communities. Digital health interventions offer promise for expanding access and reach to this population. Using a stepped-wedge cluster randomized trial design, we evaluated effectiveness and implementation of a digital health delivered psychological intervention for pediatric chronic pain. One hundred forty-three youth, aged 10 to 17 years, with chronic pain and a caregiver were recruited from 8 clinics in the United States. Active intervention included access to the Web-based Management of Adolescent Pain (WebMAP) Mobile app and the WebMAP parent web site to learn pain self-management skills. Effectiveness outcomes included pain intensity, disability, and patient global impression of change, while Reach, Adoption, Implementation, and Maintenance were implementation outcomes. Results showed that youth in both treatment conditions (WebMAP vs Usual Care) had similar changes over time in pain and disability. Youth in the WebMAP condition perceived greater improvement (patient global impression of change) at post-treatment and follow-up (d's = 0.54 and 0.44, P < 0.05) compared with youth receiving usual care. Use of the digital health intervention was modest and variable; approximately 30% of youth and parents completed treatment. Greater engagement (number of completed modules) was associated with significantly greater reductions in pain and disability from pre-treatment to follow-up (d's = -0.57 and -0.38, P < 0.05). Parents, youth, and providers found treatment acceptable; providers had positive attitudes and demonstrated referrals over a maintenance period. Further research is needed to understand how to enhance treatment engagement with digital health interventions and optimize implementation. [ABSTRACT FROM AUTHOR]

Objective: To test the impact of connecting physicians, pharmacists, and patients to address medication nonadherence, and to compare different physician choice architectures.Data Sources and Study Setting: The study was conducted with 90 physicians and 2602 of their patients on medications treating chronic illness.Study Design: In this cluster randomized controlled trial, physicians were randomly assigned to an arm where the physician receives notification of patient nonadherence derived from real-time claims data, an arm where they receive this information and a pharmacist may contact patients either by default or by physician choice, and a control group. The primary outcome was resolving nonadherence within 30 days. We also considered physician engagement outcomes including viewing information about nonadherence and utilizing a pharmacist.Data Collection: Physician engagement was constructed from metadata from the study website; adherence outcomes were constructed from medication claims.Principal Findings: We see no differences between the treatment arms and control for the primary adherence outcome. The pharmacist intervention was 42 percentage points (95% CI: 28 pp-56 pp) more likely when it was triggered by default.Conclusions: Access to a pharmacist and real-time nonadherence information did not improve patient adherence. Physician process of care was sensitive to choice architecture. [ABSTRACT FROM AUTHOR]

There are over five million people in the United States living with dementia. Most live at home and are cared for by family. These family caregivers often assume care responsibilities without education about the disease, skills training, or support, and in turn become at risk for depression, burden, and adverse health outcomes when compared to non-dementia caregivers. Despite over 200 caregiver interventions with proven benefits, many caregivers lack access to these programs. One approach to enhance access is to embed evidence-based caregiver support programs in existing community-based services for people with dementia such as adult day services (ADS). Here we describe the protocol for an embedded pragmatic trial designed to augment standard ADS known as ADS Plus. ADS Plus provides family caregivers with support via education, referrals, and problem-solving techniques over 12 months, and is delivered on-site by existing ADS staff. Embedding a program in ADS requires an understanding of outcomes and implementation processes in that specific context. Thus, we deploy a hybrid design involving a cluster randomized two-group trial to evaluate treatment effects on caregiver wellbeing, ADS utilization, as well as nursing home placement. We describe implementation practices in 30 to 50 geographically and racially/ethnically diverse participating sites. Clinical trial registration #: NCT02927821 [ABSTRACT FROM AUTHOR]

Low back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP. The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently. The TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT. Trial Registration: ClinicalTrials.gov NCT02647658 Registered Jan. 6, 2016. [ABSTRACT FROM AUTHOR]

The purpose of this study was to assess the combined effectiveness of a parenting intervention, Families Preparing the New Generation (FPNG), and a youth curriculum, keepin' it REAL (kiR), on substance use prevention for middle school students in a large urban metro area of the southwest USA. The study aimed to generate usable knowledge on what works in adolescent substance use prevention and how it works best-a combined parent and youth programming or parent-only programming. A total of 532 adolescents in the 7th grade from 19 participating middle schools were randomly assigned into three intervention conditions: parent-youth (PY), parent-only (PO), and comparison (C). This article focuses on the comparison between PY and PO in order to determine which intervention strategy works best to reduce adolescent substance use including alcohol, inhalant, cigarette, and marijuana uses. A generalized estimating equation (GEE) model examined the longitudinal data. The results for alcohol use show that PO yielded better results than PY and that PY outperformed C after 20 months. Further, PO showed a decreasing trajectory in any substance use over time since the implementation of the intervention. The effect sizes based on Cohen's h indicate small effects in any substance use and alcohol use for PO condition and smaller effects for the PY condition. These findings have implications for the design of future culturally specific parenting and youth prevention interventions with Latino families. [ABSTRACT FROM AUTHOR]

Objective: Despite treatment advances in other domains, inpatient psychiatric hospitalization rates for individuals with first-episode psychosis remain high. Even with early intervention services, a third or more of individuals are hospitalized over the first 2 years of treatment. Reducing hospitalization is desirable from the individual's perspective and for public health reasons because hospitalization costs are a major component of treatment costs.Methods: Univariate and multivariate baseline and time-varying covariate analyses were conducted to identify predictors of hospitalization in the Recovery After an Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, a 2-year cluster randomized trial for participants experiencing a first episode of psychosis who were outpatients at study entry. The trial compared an early intervention treatment model (NAVIGATE) with usual community care at 34 clinics across the United States.Results: RAISE-ETP enrolled 404 participants of whom 382 had one or more postbaseline assessments that included hospitalization data. Thirty-four percent of NAVIGATE and 37% of usual-care participants were hospitalized during the trial. Risk analyses revealed significant predictors of hospitalization to be the number of hospitalizations before study entry; duration of untreated psychosis; and time-varying days of substance misuse, presence of positive symptoms, and beliefs about the value of medication.Conclusions: These results indicate that hospital use may be decreased by reducing the duration of untreated psychosis and prior hospitalizations, minimizing residual symptoms, preventing substance misuse, and facilitating adherence to medication taking. Addressing these factors could enhance the impact of first-episode early intervention treatment models and also enhance outcomes of people with first-episode psychosis treated using other models. [ABSTRACT FROM AUTHOR]

Abstract Building healthy fruit and vegetable (FV) consumption habits early in life is critical for primary prevention. However, U.S. youth do not come close to meeting national recommendations for FV intake. School-lunch salad bars are one of the most heavily promoted ways to meet FV guidelines. Contrary to popular belief, no rigorous randomized trials have examined whether salad bars increase students' FV consumption. This paper describes the design and rationale of a federally funded trial to evaluate whether introducing salad bars in elementary, middle, and high schools affects students' FV consumption and waste during lunch. A cluster factorial randomized trial will test new salad bars against waitlist controls, with and without an additional marketing intervention (N = 36 schools, N = 6804 students: n = 12 elementary, n = 12 middle and n = 12 high schools). Objective plate waste measurements of individual student's selection of FVs, consumption, and waste will be conducted using digital scales. Primary aim includes comparing FV consumption in schools without salad bars to those with new salad bars by grade level. Secondary aims include: a) whether FV marketing impacts the success of salad bars for FV consumption; b) whether salad bars differentially result in more FV waste compared to traditional serving methods; c) cost-benefit of using salad bars for consumption over traditional serving methods. When complete, this study stands to be one of the most definitive on the effectiveness of salad bars and contextual factors impacting their success. Findings will provide evidence for how to best spend limited federal dollars to improve FV intake in schools. Trial registration: ClinicalTrials.gov Identifier: NCT03283033 (date of registration: 9/14/2017). [ABSTRACT FROM AUTHOR]

Background: Physical activity (PA) has demonstrated a decreased risk in various cancers and other chronic diseases; however, rural residents are less likely to attain recommended levels of PA compared to urban and suburban counterparts. Given rural residents make up 15% of the United States population, there is a need for novel approaches to increase PA among this population. The goal of the present study is to investigate the effectiveness of a multilevel intervention to increase PA rates among rural residents.Methods/design: Guided by an ecological framework, a group-randomized design will be used to evaluate the effects of a three-level intervention for increasing PA among adult residents residing in 6 rural communities (n = 600) along with 6 control communities (n = 600). The intervention includes components at the individual (short message service [SMS] text messages), interpersonal (social support in walking groups), and community levels (events at existing trails). Innovative methods to encourage participation will be employed as well as a focus on life priorities (family, recreation, hobbies) other than health. Aim 1 includes a literature review and key informant interviews to determine the local contexts for intervention adaptation. Aim 2 will employ a set of interventions at the individual, interpersonal, and community-levels to evaluate their impact on moderate-to-vigorous PA as measured by self-reported (telephone survey) and objectively assessed (accelerometry) measures. These data are supplemented by location based on Global Positioning System and community audits, which provide information on recreational amenities, programs/policies, and street segments.Discussion: This study is among the first of its kind to test a multilevel intervention in a rural setting, address life priorities that compliment health outcomes, and examine moderation between behavioral interventions and the natural environments where people are physically active. Our results will influence the field by enhancing the ability to scale-up innovative, PA interventions with the potential to reach high-risk, rural populations.Trial Registration: Clinical Trials NCT03683173 , September 25, 2018. [ABSTRACT FROM AUTHOR]

Objective: We conducted a cluster-randomized trial evaluating an intervention that trained Chinese-American primary care physicians to increase their Chinese patients' colorectal cancer (CRC) screening. Methods: Twenty-five physicians (13 randomized to the intervention arm and 12 to the control arm) and 479 of their patients (aged 50-75 and nonadherent to CRC screening guidelines) were enrolled. The intervention, guided by Social Cognitive Theory, included a communication guide and 2 in-office training sessions to enhance physicians' efficacy in communicating CRC screening with patients. Patients' CRC screening rates (trial outcome) and rating of physician communication before intervention and at 12-month follow-up were assessed. Intention- to-treat analysis for outcome evaluation was conducted. Results: Screening rates were slightly higher in the intervention vs. the control arm (24.4% vs. 17.7%, p = .24). In post hoc analyses, intervention arm patients who perceived better communication were more likely to be screened than those who did not (OR = 1.09, 95% CI: 1.03, 1.15). This relationship was not seen in the control arm. Conclusions: This physician-focused intervention had small, non-significant effects in increasing Chinese patients' CRC screening rates. Physician communication appeared to explain intervention efficacy. More intensive interventions are needed to enhance Chinese patients' CRC screening. [ABSTRACT FROM AUTHOR]

Background: Large-scale implementation of evidence-based psychotherapies (EBPs) such as cognitive processing therapy (CPT) for posttraumatic stress disorder can have a tremendous impact on mental and physical health, healthcare utilization, and quality of life. While many mental health systems (MHS) have invested heavily in programs to implement EBPs, few eligible patients receive EBPs in routine care settings, and clinicians do not appear to deliver the full treatment protocol to many of their patients. Emerging evidence suggests that when CPT and other EBPs are delivered at low levels of fidelity, clinical outcomes are negatively impacted. Thus, identifying strategies to improve and sustain the delivery of CPT and other EBPs is critical. Existing literature has suggested two competing strategies to promote sustainability. One emphasizes fidelity to the treatment protocol through ongoing consultation and fidelity monitoring. The other focuses on improving the fit and effectiveness of these treatments through appropriate adaptations to the treatment or the clinical setting through a process of data-driven, continuous quality improvement. Neither has been evaluated in terms of impact on sustained implementation.Methods: To compare these approaches on the key sustainability outcomes and provide initial guidance on sustainability strategies, we propose a cluster randomized trial with mental health clinics (n = 32) in three diverse MHSs that have implemented CPT. Cohorts of clinicians and clinical managers will participate in 1 year of a fidelity oriented learning collaborative or 1 year of a continuous quality improvement-oriented learning collaborative. Patient-level PTSD symptom change, CPT fidelity and adaptation, penetration, and clinics' capacity to deliver EBP will be examined. Survey and interview data will also be collected to investigate multilevel influences on the success of the two learning collaborative strategies. This research will be conducted by a team of investigators with expertise in CPT implementation, mixed method research strategies, quality improvement, and implementation science, with input from stakeholders in each participating MHS.Discussion: It will have broad implications for supporting ongoing delivery of EBPs in mental health and healthcare systems and settings. The resulting products have the potential to significantly improve efforts to ensure ongoing high quality implementation and consumer access to EBPs.Trial Registration: NCT02449421 . Registered 02/09/2015. [ABSTRACT FROM AUTHOR]

Peaceful acceptance has been associated with improved outcomes for cancer patients, including better adjustment to illness and quality of life. Having quality conversations about care with oncologists may facilitate acceptance of illness. We evaluated how older patients' perceived efficacy and satisfaction with care in patient-physician interaction is associated with acceptance of illness. We conducted a secondary analysis of a cluster randomized trial of a geriatric assessment intervention among 541 participants from 31 community oncology practice across the United States. We recruited patients aged>70 years with an advanced solid malignant tumor or lymphoma. Participants completed demographic and clinical information at enrollment, Perceived Efficacy in Patient-Physician Interactions (PEPPI; range [5-25)], and Peaceful Acceptance of the Illness (PEACE; assesses patient's sense of acceptance, calmness, and peace concerning their illness [5-20]) at baseline. They completed satisfaction with care (measured by the Health Care Climate Questionnaire, HCCQ; [0-20]) at follow-up via telephone team call (within 1 to 7 days after the baseline visit). We performed a linear regression analysis using total sum scores (higher = better) evaluating the associations of PEPPI and HCCQ with PEACE, controlling for intervention and demographic variables. Funded by PCORI 4639; UG1CA189961; T32CA102618; K24AG056589 Patients had a mean age of 76.6 (SD 5.2) years. The majority were White (89.1%), male (51.0%), with mean scores of 17.51 (2.51), 21.33 (3.48), and 17.48 (2.72) for PEACE, PEPPI, and HCCQ respectively. Linear regression demonstrated positive associations among patients' perceived efficacy (unstandardized B=.23 (SE.03), p<.001) and their satisfaction with patient-physician interaction (unstandardized B=.10 (SE.04), p<.05) with peaceful acceptance. Quality communication with oncologists demonstrated positive association with peaceful acceptance, suggesting that quality conversations about cancer care is associated with patients' reporting peaceful acceptance of their illness. This is clinically important for end-of-life decision-making and care. [ABSTRACT FROM AUTHOR]

Background: Stepped wedge designs have gained recognition as a method for rigorously assessing implementation of evidence-based quality improvement interventions (QIIs) across multiple healthcare sites. In theory, this design uses random assignment of sites to successive QII implementation start dates based on a timeline determined by evaluators. However, in practice, QII timing is often controlled more by site readiness. We propose an alternate version of the stepped wedge design that does not assume the randomized timing of implementation while retaining the method's analytic advantages and applying to a broader set of evaluations. To test the feasibility of a nonrandomized stepped wedge design, we developed simulated data on patient care experiences and on QII implementation that had the structures and features of the expected data from a planned QII. We then applied the design in anticipation of performing an actual QII evaluation. Methods: We used simulated data on 108,000 patients to model nonrandomized stepped wedge results from QII implementation across nine primary care sites over 12 quarters. The outcome we simulated was change in a single self-administered question on access to care used by Veterans Health Administration (VA), based in the United States, as part of its quarterly patient ratings of quality of care. Our main predictors were QII exposure and time. Based on study hypotheses, we assigned values of 4 to 11 % for improvement in access when sites were first exposed to implementation and 1 to 3 % improvement in each ensuing time period thereafter when sites continued with implementation. We included site-level (practice size) and respondent-level (gender, race/ethnicity) characteristics that might account for nonrandomized timing in site implementation of the QII. We analyzed the resulting data as a repeated cross-sectional model using HLM 7 with a three-level hierarchical data structure and an ordinal outcome. Levels in the data structure included patient ratings, timing of adoption of the QII, and primary care site. Results: We were able to demonstrate a statistically significant improvement in adoption of the QII, as postulated in our simulation. The linear time trend while sites were in the control state was not significant, also as expected in the real life scenario of the example QII. Conclusions: We concluded that the nonrandomized stepped wedge design was feasible within the parameters of our planned QII with its data structure and content. Our statistical approach may be applicable to similar evaluations. [ABSTRACT FROM AUTHOR]

Objectives. To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. Methods. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. Results. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. Conclusions. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention. [ABSTRACT FROM AUTHOR]

Objectives. To evaluate the effectiveness of Pono Choices, a culturally responsive adolescent pregnancy and sexually transmitted infection (STI) prevention program targeting middle school youths in Hawai'i. Methods. We conducted a cluster randomized controlled trial with the school as the unit of randomassignment over 3 semesters between 2012 and 2013.The sample consisted of 36middle schools and 2203 students. We administered student surveys to collect baseline outcomes, student demographic data, and outcomes at 12 months after baseline. Results. We found statistically significant effects for the knowledge assessment, which focused on basic understanding of adolescent pregnancy and STI prevention. The average percentage of correct responses was 73.6 for the treatment group and 60.4 for the control group (P < .001). We did not find statistically significant effects on behavioral outcomes (initiation of sexual activity or engagement in high-risk sexual behavior) or on other nonbehavioral outcomes (attitudes, skills, intentions). Conclusions. Pono Choices had a statistically significant impact on knowledge of adolescent pregnancy and STI prevention among middle school students at 12 months after baseline, though it did not lead to detectable changes in behavioral outcomes within the 1-year observation period. These results call for an exploration of longer-term outcomes to assess effects on knowledge retention and behavioral changes. [ABSTRACT FROM AUTHOR]

Objectives. To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. Methods. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. Results. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. Conclusions. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use. [ABSTRACT FROM AUTHOR]

Objectives. To test the effectiveness of Reducing the Risk, an evidence-based sexual health curriculum designed to help prevent adolescent pregnancy and sexually transmitted infections, on youth sexual behavior and intermediate outcomes thought to lead to these behaviors. Methods. Classes within schools in St. Louis, Missouri; Austin, Texas; and San Diego, California; were randomly assigned to receive Reducing the Risk or "business as usual." Youths completedWeb-based surveys at baseline (preintervention, August 2012-January 2014) and 12 months later (August 2013-January 2015). Intent-to-treat analyses were conducted across sites; we tested for differences in impacts between sites and other subgroups. Results. The program had no overall impact on sexual behaviors. However, at 1 site, program participants were significantly less likely to have engaged in recent sexual intercourse than were control group members. There were positive overall impacts on intermediate outcomes (e.g., knowledge, attitudes). Conclusions. After 12 months, Reducing the Risk was unsuccessful at changing sexual behaviors. Other results were mixed, but promising evidence (e.g., behavioral impacts at 1 site, impacts on intermediate outcomes) suggests potential for more widespread behavioral impacts over a longer term. [ABSTRACT FROM AUTHOR]

Background: The purpose of this paper is to describe the Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS) study, a cooperative implementation science initiative involving the National Institute on Drug Abuse, six research centers, a coordinating center, and Juvenile Justice Partners representing seven US states. While the pooling of resources across centers enables a robust implementation study design involving 36 juvenile justice agencies and their behavioral health partner agencies, co-producing a study protocol that has potential to advance implementation science, meets the needs of all constituencies (funding agency, researchers, partners, study sites), and can be implemented with fidelity across the cooperative can be challenging. This paper describes (a) the study background and rationale, including the juvenile justice context and best practices for substance use disorders, (b) the selection and use of an implementation science framework to guide study design and inform selection of implementation components, and (c) the specific study design elements, including research questions, implementation interventions, measurement, and analytic plan.Methods/design: The JJ-TRIALS primary study uses a head-to-head cluster randomized trial with a phased rollout to evaluate the differential effectiveness of two conditions (Core and Enhanced) in 36 sites located in seven states. A Core strategy for promoting change is compared to an Enhanced strategy that incorporates all core strategies plus active facilitation. Target outcomes include improvements in evidence-based screening, assessment, and linkage to substance use treatment.Discussion: Contributions to implementation science are discussed as well as challenges associated with designing and deploying a complex, collaborative project.Trial Registration: NCT02672150 . [ABSTRACT FROM AUTHOR]

Objectives. We determined whether public funding for contraception was associated with long-acting reversible contraceptive (LARC) use when providers received training on these methods. Methods. We evaluated the impact of a clinic training intervention and public funding on LARC use in a cluster randomized trial at 40 randomly assigned clinics across the United States (2011-2013).Twenty intervention clinics received a 4-hour training. Women aged 18 to 25 were enrolled and followed for 1 year (n = 1500:802 intervention, 698 control). We estimated the effects of the intervention and funding sources on LARC initiation with Cox proportional hazards models with shared frailty. Results. Women at intervention sites had higher LARC initiation than those at control (22 vs 18 per 100 person-years; adjusted hazard ratio [AHR] = 1.43; 95% confidence interval [CI] = 1.04, 1.98). Participants receiving care at clinics with Medicaid family planning expansion programs had almost twice the initiation rate as those at clinics without (25 vs 13 per 100 person-years; AHR = 2.26; 95% CI = 1.59, 3.19). LARC initiation also increased among participants with public (AHR= 1.56; 95% CI = 1.09, 2.22) but not private health insurance. Conclusions. Public funding and provider training substantially improve LARC access. [ABSTRACT FROM AUTHOR]

Background: Older adults are the fastest growing segment of the United States population. There is an immediate need to identify novel, cost-effective community-based approaches that promote health and well-being for older adults, particularly those from diverse racial/ethnic and socioeconomic backgrounds. Because choral singing is multi-modal (requires cognitive, physical, and psychosocial engagement), it has the potential to improve health outcomes across several dimensions to help older adults remain active and independent. The purpose of this study is to examine the effect of a community choir program (Community of Voices) on health and well-being and to examine its costs and cost-effectiveness in a large sample of diverse, community-dwelling older adults.Method/design: In this cluster randomized controlled trial, diverse adults age 60 and older were enrolled at Administration on Aging-supported senior centers and completed baseline assessments. The senior centers were randomly assigned to either start the choir immediately (intervention group) or wait 6 months to start (control). Community of Voices is a culturally tailored choir program delivered at the senior centers by professional music conductors that reflects three components of engagement (cognitive, physical, and psychosocial). We describe the nature of the study including the cluster randomized trial study design, sampling frame, sample size calculation, methods of recruitment and assessment, and primary and secondary outcomes.Discussion: The study involves conducting a randomized trial of an intervention as delivered in "real-world" settings. The choir program was designed using a novel translational approach that integrated evidence-based research on the benefits of singing for older adults, community best practices related to community choirs for older adults, and the perspective of the participating communities. The practicality and relatively low cost of the choir intervention means it can be incorporated into a variety of community settings and adapted to diverse cultures and languages. If successful, this program will be a practical and acceptable community-based approach for promoting health and well-being of older adults.Trial Registration: ClinicalTrials.gov NCT01869179 registered 9 January 2013. [ABSTRACT FROM AUTHOR]

Background Unintended pregnancy remains a serious public health challenge in the USA. We assessed the effects of an intervention to increase patients' access to long-acting reversible contraceptives (LARCs) on pregnancy rates. Methods We did a cluster randomised trial in 40 reproductive health clinics across the USA in 2011–13. 20 clinics were randomly assigned to receive evidence-based training on providing counselling and insertion of intrauterine devices (IUDs) or progestin implants and 20 to provide standard care. Usual costs for contraception were maintained at all sites. We recruited women aged 18–25 years attending family planning or abortion care visits and not desiring pregnancy in the next 12 months. The primary outcome was selection of an IUD or implant at the clinic visit and secondary outcome was pregnancy within 12 months. We used generalised estimating equations for clustered data to measure the intervention effect on contraceptive selection, and used survival analysis to assess pregnancy rates. Findings Of 1500 women enrolled, more at intervention than control sites reported receiving counselling on IUDs or implants (565 [71%] of 797 vs 271 [39%] of 693, odds ratio 3·8, 95% CI 2·8–5·2) and more selected LARCs during the clinic visit (224 [28%] vs 117 [17%], 1·9, 1·3–2·8). The pregnancy rate was lower in intervention group than in the control group after family planning visits (7·9 vs 15·4 per 100 person-years), but not after abortion visits (26·5 vs 22·3 per 100 person-years). We found a significant intervention effect on pregnancy rates in women attending family planning visits (hazard ratio 0·54, 95% CI 0·34–0·85). Interpretation The pregnancy rate can be reduced by provision of counselling on long-term reversible contraception and access to devices during family planning counselling visits. INSET: Panel: Research in context.. [ABSTRACT FROM AUTHOR]

Background: Seasonal influenza vaccine (SIV) uptake in the United States remains suboptimal, requiring new and innovative strategies.Objective: To evaluate the impact of a behavioral peer comparison (PC) intervention on SIV uptake in community pharmacies across the United States.Methods: A cluster randomized study was conducted across a national network of Walmart community pharmacies (> 4500 sites) during the 2019-2020 influenza season. The clusters consisted of 416 markets, each containing an average of 11 pharmacies. All pharmacies in a market were randomly assigned to either no intervention or the PC intervention, a software-delivered communication informing on-site staff, including pharmacists and pharmacy technicians, of their pharmacy's weekly performance, measured as SIV doses administered, compared with that of peer pharmacies within their market. The outcome was the pharmacy-level cumulative SIV doses administered during the intervention period (September 1, 2019,-February 29, 2020). Linear regression models were used to estimate the PC impact, with multiway cluster-robust SEs estimated by market and state.Results: A total of 4589 pharmacies were enrolled in the study, with 2297 (50.1%) randomized to the control group and 2292 (49.9%) randomized to the PC intervention group. Overall, compared with the control pharmacies, the PC pharmacies administered 3.7% (95% CI -0.3% to 7.9%) additional SIV doses. Among large-format pharmacies, the PC pharmacies administered 4.1% (95% CI 0.1%-8.3%) additional SIV doses compared with the controls. Historically low-performing large-format PC pharmacies administered 6.1% (95% CI 0.5%-11.9%) additional SIV doses compared with the controls. No statistically significant treatment effects were observed among small-format pharmacies.Conclusion: Our findings demonstrate that PCs can improve SIV uptake among large-format community pharmacies, with historically low-performing pharmacies potentially exhibiting the greatest relative impact. Wide-scale implementation of PCs in community pharmacies may help to further improve SIV uptake in these settings. [ABSTRACT FROM AUTHOR]

Promoting water consumption among children in schools is a promising intervention to reduce sugar-sweetened beverage (SSB) intake and achieve healthful weight. To date, no studies in the United States have examined how a school-based water access and promotion intervention affects students' beverage and food intake both in and out of school and weight gain over time. The Water First trial is intended to evaluate these interventions. Informed by the PRECEDE-PROCEED model and Social Cognitive Theory, the Water First intervention includes: 1) installation of lead-free water stations in cafeterias, physical activity spaces, and high-traffic common areas in lower-income public elementary schools, 2) provision of cups/reusable water bottles for students, and 3) a 6-month healthy beverage education campaign. A five year-long cluster randomized controlled trial of 26 low-income public elementary schools in the San Francisco Bay Area is examining how Water First impacts students' consumption of water, caloric intake from foods and beverages, and BMI z-score and overweight/obesity prevalence, from baseline to 7 months and 15 months after the start of the study. Intervention impact on outcomes will be examined using a difference-in-differences approach with mixed-effects regression accounting for the clustering of students in schools and classrooms. This paper describes the rationale, study design, and protocol for the Water First study. If the intervention is effective, findings will inform best practices for implementing school water policies, as well as the development of more expansive policies and programs to promote and improve access to drinking water in schools. [ABSTRACT FROM AUTHOR]

Background: Approximately 2 million children are hospitalized each year in the United States, with more than three-quarters of non-elective hospitalizations admitted through emergency departments (EDs). Direct admission, defined as admission to hospital without first receiving care in the hospital's ED, may offer benefits for patients and healthcare systems in quality, timeliness, and experience of care. While ED utilization patterns are well studied, there is a paucity of research comparing the effectiveness of direct and ED admissions. The overall aim of this project is to compare the effectiveness of a standardized direct admission approach to admission beginning in the ED for hospitalized children.Methods/design: We will conduct a stepped wedge cluster randomized controlled trial at 3 structurally and geographically diverse hospitals. A total of 70 primary and urgent care practice sites in the hospitals' catchment areas will be randomized to a time point when they will begin participation in the multi-stakeholder informed direct admission program. This crossover will be unidirectional and occur at 4 time points, 6 months apart, over a 24-month implementation period. Our primary outcome will be the timeliness of clinical care provision. Secondary outcomes include (i) parent-reported experience of care, (ii) unanticipated transfer to the intensive care unit within 6 h of hospital admission, and (iii) rapid response calls within 6 h of hospital admission. We anticipate that 190 children and adolescents will be directly admitted, with 1506 admitted through EDs. Analyses will compare the effectiveness of direct admission to admission through the ED and will evaluate the causal effect of implementing a direct admission program using linear regression with random effects for referring practice clusters and time period fixed effects. We will further examine the heterogeneity of treatment effects based on hypotheses specified a priori. In addition, we will conduct a mixed-methods process evaluation to assess reach, effectiveness, adoption, implementation, and maintenance of our direct admission intervention.Discussion: Our study represents the first randomized controlled trial to compare the effectiveness of direct admission to admission through the ED for pediatric patients. Our scientific approach, pairing a stepped wedge design with a multi-level assessment of barriers to and facilitators of implementation, will generate valuable data about how positive findings can be reproduced across other healthcare systems.Trial Registration: ClinicalTrials.gov NCT04192799 . Registered on December 10, 2019). [ABSTRACT FROM AUTHOR]

Despite widespread use of learning collaboratives in health care, few randomized trials have evaluated their effectiveness. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to standard individual technical assistance. Forty-eight mental health provider organizations from across the United States will be recruited to participate in the trial. The evidence-based practice to be implemented is the InSHAPE health promotion intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The primary outcomes are InSHAPE program participation and fidelity, and participant weight loss; secondary outcomes are program operation, program uptake, participant health behaviors of physical activity and nutrition, organizational change, and program sustainment. Implementation outcomes are measured at 3, 6, 12, 18, and 24 months after the program start-up. Participant-level outcomes are measured at fixed intervals every 3 months after each participant enrolls in the study. This study will determine whether VLCs are an effective implementation strategy among resource-limited providers when the new practice necessitates a shift in mission, scope of practice, type of services delivered, and new financing. ClinicalTrials.gov identifier: NCT03891368 Registered 25 March 2019, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03891368?term=NCT03891368&rank=1 [ABSTRACT FROM AUTHOR]

Background: Excessive weight gain among young adult women age 18-45 years is an alarming and overlooked trend that must be addressed to reverse the epidemics of obesity and chronic disease. During this vulnerable period, women tend to gain disproportionally large amounts of weight compared to men and to other life periods. Healthy Eating and Active Living Taught at Home (HEALTH) is a lifestyle modification intervention developed in partnership with Parents as Teachers (PAT), a national home visiting, community-based organization with significant reach in this population. HEALTH prevented weight gain, promoted sustained weight loss, and reduced waist circumference. PAT provides parent-child education and services free of charge to nearly 170,000 families through up to 25 free home visits per year until the child enters kindergarten.Methods: This study extends effectiveness findings with a pragmatic cluster randomized controlled trial to evaluate dissemination and implementation (D&I) of HEALTH across three levels (mother, parent educator, PAT site). The trial will evaluate the effect of HEALTH and the HEALTH training curriculum (implementation strategy) on weight among mothers with overweight and obesity across the USA (N = 252 HEALTH; N = 252 usual care). Parent educators from 28 existing PAT sites (14 HEALTH, 14 usual care) will receive the HEALTH training curriculum through PAT National Center, using PAT's existing training infrastructure, as a continuing education opportunity. An extensive evaluation, guided by RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance), will determine implementation outcomes (acceptability, adoption, appropriateness, feasibility, fidelity, and adaptation) at the parent educator level. The Conceptual Framework for Implementation Research will characterize determinants that influence HEALTH D&I at three levels: mother, parent educator, and PAT site to enhance external validity (reach and maintenance).Discussion: Embedding intervention content within existing delivery channels can help expand the reach of evidence-based interventions. Interventions, which have been adapted, can still be effective even if the effect is reduced and can still achieve population impact by reaching a broader set of the population. The current study will build on this to test not only the effectiveness of HEALTH in real-world PAT implementation nationwide, but also elements critical to D&I, implementation outcomes, and the context for implementation.Trial Registration: https://ClinicalTrials.gov , NCT03758638 . Registered 29 November 2018. [ABSTRACT FROM AUTHOR]

Background: Understanding how contraceptive choices and access differ for women having medication abortions compared to aspiration procedures can help to identify priorities for improved patient-centered postabortion contraceptive care.Objective: The objective of this study was to investigate the differences in contraceptive counseling, method choices, and use between medication and aspiration abortion patients.Study Design: This subanalysis examines data from 643 abortion patients from 17 reproductive health centers in a cluster, randomized trial across the United States. We recruited participants aged 18-25 years who did not desire pregnancy and followed them for 1 year. We measured the effect of a full-staff contraceptive training and abortion type on contraceptive counseling, choice, and use with multivariable regression models, using generalized estimating equations for clustering. We used survival analysis with shared frailty to model actual intrauterine device and subdermal implant initiation over 1 year.Results: Overall, 26% of participants (n = 166) had a medication abortion and 74% (n = 477) had an aspiration abortion at the enrollment visit. Women obtaining medication abortions were as likely as those having aspiration abortions to receive counseling on intrauterine devices or the implant (55%) and on a short-acting hormonal method (79%). The proportions of women choosing to use these methods (29% intrauterine device or implant, 58% short-acting hormonal) were also similar by abortion type. The proportions of women who actually used short-acting hormonal methods (71% medication vs 57% aspiration) and condoms or no method (20% vs 22%) within 3 months were not significantly different by abortion type. However, intrauterine device initiation over a year was significantly lower after the medication than the aspiration abortion (11 per 100 person-years vs 20 per 100 person-years, adjusted hazard ratio, 0.50; 95% confidence interval, 0.28-0.89). Implant initiation rates were low and similar by abortion type (5 per 100 person-years vs 4 per 100 person-years, adjusted hazard ratio, 2.41; 95% confidence interval, 0.88-6.59). In contrast to women choosing short-acting methods, relatively few of those choosing a long-acting method at enrollment, 34% of medication abortion patients and 53% of aspiration abortion patients, had one placed within 3 months. Neither differences in health insurance nor pelvic examination preferences by abortion type accounted for lower intrauterine device use among medication abortion patients.Conclusion: Despite similar contraceptive choices, fewer patients receiving medication abortion than aspiration abortion initiated intrauterine devices over 1 year of follow-up. Interventions to help patients receiving medication abortion to successfully return for intrauterine device placement are warranted. New protocols for same-day implant placement may also help patients receiving medication abortion and desiring a long-acting method to receive one. [ABSTRACT FROM AUTHOR]

Background: Almost one-half of women having an abortion in the United States have had a previous procedure, which highlights a failure to provide adequate preventive care. Provision of intrauterine devices and implants, which have high upfront costs, can be uniquely challenging in the abortion care setting.Objective: We conducted a study of a clinic-wide training intervention on long-acting reversible contraception and examined the effect of the intervention, insurance coverage, and funding policies on the use of long-acting contraceptives after an abortion.Study Design: This subanalysis of a cluster, randomized trial examines data from the 648 patients who had undergone an abortion who were recruited from 17 reproductive health centers across the United States. The trial followed participants 18-25 years old who did not desire pregnancy for a year. We measured the effect of the intervention, health insurance, and funding policies on contraceptive outcomes, which included intrauterine device and implant counseling and selection at the abortion visit, with the use of logistic regression with generalized estimating equations for clustering. We used survival analysis to model the actual initiation of these methods over 1 year.Results: Women who obtained abortion care at intervention sites were more likely to report intrauterine device and implant counseling (70% vs 41%; adjusted odds ratio, 3.83; 95% confidence interval, 2.37-6.19) and the selection of these methods (36% vs 21%; adjusted odds ratio, 2.11; 95% confidence interval, 1.39-3.21). However, the actual initiation of methods was similar between study arms (22/100 woman-years each; adjusted hazard ratio, 0.88; 95% confidence interval, 0.51-1.51). Health insurance and funding policies were important for the initiation of intrauterine devices and implants. Compared with uninsured women, those women with public health insurance had a far higher initiation rate (adjusted hazard ratio, 2.18; 95% confidence interval, 1.31-3.62). Women at sites that provide state Medicaid enrollees abortion coverage also had a higher initiation rate (adjusted hazard ratio, 1.73; 95% confidence interval, 1.04-2.88), as did those at sites with state mandates for private health insurance to cover contraception (adjusted hazard ratio, 1.80; 95% confidence interval, 1.06-3.07). Few of the women with private insurance used it to pay for the abortion (28%), but those who did initiated long-acting contraceptive methods at almost twice the rate as women who paid for it themselves or with donated funds (adjusted hazard ratio, 1.94; 95% confidence interval, 1.10-3.43).Conclusions: The clinic-wide training increased long-acting reversible contraceptive counseling and selection but did not change initiation for abortion patients. Long-acting method use after abortion was associated strongly with funding. Restrictions on the coverage of abortion and contraceptives in abortion settings prevent the initiation of desired long-acting methods. [ABSTRACT FROM AUTHOR]