Hybrid Effectiveness-implementation Trial Research Articles

An effectiveness-implementation hybrid trial of phone-based tobacco cessation interventions in the Lebanese primary healthcare system: protocol for project PHOENICS

BackgroundTobacco use remains the leading cause of preventable disease, disability, and death in the world. Lebanon has an exceptionally high tobacco use burden. The World Health Organization endorses smoking cessation advice integrated into primary care settings as well as easily accessible and free phone-based counseling and low-cost pharmacotherapy as standard of practice for population-level tobacco dependence treatment. Although these interventions can increase access to tobacco treatment and are highly cost-effective compared with other interventions, their evidence base comes primarily from high-income countries, and they have rarely been evaluated in low- and middle-income countries. Recommended interventions are not integrated as a routine part of primary care in Lebanon, as in other low-resource settings. Addressing this evidence-to-practice gap requires research on multi-level interventions and contextual factors for implementing integrated, scalable, and sustainable cessation treatment within low-resource settings.MethodsThe objective of this study is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based tobacco treatment in primary healthcare centers within the Lebanese National Primary Healthcare Network. We will adapt and tailor an existing in-person smoking cessation program to deliver phone-based counseling to smokers in Lebanon. We will then conduct a three-arm group-randomized trial of 1500 patients across 24 clinics comparing (1) ask about tobacco use; advise to quit; assist with brief counseling (AAA) as standard care; (2) ask; advise; connect to phone-based counseling (AAC); and (3) AAC + nicotine replacement therapy (NRT). We will also evaluate the implementation process to measure factors that influence implementation. Our central hypothesis is that connecting patients to phone-based counseling with NRT is the most effective alternative. This study will be guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, supported by Proctor’s framework for implementation outcomes.DiscussionThe project addresses the evidence-to-practice gap in the provision of tobacco dependence treatment within low-resource settings by developing and testing contextually tailored multi-level interventions while optimizing implementation success and sustainability. This research is significant for its potential to guide the large-scale adoption of cost-effective strategies for implementing tobacco dependence treatment in low-resource settings, thereby reducing tobacco-related morbidity and mortality.Trial registrationClinicalTrials.gov, NCT05628389, Registered 16 November 2022.

MHealth to improve implementation of TB contact investigation: a case study from Uganda

BackgroundImplementation science offers a systematic approach to adapting innovations and delivery strategies to new contexts but has yet to be widely applied in low- and middle-income countries. The Fogarty Center for Global Health Studies is sponsoring a special series, “Global Implementation Science Case Studies,” to address this gap.MethodsWe developed a case study for this series describing our approach and lessons learned while conducting a prospective, multi-modal study to design, implement, and evaluate an implementation strategy for TB contact investigation in Kampala, Uganda. The study included formative, evaluative, and summative phases that allowed us to develop and test an adapted contact investigation intervention involving home-based sample collection for TB and HIV testing. We concurrently developed a multi-component mHealth implementation strategy involving fingerprint scanning, electronic decision support, and automated reporting of test results via text message. We then conducted a household-randomized, hybrid implementation-effectiveness trial comparing the adapted intervention and implementation strategy to usual care. Our assessment included nested quantitative and qualitative studies to understand the strategy’s acceptability, appropriateness, feasibility, fidelity, and costs. Reflecting on this process with a multi-disciplinary team of implementing researchers and local public health partners, we provide commentary on the previously published studies and how the results influenced the adaptation of international TB contact investigation guidelines to fit the local context.ResultsWhile the trial did not show improvements in contact investigation delivery or public health outcomes, our multi-modal evaluation strategy helped us identify which elements of home-based, mHealth-facilitated contact investigation were feasible, acceptable, and appropriate and which elements reduced its fidelity and sustainability, including high costs. We identified a need for better tools for measuring implementation that are simple, quantitative, and repeatable and for greater attention to ethical issues in implementation science.ConclusionsOverall, a theory-informed, community-engaged approach to implementation offered many learnings and actionable insights for delivering TB contact investigation and using implementation science in low-income countries. Future implementation trials, especially those incorporating mHealth strategies, should apply the learnings from this case study to enhance the rigor, equity, and impact of implementation research in global health settings.

Feasibility and acceptability of a low-resource-intensive, transdiagnostic intervention for children with social-communication challenges in early childhood education settings.

Preschool classrooms provide a unique context for supporting the development of children with social-communication challenges. This study is an uncontrolled clinical trial of an adapted professional development intervention for preschool teachers (Social Emotional Engagement-Knowledge & Skills-Early Childhood). Social Emotional Engagement-Knowledge & Skills-Early Childhood is a low-resource-intensive, transdiagnostic intervention to address the learning needs of children with social-communication challenges and consists of four asynchronous online modules and three synchronous coaching sessions. The current research evaluated the feasibility and acceptability of intervention and research procedures, implemented in authentic early childhood education settings. Participants included one teacher and one target child with social-communication challenges from 25 preschool classrooms, sampled to maximize variability. Overall, the current research revealed high levels of feasibility, with 9 out of 10 benchmarks met: (a) procedures for participant recruitment reliably identified a neurodiverse sample of children with teacher-reported social-communication challenges; (b) teachers showed high levels of program engagement and Social Emotional Engagement-Knowledge & Skills-Early Childhood completion (76%); and (c) results revealed a robust pattern of gains in Social Emotional Engagement-Knowledge & Skills-Early Childhood classrooms and associations among key outcome measures (including active engagement, student teacher relationship, social-communication competencies). Implications for the design of a subsequent, larger effectiveness-implementation hybrid trial (Type 1) are discussed.

Clinic reported facilitators and barriers to pediatric cancer survivor care delivery among survivorship clinics: A fishbone analysis.

Childhood cancer survivors need regular, long-term survivor care. The Children's Oncology Group (COG) recommends that pediatric patients receive ongoing, evidence-based surveillance for late effects, beginning 2years after the completion of cancer therapy. However, at least a third of survivors are not engaging in long-term survivorship care. This study assessed facilitators and barriers to follow-up survivorship care through the perspectives of pediatric cancer survivor clinic representatives. As part of a hybrid implementation-effectiveness trial, a representative from 12 participating pediatric cancer survivor clinics completed a survey about site characteristics and a semi-structured interview on facilitators and barriers to survivor care delivery at their institution. Interviews were grounded in the socio-ecological model (SEM) framework and utilized a fishbone diagram to understand what facilitates and impedes survivor care. We ran descriptive statistics and conducted thematic analyses of the interview transcripts to create two meta-fishbone diagrams. All participating clinics (N=12) have existed for at least 5years (mean=15, median=13, range=3-31), and half (n=6, 50%) reported seeing more than 300 survivors annually. In the fishbone diagram, the top facilitators were in the SEM domain of organization, specifically with familiar staff (n=12, 100%), resource utilization (n=11, 92%), dedicated survivorship staff (n=10, 83%), and clinic processes (n=10, 83%). Common barriers were across the domains of organization, community, and policy, which included distance/transportation to the clinic (n=12, 100%), technology limits (n=11, 92%), scheduling issues (n=11, 92%), and insufficient funding/insurance (n=11, 92%). Clinic staff and provider perceptions are instrumental in understanding multilevel contextual issues related to survivor care delivery for pediatric cancer survivor clinics. Future research can aid in developing education, processes, and services to promote cancer survivor follow-up care.

Optimizing Medication Safety with Oral Antitumor Therapy: A Methodological Approach for the Real-World Implementation of the AMBORA Competence and Consultation Center.

Generating evidence for the efficacy of an intervention is not sufficient to guarantee its implementation in real-world settings. The randomized AMBORA trial (Medication Safety with Oral Antitumor Therapy) demonstrated that an intensified clinical pharmacological/pharmaceutical care program has substantial benefits for patients, treatment teams, and the healthcare system. Thus, we are now investigating its implementation into routine care within the AMBORA Competence and Consultation Center (AMBORA Center). We perform a multicenter type III hybrid trial following the RE-AIM framework to assess the clinical effectiveness of this care program under real-world conditions, while evaluating the implementation outcomes. Semi-structured stakeholder interviews based on the Consolidated Framework for Implementation Research (CFIR) have been conducted to identify barriers and facilitators. So far, 332 patients treated with oral antitumor drugs have been referred to the AMBORA Center by 66 physicians from 13 independent clinical units. In 20 stakeholder interviews (e.g., with clinic directors), 30% (6/20) of the interviewees anticipated possible barriers which may partly hinder sustainable implementation (e.g., unavailable consultation rooms). Furthermore, important facilitators (e.g., operational processes) were identified. This methodological description adds knowledge on how to structure a hybrid effectiveness-implementation trial and proposes multilevel implementation strategies to improve the medication safety of oral antitumor therapy.

Improving quality of life in patients with rare autoimmune liver diseases by structured peer-delivered support (Q.RARE.LI): Study protocol for a transnational effectiveness-implementation hybrid trial

Improving quality of life in patients with rare autoimmune liver diseases by structured peer-delivered support (Q.RARE.LI): Study protocol for a transnational effectiveness-implementation hybrid trial

Equipping future teachers with innovative strategies that increase physical activity in the classroom: a hybrid implementation trial across three Australian universities

IntroductionTransformEd targets initial teacher education (ITE) to equip future teachers with innovative strategies that increase physical activity in the Primary school classroom.MethodsThis hybrid implementation-effectiveness trial investigated the effects of the TransformEd program when embedded in ITE degrees at two Australian universities (University 1 Single Unit offering; University 2 Dual Unit offering) over a 12-week period, on pre-service teachers’ perceived competence, confidence, and willingness to deliver active pedagogies, in comparison with a third ‘usual practice’ control university.ResultsThere was a favourable intervention effect on the total teacher perceptions score among pre-service teachers in University 1 compared to the control group pre-service teachers. Further, there was a significant intervention effect on reduced perceived barriers to active strategies in University 1, and a significant increase in perceived effects of active strategies on Primary school student outcomes in University 2. Qualitative data suggested the program strengthened the connection between theory and practice (i.e., how pre-service teachers are educated in university and the way they teach in Primary schools). The program was motivating to both lecturers and pre-service teachers, resulted in them reflecting on their own teaching practice, and helped with pre-service teacher engagement.DiscussionRecommendations for improvement included stronger and more explicit alignment with the Australian Professional Standards for Teachers.

The SERENITY study: online Mindfulness-Based Cancer Recovery (e-MBCR) program for women living with breast and gynecological cancer—protocol for a pilot effectiveness-implementation randomized trial

ABSTRACT Background: Mindfulness-Based Interventions (MBIs) have been shown to improve mental and physical health as well as biological processes of patients living with cancer. More research is needed to inform on the determinants that might facilitate or hinder their implementation in hospitals. The primary objective of this study was to explore the feasibility and implementation of an online Mindfulness-Based Cancer Recovery program (e-MBCR) for women with breast and gynecological cancer treated at two academic oncology centers in Switzerland. The secondary objective was to explore the psychological and biological effects of the program. Methods: The SERENITY study is a pilot hybrid effectiveness-implementation trial using a randomized waitlist-controlled design, including a mixed methods approach. The intervention groups receive treatment as usual and the e-MBCR program, whereas the control groups are on a wait-list to receive an online Mindfulness-Based Stress Reduction program at the end of the study. Four e-MBCR programs are delivered consecutively, with 12 patients in each group. Participants' attendance to the sessions is the primary outcome. Implementation outcomes of interest are feasibility, acceptability, appropriateness, fidelity, costs, and early sustainability. Implementation determinants will be described, and an exploratory analysis of psychological outcomes and cancer-related biomarkers will be performed at three time points (baseline, postintervention, and 3 months of follow-up). Discussion: The results of this study will inform a future large trial and adjustments needed for a real-world implementation of the program. The translational part of this study will contribute to the collective effort to better understand how MBIs affect important cancer-related biomarkers.

A Brief Intervention for Improving Alcohol Literacy and Addressing Harmful Alcohol Use Among Women Attending an Australian Breast Screening Service (Health4her): Protocol for a Hybrid Effectiveness-Implementation Trial.

Alcohol consumption is a major modifiable risk factor for female breast cancer, even in small amounts. However, awareness of this risk remains low. National breast screening programs are uniquely positioned to provide timely and targeted health information and behavior change strategies to improve alcohol literacy and reduce consumption. A breast screening service is a novel health care setting for brief alcohol intervention, with the potential for extensive reach. This study aimed to conduct a formative evaluation with breast screening service consumers to understand the need for, and acceptability of, brief alcohol intervention in the breast screening setting and collaboratively design a brief alcohol intervention (Health4Her); to test the effectiveness of Health4Her in improving knowledge of alcohol as a breast cancer risk factor (primary outcome), improving alcohol literacy, and reducing consumption among women attending a breast screening service; and to examine the implementation strategy through process evaluation. This was a hybrid type II effectiveness-implementation trial comprising a randomized controlled trial (RCT) alongside a mixed methods program evaluation guided by applicable elements of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework and Consolidated Framework for Implementation Research. Formative evaluation comprised a retrospective analysis of alcohol consumption data (n=49,240), a web-based survey (n=391), and focus groups and interviews (n=31) with breast screening service consumers. Women attending routine mammography, drinking at any level, were recruited to the single-site, double-blind RCT (n=558), and completed a baseline assessment before randomization (1:1) to receive Health4Her (alcohol brief intervention + lifestyle information) or control (lifestyle information) via animation on an iPad. Follow-up assessments were performed 4 and 12 weeks after randomization. The process evaluation included evaluation of trial administrative data, participant quantitative (n=497) and qualitative feedback (n=30), and site staff qualitative feedback (n=11). This research was funded in March and May 2019. Data collection for the formative evaluation and trial recruitment occurred between January and April 2020 and February and August 2021, respectively, with finalization of follow-up data collection in December 2021. Quantitative process evaluation data were collected during trial implementation, and collection of participant and staff feedback was finalized in December 2021. Results of the retrospective analysis of alcohol consumption data from breast screening service consumers is anticipated to be published in March 2023 and the results of the RCT to be published in March 2023. This study is anticipated to generate new substantial knowledge on the alcohol consumption and literacy needs of women attending breast screening and the extent to which these can be addressed using a novel, tailored brief alcohol intervention. The study design permits the evaluation of the effectiveness and implementation of Health4Her to predict and facilitate uptake in breast screening services. ClinicalTrials.gov NCT04715516; https://clinicaltrials.gov/ct2/show/NCT04715516. RR1-10.2196/44867.

Improving quality of life in patients with rare autoimmune liver diseases by structured peer-delivered support (Q.RARE.LI): study protocol for a transnational effectiveness-implementation hybrid trial

BackgroundPsychosocial support is a crucial component of adequate rare disease care, but to date psychosocial support needs of this patient population are insufficiently met. Within Q.RARE.LI, we strive to evaluate the effectiveness of a structured, transdiagnostic, and location-independent psychosocial support intervention in routine care of patients with rare autoimmune liver diseases in five countries and prepare its implementation.MethodsWithin an effectiveness-implementation hybrid trial, we aim to a) investigate the effectiveness of the intervention in routine care in five diverse healthcare systems and b) assess implementation outcomes, examine and prepare the implementation context, and develop country-specific implementation strategies. To assess effectiveness, we will include N = 240 patients with rare autoimmune liver diseases. Within a two-armed randomized controlled trial (allocation ratio 1:1), we will compare structured and peer-delivered psychosocial support in addition to care-as-usual (CAU) with CAU alone. Outcomes will be assessed via electronic database entry prior to intervention, directly after, and at a three-month follow-up. Our primary effectiveness outcome will be mental health-related quality of life at post-assessment. Secondary outcomes include depression and anxiety severity, perceived social support, helplessness, and disease acceptance. Implementation outcomes will be assessed within a mixed-methods process evaluation. In a quantitative cross-sectional survey, we will examine perceived acceptability and feasibility in patients, peer-counselors, and healthcare providers involved in delivery of the intervention. In qualitative focus groups, we will analyze the implementation context and determine barriers and facilitators for implementation with different stakeholders (patients and/or representatives, peer-counselors, healthcare providers, health insurers). Based on these results, we will derive country-specific implementation strategies and develop a concrete implementation plan for each country.DiscussionThe intervention is expected to help patients adjust to their disease and improve their mental quality of life. The transdiagnostic and location-independent program has the potential to reach patients for psychosocial support who are usually hard to reach. By preparing the implementation in five countries, the project can help to make low-threshold psychosocial support available to many patients with rare diseases and improve comprehensive healthcare for an often neglected group.Trial registrationISRCTN15030282

A Multicomponent Intervention to Train and Support Family Medicine Providers to Promote Pre-exposure Prophylaxis (PrEP) for Adolescent Girls and Young Women in the Deep South: Protocol for the PrEP-Pro Study.

Pre-exposure prophylaxis (PrEP) is a highly effective biomedical prevention intervention and a major strategy for reducing the HIV burden in the United States. However, PrEP provision and uptake remain lower than estimated needs, and in ways that may exacerbate HIV disparities among Black adolescent girls and young women in the southern United States. Data suggest that gaps in provider knowledge of HIV epidemiology and PrEP and skills assessing sexual health practices are important barriers to provision and uptake, with limited evidence-based interventions to address these gaps. This paper describes the "PrEP-Pro" intervention, a multicomponent intervention to train and support family medicine (FM) trainees to promote PrEP for adolescent girls and young women in Alabama. The PrEP-Pro intervention comprises 3 main components guided by the Capability-Opportunity-Motivation-Behavior (COM-B) model for behavioral change and the Consolidated Framework for Implementation Research (CFIR): (1) provider HIV epidemiology and PrEP education, (2) sexual history taking, and (3) PrEP Champions. In phase 1, we will work with community advisory boards (providers and clients) and then conduct focus groups with FM trainees to adapt content to train FM residents on HIV epidemiology and PrEP and develop implementation strategies, including provider-facing tools and client-facing educational materials. In phase 2, we will pretest and then pilot-test the initially adapted PrEP-Pro intervention with FM trainees. FM trainees will complete baseline, 3-, and 6-month questionnaires post PrEP-Pro intervention. We will also conduct in-depth interviews (IDIs) with FM pilot participants, adolescent girls and young women who accessed care after the PrEP-Pro pilot, and key stakeholders. The primary outcomes are PrEP-Pro acceptability and feasibility, which would be assessed using validated instruments at months 3 (among pretest participants) and 6 (among pilot participants). Secondary outcomes will also be assessed, including PrEP knowledge, sexual history-taking attitudes and practices, PrEP prescriptions among adolescent girls and young women encounters, and sexually transmitted infections (STIs) and HIV testing among adolescent girls and young women encounters in 6 months. Study results will be disseminated to practices, state health officials, and other key stakeholders to solicit feedback on implementation opportunities and challenges to inform a hybrid effectiveness implementation trial. Our results will also be presented at local and national conferences and submitted to peer-reviewed journals. As PrEP grows, there is a pressing need to train FM providers and develop appropriate, contextually relevant tools to support PrEP implementation. The PrEP-Pro intervention is a multicomponent intervention to train FM residents across Alabama on sexual history-taking, PrEP provision for adolescent girls and young women, and supporting practice-based PrEP Champions. The PrEP-Pro intervention is anticipated to increase PrEP prescriptions for adolescent girls and young women and expand comprehensive sexual and reproductive health care for adolescent girls and young women in rural and urban Alabama. PRR1-10.2196/44908.

Prevention of non-ventilator-associated hospital-acquired pneumonia in Switzerland: a type 2 hybrid effectiveness–implementation trial

Non-ventilator-associated hospital-acquired pneumonia (nvHAP) is a frequent, but under-researched infection. We aimed to simultaneously test an nvHAP prevention intervention and a multifaceted implementation strategy. In this single-centre, type 2 hybrid effectiveness-implementation study, all patients of nine surgical and medical departments at the University Hospital Zurich, Switzerland, were included and surveyed over three study periods: baseline (14-33 months, depending on department), implementation (2 months), and intervention (3-22 months, depending on department). The five-measure nvHAP prevention bundle consisted of oral care, dysphagia screening and management, mobilisation, discontinuation of non-indicated proton-pump inhibitors, and respiratory therapy. The implementation strategy comprised department-level implementation teams who conducted and locally adapted the core strategies of education, training, and changing infrastructure. Intervention effectiveness on the primary outcome measure of nvHAP incidence rate was quantified using a generalised estimating equation method in a Poisson regression model, with hospital departments as clusters. Implementation success scores and determinants were derived longitudinally through semistructured interviews with health-care workers. This trial is registered with ClinicalTrials.gov (NCT03361085). Between Jan 1, 2017, and Feb 29, 2020, 451 nvHAP cases occurred during 361 947 patient-days. nvHAP incidence rate was 1·42 (95% CI 1·27-1·58) per 1000 patient-days in the baseline period and 0·90 (95% CI 0·73-1·10) cases per 1000 patient-days in the intervention period. The intervention-to-baseline nvHAP incidence rate ratio, adjusted for department and seasonality, was 0·69 (95% CI 0·52-0·91; p=0·0084). Implementation success scores correlated with lower nvHAP rate ratios (Pearson correlation -0·71, p=0·034). Determinants of implementation success were positive core business alignment, high perceived nvHAP risk, architectural characteristics promoting physical proximity of health-care staff, and favourable key individual traits. The prevention bundle led to a reduction of nvHAP. Knowledge of the determinants of implementation success might help in upscaling nvHAP prevention. Swiss Federal Office of Public Health.

Informing a collaborative-care model for delivering medication assisted treatment for opioid dependence (MATOD): An analysis of pharmacist, prescriber and patient perceptions.

Demand for medication assisted treatment for opioid dependence (MATOD) in Australia exceeds capacity, particularly in rural and regional areas. There is increasing recognition that community pharmacists are well-positioned to take on expanded roles in MATOD delivery, however there has been limited Australian research exploring attitudes of pharmacists, prescribers, and patients to collaborative models of care. This study aimed to better understand enablers and barriers to a collaborative model for MATOD, to inform implementation in regions where increases in treatment capacity are urgently needed. Semi-structured telephone interviews were conducted with pharmacists (n=11), prescribers (n=6), and patients (n=8) recruited from the Frankston-Mornington Peninsula region in Victoria, Australia, where transport and access to services have impacts on health care utilisation. The COM-B model was used to explore perceptions of pharmacists' capability, opportunity, and motivations for delivering collaborative care. There was strong motivation among healthcare professionals to participate in a collaborative model of care, with the main perceived benefits including improvements in accessibility, convenience, and continuity of care, and leverage of pharmacists' high level of patient engagement. Key barriers identified by both pharmacists and prescribers included a perceived lack of pharmacist skills in some areas (capability) and resources (opportunity) to deliver collaborative care in a community pharmacy setting. Established relationships between all stakeholders (social opportunity) and communication between pharmacists and prescribers were identified as facilitators. Barriers and facilitators aligned with seven key areas: skills, confidence, relationships, patient selection, protocols, communication and resources. Findings informed the development of a collaborative model that was individualised, protocol based, and supported by training and clear processes. This study identifies specific barriers and facilitators to a pharmacist-prescriber collaborative model of care for MATOD. The resulting model will be tested in a hybrid implementation-effectiveness trial in the Frankston-Mornington Peninsula region.

Dental Caries in Medicaid-Insured Preschool Children With or Without Special Health Care Needs in Northeast Ohio

Children with special health care needs (CSHCN) are recognized to be at increased risk of developing dental caries (decay). Evidence is mixed regarding the association of preventive oral health care delivered by pediatric primary care clinicians with caries experience among CSHCN. To investigate caries experience, including untreated decay, among Medicaid-enrolled preschoolers with or without special health care needs. This cross-sectional study used baseline data from the Pediatric Providers Against Cavities in Children's Teeth study, a cluster-randomized hybrid effectiveness-implementation trial conducted among 1022 Medicaid-enrolled preschoolers aged 3 to 6 years attending well-child visits at 18 participating community pediatric primary care practices in northeast Ohio. Baseline data were collected from November 1, 2017, to August 31, 2019, with statistical analyses conducted from April to August 2022. Presence of special health care needs, as assessed by applying the Pediatric Medical Complexity Algorithm to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision codes, was abstracted from electronic medical records. CSHCN were defined as having either noncomplex chronic disease (presence of only 1 nonprogressive chronic condition, or multiple nonprogressive chronic conditions in a single body system) or complex chronic disease (presence of any progressive chronic condition, malignant neoplasm, or significant chronic conditions involving multiple body systems). Untreated dental decay and caries experience as assessed through clinical dental examinations using International Caries Detection and Assessment System criteria. A total of 1022 children aged 3 to 6 years from 18 practices were enrolled in the study. The mean (SD) age of the study population was 4.3 (1.1) years, 554 (54.2%) were boys, and of 988 with data on race and ethnicity, 451 (45.6%) were Black. Of these, 301 of 1019 (29.5%) had a likely special health care need (225 with noncomplex chronic conditions and 76 with complex chronic conditions). The most frequent chronic conditions included asthma (n = 209) and mental or behavioral health disorders (n = 146), including attention-deficit/hyperactivity disorder, autism, and developmental delays. Overall, 296 children (29.0%) had untreated decay, and 378 (37.0%) had caries experience (decayed and filled teeth). Accounting for sociodemographic characteristics, CSHCN had 34% reduced odds of untreated decay (adjusted odds ratio [AOR], 0.66 [95% CI, 0.48-0.92]) compared with those with without chronic disease. In addition, caries experience was lower among CSHCN (AOR, 0.79 [95% CI, 0.60-1.04]). In this cross-sectional study of Medicaid-enrolled children who attended well-child visits as preschoolers, untreated dental decay was lower among CSHCN compared with those without chronic conditions. This study suggests that CSHCN may have had better access to the various types of dental care facilitated in medical settings.

The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines

BackgroundClinical and real-world effectiveness data for the COVID-19 vaccines have shown that they are the best defense in preventing severe illness and death throughout the pandemic. However, in the US, some groups remain more hesitant than others about receiving COVID-19 vaccines. One important group is long-term care workers (LTCWs), especially because they risk infecting the vulnerable and clinically complex populations they serve. There is a lack of research about how best to increase vaccine confidence, especially in frontline LTCWs and healthcare staff. Our aims are to: (1) compare the impact of two interventions delivered online to enhanced usual practice on LTCW COVID-19 vaccine confidence and other pre-specified secondary outcomes, (2) determine if LTCWs’ characteristics and other factors mediate and moderate the interventions’ effect on study outcomes, and (3) explore the implementation characteristics, contexts, and processes needed to sustain a wider use of the interventions.MethodsWe will conduct a three-arm randomized controlled effectiveness-implementation hybrid (type 2) trial, with randomization at the participant level. Arm 1 is a dialogue-based webinar intervention facilitated by a LTCW and a medical expert and guided by an evidence-based COVID-19 vaccine decision tool. Arm 2 is a curated social media web application intervention featuring interactive, dynamic content about COVID-19 and relevant vaccines. Arm 3 is enhanced usual practice, which directs participants to online public health information about COVID-19 vaccines. Participants will be recruited via online posts and advertisements, email invitations, and in-person visits to care settings. Trial data will be collected at four time points using online surveys. The primary outcome is COVID-19 vaccine confidence. Secondary outcomes include vaccine uptake, vaccine and booster intent for those unvaccinated, likelihood of recommending vaccination (both initial series and booster), feeling informed about the vaccines, identification of vaccine information and misinformation, and trust in COVID-19 vaccine information provided by different people and organizations. Exploration of intervention implementation will involve interviews with study participants and other stakeholders, an in-depth process evaluation, and testing during a subsequent sustainability phase.DiscussionStudy findings will contribute new knowledge about how to increase COVID-19 vaccine confidence and effective informational modalities for LTCWs.Trial registrationNCT05168800 at ClinicalTrials.gov, registered December 23, 2021.

Breast Cancer Care in Kenya – A Hybrid Approach to Clinical Data Management

Background: High-quality data is essential for guiding clinical decision-making, quality improvement initiatives, national and local policy recommendations, and outcomes measurement and reporting. In Kenya, EHRs have been implemented in several disease- and goal-specific care modules, but their post-implementation usage remains low and precludes scale-up. Maintenance costs, attitudinal-behavioral limitations, and workflow interference have limited EHR implementation in other LMIC. While continued investigation will likely refine future EHR functionality, creative solutions are needed in the meantime to supplement these efforts. The aim of this study is to describe the creation and implementation of clinical forms for the secondary development of a prospective database in a multidisciplinary breast clinic.
 Methods: We developed clinical forms and corresponding RedCAP instruments, through the following steps: (1) multidisciplinary needs assessment and plan; (2) collaborative drafting of forms; (3) iterative clinical piloting and revision; (4) harmonization of forms with RedCAP instruments; and (5) administrative approval for clinical use.
 Results: The needs assessment identified challenges related to documentation of clinical encounters. Five clinical forms were created and edited over a period of 6 months, corresponding to ten RedCAP instruments with 469 fields. These tools capture data with potential for use as quality improvement metrics, including ECOG status, clinical and pathologic staging, barriers to care, disease status and progression, treatments and other interventions, among others.
 Conclusion: We hypothesize that insight gained from EHR implementation in LMIC can be applied on a small scale to generate high-quality data and facilitate care in the absence of widespread EHR usage. These tools will be used both to develop a prospective database and to retroactively migrate legacy data for outcomes analysis of the multidisciplinary breast clinic at Moi Teaching and Referral Hospital in Eldoret, Kenya. Following administrative approval, a formative evaluation will be conducted during the clinical implementation phase in a hybrid effectiveness-implementation trial.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol

BackgroundPeople with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems. MethodsParticipants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care. The acupuncture intervention group receives 10 sessions over approximately 5 weeks. The guided relaxation intervention group receives access to video sessions ranging from 2 to 20 min each viewed daily over 5 weeks. The usual care group receives the standard of clinical care for sickle cell disease. Participants are re-randomized at 6 weeks depending on their pain impact score. Assessments occur at 6 weeks, 12 weeks, and 24 weeks. The primary outcome is the change in pain impact score and secondary measures include opioid use, anxiety, depression, sleep, pain catastrophizing, substance use, global impression of change, constipation, and hospitalizations. The GRACE study uses the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes. ConclusionThe results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease.ClinicalTrials.gov Identifier: NCT04906447.

Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA).

Children and adolescents with chronic pain are a vulnerable population who often lack the resources to manage their condition. Due to high personal, social, and economic consequences, proper management in its early stages is key to reducing disability. The aim of this project is to co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users and to evaluate its effectiveness and implementation outcomes in Spain. (Phase 1) Focus groups with patients, parents, and clinicians (n = 5-6 each) will inform about unmet pain care needs and provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based on the results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validated psychological techniques focused on improving functioning by teaching pain coping skills. (Phase 3) Hybrid effectiveness-implementation trial. Participants (n = 195) will be adolescents aged 12-17 years old with chronic pain and one of their parents. Assessments include physical function, pain, sleep, anxiety, mood, satisfaction and adherence to the treatment, and number of visits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the intervention will be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) and Behavioral Interventions Using Technology (BIT) frameworks will be used to evaluate implementation. This study is expected to produce a co-created evidence-based digital intervention for pediatric chronic pain and a roadmap for successful implementation. ClinicalTrials.gov (registered on 26 June 2023: https://clinicaltrials.gov/study/NCT05917626). Contributions to the literature The implementation of digital health interventions has two major gaps: (1) adherence to treatment is suboptimal, and (2) the process of making the interventions available to the end-user in a sustainable way is often unsuccessful.In this study, we expect that assessing users' needs and co-designing an intervention with them will improve adherence.Documenting the implementation process from the project inception and integrating the results into an implementation framework will allow for replication and extension in different contexts.This study will increase the knowledge about implementation in a vulnerable population: adolescents with chronic pain without access to in-person multidisciplinary pain care.

Therapist and supervisor perspectives about two train-the-trainer implementation strategies in schools: A qualitative study.

Train-the-trainer (TT) implementation strategies (in which designated clinicians are trained to then train others in an intervention) are promising approaches to support mental health clinician use of evidence-based interventions in school contexts. However, there is little evidence to date examining clinicians' perceptions of the acceptability and feasibility of TT strategies, or comparing clinicians' perceptions of different types of TT strategies. The current study was conducted as part of a larger hybrid effectiveness-implementation trial, in which school-based therapists and supervisors received one of two different types of implementation support to implement cognitive behavioral therapy (CBT) groups for anxiety: TT (i.e., initial training for therapists and supervisors) or enhanced TT (TT+; i.e., initial training for therapists and supervisors, and ongoing external consultation for supervisors). We used applied thematic analysis to compare qualitative interview transcripts from 28 therapist interviews and 33 supervisor interviews from therapists and supervisors who received TT or TT+ support and report themes that were similar and different across the two groups. Most themes were similar across the TT and TT+ conditions: therapists and supervisors in both conditions perceived the group anxiety intervention as acceptable and viewed supervision as acceptable, helpful, and feasible. Therapists and supervisors in both conditions had mixed impressions of the contextual appropriateness of the group anxiety intervention, and some reported logistical challenges with weekly supervision. Some unique themes were identified among the TT+ condition, including supervisors experiencing professional growth, and therapists and supervisors perceiving supervision as critically important and enjoyable. These results suggest that TT implementation support, using a model in which an internal supervisor receives initial training and then provides ongoing supervision, is acceptable and feasible to support a group CBT intervention in schools. The results also highlight additional benefits that therapists and supervisors perceived when supervisors received ongoing consultation. The clinical trial from which these data were derived was registered at ClinicalTrials.gov (https://clinicaltrials.gov/) prior to the time of first patient enrollment. The registration number is: NCT02651402.

A machine learning approach to improve implementation monitoring of family-based preventive interventions in primary care.

Evidence-based parenting programs effectively prevent the onset and escalation of child and adolescent behavioral health problems. When programs have been taken to scale, declines in the quality of implementation diminish intervention effects. Gold-standard methods of implementation monitoring are cost-prohibitive and impractical in resource-scarce delivery systems. Technological developments using computational linguistics and machine learning offer an opportunity to assess fidelity in a low burden, timely, and comprehensive manner. In this study, we test two natural language processing (NLP) methods [i.e., Term Frequency-Inverse Document Frequency (TF-IDF) and Bidirectional Encoder Representations from Transformers (BERT)] to assess the delivery of the Family Check-Up 4 Health (FCU4Health) program in a type 2 hybrid effectiveness-implementation trial conducted in primary care settings that serve primarily Latino families. We trained and evaluated models using 116 English and 81 Spanish-language transcripts from the 113 families who initiated FCU4Health services. We evaluated the concurrent validity of the TF-IDF and BERT models using observer ratings of program sessions using the COACH measure of competent adherence. Following the Implementation Cascade model, we assessed predictive validity using multiple indicators of parent engagement, which have been demonstrated to predict improvements in parenting and child outcomes. Both TF-IDF and BERT ratings were significantly associated with observer ratings and engagement outcomes. Using mean squared error, results demonstrated improvement over baseline for observer ratings from a range of 0.83-1.02 to 0.62-0.76, resulting in an average improvement of 24%. Similarly, results demonstrated improvement over baseline for parent engagement indicators from a range of 0.81-27.3 to 0.62-19.50, resulting in an approximate average improvement of 18%. These results demonstrate the potential for NLP methods to assess implementation in evidence-based parenting programs delivered at scale. Future directions are presented. NCT03013309 ClinicalTrials.gov.