Development and Usability of an Endoscopist Report Card Assessing ERCP Quality.

BACKGROUND AND AIMS: Audit and feedback (A&F) for endoscopic retrograde cholangiopancreatography (ERCP) is relatively understudied despite the demonstrated effectiveness of A&F for endoscopic procedures such as colonoscopy. Endoscopist 'report cards' are one A&F tool. We aimed to develop an ERCP report card and assess its appropriateness, acceptability and feasibility through usability testing. METHODS: A prototype report card was designed using a combination of published quality indicators and established predictors of adverse events (AE). Exploratory analyses from a prospective multi-center registry were performed to further identify novel and/or understudied parameters for possible inclusion. Semi-structured interviews with ERCP endoscopists were conducted and framework analysis performed. Validated post-interview usability instruments were administered. Feedback was incorporated to create a final report card. RESULTS: The report card included domains of technical parameters, AE rates/prevention, and patient-reported experience measures (PREMs). Qualitative feedback was positive, with respondents agreeing with inclusion of relevant content in most domains. Post-interview instruments revealed adequate appropriateness and acceptability. PREMs were felt by respondents to be poorly actionable and were replaced with appropriateness of indication and fluoroscopy usage parameters in the final report card. Concerns were raised regarding the feasibility of implementation due to reliance on difficult-to-obtain granular intraprocedural data. CONCLUSIONS: We designed and tested an ERCP report card that has potential to be an effective A&F intervention for endoscopists in clinical practice. Though feasibility of data capture and implementation are currently limitations, advances in video recording and artificial intelligence technologies could accelerate widespread adoption of such a tool.

Testing effectiveness and implementation of a standardized approach to sexual dysfunction screening among adolescent and young adult-aged survivors of childhood cancer: A type I hybrid, mixed methods trial protocol.

BACKGROUND: Approximately 20-50% of adolescent and young adult-aged childhood cancer survivors (AYA-CCS) experience sexual dysfunction (SD), although this healthcare need is widely underrecognized. Previous research from both AYA-CCS patients and their providers report that SD needs are unaddressed despite patient desires for SD discussions to be incorporated as part of their care. Patients and providers agree that standardized use of a patient-reported outcome measure may facilitate SD discussions; an SD screening approach was developed with patient and provider input. This study will measure the effectiveness of a standardized SD screening intervention and assess implementation outcomes and multilevel barriers and facilitators to guide future research. METHODS: This multi-site, mixed methods, type 1 effectiveness-implementation hybrid trial will be evaluated using a pre-post design (NCT05524610). The trial will enroll 86 AYA-CCS (ages 15-39) from two cancer centers in the United States. The SD intervention consists of core fundamental functions with a "menu" of intervention options to allow for flexibility in delivery and tailoring in variable contexts. Effectiveness of the intervention on facilitating SD communication will be measured through patient surveys and clinical data; multivariable logistic regression will be used for the binary outcome of self-reported SD screening, controlling for patient-level predictors. Implementation outcomes will be assessed using mixed methods (electronic health record abstraction, patient and provider surveys, and provider interviews. Quantitative and qualitative findings will be merged using a joint display to understand factors affecting intervention success. IMPLICATIONS: Identification and treatment of SD in AYA-CCS is an important and challenging quality of life concern. The type 1 hybrid design will facilitate rapid translation from research to practice by testing the effects of the intervention while simultaneously identifying multilevel barriers and facilitators to real-world implementation. This approach will inform future testing and dissemination of the SD screening intervention.

Testing effectiveness and implementation of a standardized approach to sexual dysfunction screening among adolescent and young adult-aged survivors of childhood cancer: A type I hybrid, mixed methods trial protocol: Effectiveness of sexual dysfunction screening among AYA cancer survivors: a study protocol.

Background: Approximately 20-50% of adolescent and young adult-aged childhood cancer survivors (AYA-CCS) experience sexual dysfunction (SD), although this healthcare need is widely underrecognized. Previous research from both AYA-CCS patients and their providers report that SD needs are unaddressed despite patient desires for SD discussions to be incorporated as part of their care. Patients and providers agree that standardized use of a patient-reported outcome measure may facilitate SD discussions; an SD screening approach was developed with patient and provider input. This study will measure the effectiveness of a standardized SD screening intervention and assess implementation outcomes and multilevel barriers and facilitators to guide future research. Methods: This multi-site, mixed methods, type 1 effectiveness-implementation hybrid trial will be evaluated using a pre-post design (NCT05524610). The trial will enroll 86 AYA-CCS (ages 15-39) from two cancer centers in the United States. The SD intervention consists of core fundamental functions with a "menu" of intervention options to allow for flexibility in delivery and tailoring in variable contexts. Effectiveness of the intervention on facilitating SD communication will be measured through patient surveys and clinical data; multivariable logistic regression will be used for the binary outcome of self-reported SD screening, controlling for patient-level predictors. Implementation outcomes will be assessed using mixed methods (electronic health record abstraction, patient and provider surveys, and provider interviews. Quantitative and qualitative findings will be merged using a joint display to understand factors affecting intervention success. Implications: Identification and treatment of SD in AYA-CCS is an important and challenging quality of life concern. The type 1 hybrid design will facilitate rapid translation from research to practice by testing the effects of the intervention while simultaneously identifying multilevel barriers and facilitators to real-world implementation. This approach will inform future testing and dissemination of the SD screening intervention.

A Digital Intervention to Improve Skin Self-Examination Among Survivors of Melanoma: Protocol for a Type-1 Hybrid Effectiveness-Implementation Randomized Trial.

BACKGROUND: Although melanoma survival rates have improved in recent years, survivors remain at risk of recurrence, second primary cancers, and keratinocyte carcinomas. The National Comprehensive Cancer Network recommends skin examinations by a physician every 3 to 12 months. Regular thorough skin self-examinations (SSEs) are recommended for survivors of melanoma to promote the detection of earlier-stage, thinner melanomas, which are associated with improved survival and lower treatment costs. Despite their importance, less than a quarter of survivors of melanoma engage in SSEs. OBJECTIVE: Previously, our team developed and evaluated a web-based, fully automated intervention called mySmartSkin (MSS) that successfully improved SSE among survivors of melanoma. Enhancements were proposed to improve engagement with and outcomes of MSS. The purpose of this paper is to describe the rationale and methodology for a type-1 hybrid effectiveness-implementation randomized trial evaluating the enhanced MSS versus control and exploring implementation outcomes and contextual factors. METHODS: This study will recruit from state cancer registries and social media 300 individuals diagnosed with cutaneous malignant melanoma between 3 months and 5 years after surgery who are currently cancer free. Participants will be randomly assigned to either enhanced MSS or a noninteractive educational web page. Surveys will be collected from both arms at baseline and at 3, 6, 12, and 18 months to assess measures of intervention engagement, barriers, self-efficacy, habit, and SSE. The primary outcome is thorough SSE. The secondary outcomes are the diagnosis of new or recurrent melanomas and sun protection practices. RESULTS: Multilevel modeling will be used to examine whether there are significant differences in survivor outcomes between MSS and the noninteractive web page over time. Mixed methods will evaluate reach, adoption, implementation (including costs), and potential for maintenance of MSS, as well as contextual factors relevant to those outcomes and future scale-up. CONCLUSIONS: This trial has the potential to improve outcomes in survivors of melanoma. If MSS is effective, the results could guide its implementation in oncology care and nonprofit organizations focused on skin cancers. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/52689.

Provider perspectives and recommendations on standardized sexual function screening intervention in adolescent/young adult oncology patients.

BACKGROUND: Sexual function (SF) concerns are common among adolescent and young adult (AYA) cancer survivors, are underrecognized and undertreated. This study sought AYA oncology provider input on the implementation of an SF screening tool to address this unmet need. PROCEDURE: Semi-structured interviews were completed with oncology providers (n = 25) who care for AYAs at a single institution. Interviews sought to understand barriers to addressing SF, elicit perspectives on use of an established screening tool, and obtain recommendations for SF screening intervention development and implementation. Interviews were developed using the Consolidated Framework for Implementation Research (CFIR); thematic analysis-guided interpretation. RESULTS: AYA oncology providers were in favor of using an SF screening tool, but confirmed previously identified barriers and implementation considerations within multiple CFIR domains, including concerns about privacy, patient comfort, provider buy-in, provider knowledge, resource needs, and workflow/capacity constraints. They identified numerous strategies to address barriers through screening intervention design and implementation approaches. For example, provider buy-in could be optimized through education, availability of clinical resources, creation of a dedicated sexual healthcare team, provider engagement in intervention development, and leadership involvement. CONCLUSIONS: Development and implementation of an effective SF screening intervention is necessary to improve diagnosis and treatment of sexual dysfunction, with the ultimate goal of improving sexual health-related quality of life in AYA cancer survivors. AYA oncology providers identified numerous intervention and implementation design strategies for the development and implementation of an SF screening intervention, which must be integrated with patient recommendations.

RE-AIM implementation outcomes and service outcomes: what's the connection? results of a cross-sectional survey.

BACKGROUND: Implementation science and health services outcomes research each focus on many constructs that are likely interrelated. Both fields would be informed by increased understanding of these relationships. However, there has been little to no investigation of the relationships between implementation outcomes and service outcomes, despite general acknowledgement that both types of outcomes are important in the pathway to individual and population health outcomes. Given the lack of objective data about the links between implementation and service outcomes, an initial step in elucidating these relationships is to assess perceptions of these relationships among researchers and practitioners in relevant fields. The purpose of this paper is to assess perceived relationships between Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework outcomes and service outcomes, testing five a priori hypotheses about which perceived relationships may be strongest. METHODS: A cross-sectional online survey was administered to a convenience sample of implementation scientists, health services researchers, and public health and medical practitioners from a variety of settings. Respondents provided information on their discipline, training, practice and research settings, and levels of experience in health service outcomes research, implementation science, and the RE-AIM framework. Next, they rated perceived relationships between RE-AIM and service outcomes. Repeated measures analysis of variance were used to test a priori hypotheses. Exploratory analyses assessed potential differences in mean ratings across groups of respondents categorized by discipline, setting, and levels of implementation science, health services, and RE-AIM experience. RESULTS: Surveys were completed by 259 respondents, most of whom were employed in academic and medical settings. The majority were doctoral-level researchers and educators or physicians. Reported levels of experience with implementation research, health services research, and the RE-AIM framework varied. The strongest perceived relationships overall were between Implementation/Fidelity and Effectiveness (as a service outcome); Maintenance and Efficiency; Reach and Equity; Adoption and Equity; Implementation/Adaptation and Patient-Centeredness; Adoption and Patient-Centeredness; and Implementation/Fidelity and Safety. All but one of the a priori hypotheses were supported. No significant differences in ratings of perceived relationships were observed among subgroups of respondents. CONCLUSIONS: This study is an initial step in developing conceptual understanding of the links between implementation outcomes, health services outcomes, and health outcomes. Our findings on perceived relationships between RE-AIM and services outcomes suggest some areas of focus and identify several areas for future research to advance both implementation science and health services research toward common goals of improving health outcomes.

Randomized-controlled trial of a whole-family obesity prevention and treatment intervention designed for low-income Hispanic families: HeLP the healthy living program.

BACKGROUND: Low-income Hispanic families face marked disparities in obesity, but interventions for obesity prevention and treatment have rarely been designed with this population as a focus. Hispanic culture is characterized by Familism, a value that prioritizes familial respect, cooperation, and togetherness. We describe the rationale and design of a trial of the Healthy Living Program (HeLP), a bilingual whole-family behavioral obesity prevention and treatment intervention designed around the value Familism and addressing food insecurity. METHODS/DESIGN: This two-group randomized comparative effectiveness trial will compare the effects of HeLP versus a primary care counseling intervention (Recommended Treatment of Obesity in Primary Care, or RTOP) on decreasing body mass index (BMI; kg/m2) in Hispanic children 2-16 years of age with obesity and preventing BMI increase among siblings without obesity. 164 families per arm will be recruited from primary care practices. Families randomized to HeLP will participate in 12 two-hour sessions, followed by booster sessions. HeLP sessions include family meals and instruction in parenting skills, nutrition, culinary skills, fitness, and mindfulness delivered at community recreation centers by bilingual health educators and athletic trainers. Families randomized to RTOP will be offered individual visits in primary care every 3 months throughout the 18-month follow-up period. Secondary outcomes include changes to objectively measured child fitness, the home environment related to nutrition, physical activity, and media usage, food insecurity, child eating behaviors, quality of life, parent BMI and waist circumference, and implementation outcomes. DISCUSSION: This protocol paper describes the rationale and planned methods for the comparative effectiveness trial. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT05041855 (6/13/2023).

Universal, School-Based Mental Health Program Implemented Among Racially and Ethnically Diverse Youth Yields Equitable Outcomes: Building Resilience for Healthy Kids.

Although suicide is a leading cause of mortality among racial and ethnic minority youth, limited data exists regarding the impact of school-based mental health interventions on these populations, specifically. A single-arm pragmatic trial design was utilized to evaluate the equity of outcomes of the universal, school-based mental health coaching intervention, Building Resilience for Healthy Kids. All sixth-grade students at an urban middle school were invited to participate. Students attended six weekly sessions with a health coach discussing goal setting and other resilience strategies. 285 students (86%) participated with 252 (88%) completing both pre- and post-intervention surveys. Students were a mean age of 11.4 years with 55% identifying as girls, 69% as White, 13% as a racial minority, and 18% as Hispanic. Racial minority students exhibited greater improvements in personal and total resilience compared to White students, controlling for baseline scores.

Facebook Intervention for Young-Onset Melanoma Survivors and Families: Protocol for a Randomized Controlled Trial.

BACKGROUND: Individuals diagnosed with melanoma before the age of 40 years (young-onset melanoma survivors) and their first-degree relatives (FDRs) are a growing population at risk for developing recurrent melanoma or new melanomas. Regular surveillance using clinical skin examination (CSE) and skin self-examination (SSE) and engagement in preventive behaviors including sun protection are recommended. Given the growing population of survivors and their families who are at increased risk, it is surprising that no behavioral interventions have been developed and evaluated to improve risk-reduction behaviors. OBJECTIVE: We describe the rationale and methodology for a randomized controlled trial evaluating the efficacy of a Facebook intervention providing information, goal setting, and peer support to increase CSE, SSE, and sun protection for young-onset melanoma survivors and their FDRs. METHODS: Overall, 577 survivors and 577 FDRs will be randomly assigned to either the Young Melanoma Family Facebook Group or the Melanoma Family Healthy Lifestyle Facebook Group condition. Participants will complete measures of CSE, SSE, and sun protection, and mediator measures of attitudes and beliefs before and after the intervention. The primary aim is to evaluate the impact of the Young Melanoma Family Facebook intervention versus the Melanoma Family Healthy Lifestyle Facebook intervention on CSE, SSE frequency and comprehensiveness, and sun protection among FDRs. The secondary aims examine the efficacy of the Young Melanoma Family Facebook intervention on survivors' SSE frequency and comprehensiveness and sun protection behaviors and mechanisms of intervention efficacy for intervention impact on FDR and survivor outcomes. The exploratory aim is to evaluate the efficacy of the 2 interventions on perceived stress, physical activity, and healthy eating. RESULTS: This project was funded by the National Institutes of Health (R01CA221854). The project began in May 2018, and recruitment started in January 2019. We anticipate completing enrollment by November 2023. Power calculations recommended a sample size of 577 survivors and 577 FDRs. Multilevel modeling treating family as the upper-level sampling unit and individual as the lower-level sampling unit will be the primary data analytic approach. Fixed effect predictors in these models will include condition, role, sex, all 2- and 3-way interactions, and covariates. CONCLUSIONS: The Young Melanoma Family Facebook intervention aims to improve primary and secondary skin cancer prevention for young-onset melanoma survivors and their family members. The intervention's delivery via a popular, freely available social media platform increases its impact because of the potential for dissemination in many contexts. If efficacious, this program could be disseminated by dermatologist practices, public health or nonprofit organizations focused on melanoma, and existing melanoma and skin cancer Facebook groups, thereby expanding its reach. This project will produce a content library of posts and a moderation guide for others. TRIAL REGISTRATION: ClinicalTrials.gov NCT03677739; https://clinicaltrials.gov/ct2/show/NCT03677739. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39640.

Unmeasured factors are associated with the use of completion lymph node dissection (CLND) in melanoma.

BACKGROUND: Completion lymph node dissection (CLND) was the standard treatment for patients with melanoma with positive sentinel lymph nodes (SLN) until 2017 when data from the DeCOG-SLT and MLST-2 randomized trials challenged the survival benefit of this procedure. We assessed the contribution of patient, tumor and facility factors on the use of CLND in patients with surgically resected Stage III melanoma. METHODS: Using the National Cancer Database, patients who underwent surgical excision and were found to have a positive SLN from 2012 to 2017 were included. A multivariable mixed-effects logistic regression model with a random intercept for the facility was used to determine the effect of patient, tumor, and facility variables on the risk of CLND. Reference effect measures (REMs) were used to compare the contribution of contextual effects (unknown facility variables) versus measured variables on the variation in CLND use. RESULTS: From 2012 to 2017, the overall use of CLND decreased from 59.9% to 26.5% (p < 0.0001). Overall, older patients and patients with government-based insurance were less likely to undergo CLND. Tumor factors associated with a decreased rate of CLND included primary tumor location on the lower limb, decreasing depth, and mitotic rate <1. However, the contribution of contextual effects to the variation in CLND use exceeded that of the measured facility, tumor, time, and patient variables. CONCLUSIONS: There was a decrease in CLND use during the study period. However, there is still high variability in CLND use, mainly driven by unmeasured contextual effects.

The Impact of a Universal Mental Health Intervention on Youth with Elevated Negative Affectivity: Building Resilience for Healthy Kids.

Objective: In response to the rise in mental health needs among youth, a school-based resilience intervention was implemented for sixth graders at an urban middle school. The goal of this analysis is to examine improvements in key mental health parameters among students who endorsed negative affectivity at baseline. Method: A total of 285 11-12-year-olds (72% white, 18% Hispanic, 55% female) participated in a single-arm, non-randomized 6-week 1:1 school-based coaching intervention, Healthy Kids. Youth completed validated surveys at baseline and 6-week follow-up assessing depression/anxiety symptoms, bullying, self-efficacy, academic pressure, grit, and resilience. Participants were determined to have elevated negative affectivity if they reported mild-to-severe symptoms for both depression and anxiety symptoms. General linear models examined differences between groups for each mental health parameter, as well as change in outcomes from baseline to follow-up. Results: A third of participants (38%) at baseline endorsed negative affectivity. Youth who endorsed negative affectivity were more often female (71% vs 29%; p < 0.001) and identified as victims of cyberbullying (25% vs 8%; p < 0.001). Youth with baseline negative affectivity scored lower for self-efficacy (total 70.5 vs 86.8; p < 0.0001). Baseline negative affectivity was a significant moderator for change in mental health parameters. Post-intervention, those who endorsed baseline negative affectivity, medium effect sizes were observed for self-efficacy (g = 0.6; 95%CI 0.3, 0.9; p < 0.001) and anxiety symptoms (g = - 0.70; 95%CI - 1.0, - 0.4; p < 0.001). Among all youth, there were significant medium intervention effects in resilience (g = 0.5; 95%CI 0.3, 0.7; p < 0.001) and self-efficacy (g = 0.7; 95%CI 0.4, 0.9; p < 0.001). Conclusions: A universal resiliency program may improve self-efficacy and symptoms of anxiety among youth experiencing negative affectivity, while improving resilience and self-efficacy among all youth. Our findings suggest a universal school-based coaching program benefits all youth, while also specifically targeting the needs of youth with negative affectivity who are most at risk for mental health concerns.

Behavioral Parent Training for Families With Young Deaf or Hard of Hearing Children Followed in Hearing Health Care.

PURPOSE: It is well established that individuals with a communication disability, including being deaf or hard of hearing (DHH), experience inequities in health services and outcomes. These inequities extend to DHH children's access to psychosocial evidence-based interventions (EBIs). Behavioral parent training is an EBI that can be used to improve caregiver and child outcomes. Despite being supported by decades of effectiveness research, this EBI is rarely accessed by, or studied with, caregivers of DHH children. The purpose of this article is to describe a program of stakeholder-engaged research adapting and assessing behavioral parent training with caregivers of young DHH children followed in hearing health care, aimed at reducing inequities in access to this EBI. METHOD: The first section briefly summarizes the literature on disruptive behavior problems in young children, with a focus on preschool-age DHH children. The evidence base for behavioral parent training is described. Next, the gaps in knowledge and practice regarding disruptive behaviors among DHH children are highlighted, and the potential integration of behavioral parent training into the standard of care for this population is proposed. CONCLUSIONS: Young DHH children who use hearing aids and/or cochlear implants experience disruptive behavior problems at rates at least as high as typically hearing children, but their access to EBIs is limited, and behavioral parent training programs tailored to this population have not been rigorously tested. Caregivers and hearing health care service providers affirm the potential benefits of behavioral parent training and were partners in adapting this EBI. This research highlights several principles and approaches essential for reducing inequities and improving the quality of life not only for DHH children and their families but also for individuals with communication disabilities more broadly: engagement of key stakeholders in research, collaboration across disciplines, and using implementation science methods and models to design for implementation, dissemination, and sustainment. Presentation Video: https://doi.org/10.23641/asha.21215900.

Implementation Science: Increasing the Public Health Impact of Audiology Research.

PURPOSE: Implementation science aims to facilitate the use of evidence-based programs, practices, and policies in routine care settings. In audiology, as in other health disciplines, there is a persistent research-to-practice gap. Improving the adoption, reach, implementation, and sustainment of effective interventions in audiology would increase their public health impact, ensuring that all individuals needing hearing health care services could benefit from innovations and evidence-based best practices. This tutorial provides an introductory overview of implementation science relevant to the field of audiology, including Internet-based practices and interventions. METHOD: Major concepts and themes of implementation science are presented, including implementation outcomes, implementation science frameworks, implementation strategies, current topics in implementation science, and study design considerations. Recent publications in audiology are highlighted to illustrate implementation science concepts and themes. The relevance of each topic to the use of evidence-based programs, practices, and policies in audiology is highlighted with reference to recent research in the field. CONCLUSIONS: Challenges in the widespread delivery of evidence-based audiological practices and interventions limit their public health impact. The application of implementation science principles and methods in audiology research, as demonstrated in other areas of health research, can increase our focus on ensuring that effective practices are widely available, accessible, equitable, and sustainable to improve the lives of those who need them.

Ranked determinants of telemedicine diabetic retinopathy screening performance in the United States primary care safety-net setting: an exploratory CART analysis.

BACKGROUND: Diabetic retinopathy (DR) is a leading cause of blindness worldwide, despite easy detection and effective treatment. Annual screening rates in the USA remain low, especially for the disadvantaged, which telemedicine-based DR screening (TDRS) during routine primary care has been shown to improve. Screening rates from such programs have varied, however, pointing to inconsistent implementation and unaddressed barriers. This work seeks to identify and prioritize modifiable barriers for targeted intervention. METHODS: In this final phase of an exploratory mixed-methods study, we developed, validated, and administered a 62-item survey to multilevel stakeholders involved with TDRS in primary care safety-net clinics. Survey items were aligned with previously identified determinants of clinic-level screening and mapped to the Consolidated Framework for Implementation Research (CFIR). Classification and Regression Tree (CART) analyses were used to identify and rank independent variables predictive of individual-level TDRS screening performance. RESULTS: Overall, 133 of the 341 invited professionals responded (39%), representing 20 safety-net clinics across 6 clinical systems. Respondents were predominately non-Hispanic White (77%), female (94%), and between 31 and 65 years of age (79%). Satisfaction with TDRS was high despite low self-reported screening rates. The most important screening determinants were: provider reinforcement of TDRS importance; explicit instructions by providers to staff; effective reminders; standing orders; high relative priority among routine diabetic measures; established TDRS workflows; performance feedback; effective TDRS champions; and leadership support. CONCLUSIONS: In this survey of stakeholders involved with TDRS in safety-net clinics, screening was low despite high satisfaction with the intervention. The best predictors of screening performance mapped to the CFIR constructs Leadership Engagement, Compatibility, Goals & Feedback, Relative Priority, Champions, and Available Resources. These findings facilitate the prioritization of implementation strategies targeting determinants of TDRS performance, potentially increasing its public health impact.

Communities Helping the Hearing of Infants by Reaching Parents (CHHIRP) through patient navigation: a hybrid implementation effectiveness stepped wedge trial protocol.

INTRODUCTION: As the most common neonatal sensory disorder in the USA, infant hearing loss has an incidence of 1.7 per 1000 births. The consequences of delayed diagnosis and failure to obtain timely intervention include significant communication impairment and negative socioeconomic effects. Early Hearing Detection and Intervention (EHDI) national standards dictate that all infants should be screened and diagnosed by 3 months of age and there is a need for interventions that promote adherence to timely diagnosis. Patient navigation (PN) has been shown to be efficacious to decrease non-adherence with infant hearing diagnostic care; however, PN has yet to be tested in diverse communities or implemented into real-world settings. METHODS AND ANALYSIS: The proposed research is a community-engaged, type 1 hybrid effectiveness-implementation trial of a PN intervention aimed at decreasing infant hearing diagnosis non-adherence after failed newborn hearing screening, delivered in state-funded EHDI clinics. Guided by our community advisory board and partners, we aim to (1) test the effectiveness of PN to decrease non-adherence to receipt of infant hearing diagnosis within 3 months after birth using a stepped-wedge trial design, (2) investigate implementation outcomes and factors influencing implementation and (3) determine the cost-effectiveness of PN from the perspective of third-party payers. The study will be conducted from April 2019 until March 2024. ETHICS AND DISSEMINATION: This protocol was approved by the University of Kentucky Institutional Review Board. Although all research involving human subjects contains some risk, there are no known serious risks anticipated from participating in this study. We will seek to disseminate our results in a systematic fashion to patients, key stakeholder, policymakers and the scientific community. Our results will impact the field by partnering with communities to inform the scale-up of this innovative patient supportive intervention to create efficient and effective EHDI programmes and maximise public health impact. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (Pre-results phase): NCT03875339.

Study Protocol: Type 1 Hybrid Effectiveness-Implementation Trial of a Behavioral Parent Training Intervention for Parents of Young Children Who Are Deaf or Hard of Hearing.

PURPOSE: Children who are deaf or hard of hearing (DHH) and who use hearing aids or cochlear implants are more likely than their peers with typical hearing to exhibit behavior problems. Although multiple evidence-based interventions for child behavior problems exist, they are rarely delivered to children who are DHH, and no rigorous randomized controlled trials have been conducted to determine their effects with this population. This protocol describes a study aiming to test the effectiveness of an evidence-based behavioral parent training intervention adapted for parents of young children who are DHH and simultaneously to assess key implementation outcomes and multilevel contextual factors influencing implementation. METHOD: The protocol for a Type 1 hybrid effectiveness-implementation trial of a behavioral parent training intervention for parents of young children who are DHH is presented, including details of the study design, participants, assessments, and analyses. Using a stakeholder-engaged, mixed-methods approach, we will test the effects of the intervention versus treatment as usual on parenting behaviors, child behaviors, and a range of secondary effectiveness outcomes, including adherence to using hearing aids and cochlear implants as well as measures of child speech and language. We will assess the acceptability, feasibility, fidelity, and costs of the intervention from the perspectives of peer coaches who deliver the intervention, hearing health care clinicians (including audiologists and speech-language pathologists), and administrators of programs serving young children who are DHH. CONCLUSIONS: Results of this trial will inform future efforts to close the gap between prevalence of behavioral problems in young children who are DHH and access to and use of evidence-based interventions to prevent and treat them. If effective, this intervention could be widely implemented using strategies informed by the findings of this study to benefit young children who are DHH and followed in hearing health care and their families.

Evaluation of multi-level barriers and facilitators in a large diabetic retinopathy screening program in federally qualified health centers: a qualitative study.

BACKGROUND: Recommended annual diabetic retinopathy (DR) screening for people with diabetes has low rates in the USA, especially in underserved populations. Telemedicine DR screening (TDRS) in primary care clinics could expand access and increase adherence. Despite this potential, studies have observed high variability in TDRS rates among clinics and over time, highlighting the need for implementation supports. Previous studies of determinants of TDRS focus on patients' perspectives, with few studies targeting upstream multi-level barriers and facilitators. Addressing this gap, this qualitative study aimed to identify and evaluate multi-level perceived determinants of TDRS in Federally Qualified Health Centers (FQHCs), to inform the development of targeted implementation strategies. METHODS: We developed a theory-based semi-structured interview tool based on the Consolidated Framework for Implementation Research (CFIR). We conducted 22 key informant interviews with professionals involved in TDRS (administrators, clinicians, staff). The interviews were audio-recorded and transcribed verbatim. Reported barriers and facilitators were organized into emergent themes and classified according to CFIR constructs. Constructs influencing TDRS implementation were rated for each study site and compared across sites by the investigators. RESULTS: Professionals identified 21 main barriers and facilitators under twelve constructs of the five CFIR domains. Several identified themes were novel, whereas others corroborated previous findings in the literature (e.g., lack of time and human resources, presence of a champion). Of the 21 identified themes, 13 were classified under the CFIR's Inner Setting domain, specifically under the constructs Compatibility and Available Resources. Themes under the Outer Setting domain (constructs External Incentives and Cost) were primarily perceived by administrators, whereas themes in other domains were perceived across all professional categories. Two Inner Setting (Leadership Engagement, Goals and Feedback) and two Process (Champion, Engaging) constructs were found to strongly distinguish sites with high versus low TDRS performance. CONCLUSIONS: This study classified barriers and facilitators to TDRS as perceived by administrators, clinicians, and staff in FQHCs, then identified CFIR constructs that distinguished high- and low-performance clinics. Implementation strategies such as academic detailing and collection and communication of program data and successes to leadership; engaging of stakeholders through involvement in implementation planning; and appointment of intervention champions may therefore improve TDRS implementation and sustainment in resource-constrained settings.

Adaptation of the NIDA Standard for delivery via Facebook with justice-involved women in rural Appalachia.

Background: Rising rates of intravenous drug use (IDU) in Appalachia have necessitated new approaches to providing risk-reduction interventions in a manner which will be acceptable and accessible to specific at-risk populations-particularly those with limited access to traditional evidence-based interventions. Using the ADAPT-ITT framework, the overall goal of this study is to adapt an evidence-based HIV prevention intervention-the NIDA Standard-to meet the needs of rural drug-using women post-release from jail. Methods: Through a series of focus groups with rural incarcerated women, theater-testing with members of the target population, and iterative refinements with topical experts, we aimed to identify potential adaptations to content and context to improve the fit, feasibility, and acceptability of the NIDA Standard for this population using social media. Results: Study findings confirmed the need for a preventive risk-reduction intervention targeting this population post-release. Adaptations to intervention content focused on adding, simplifying, and ensuring continuous access to content in the NIDA Standard. Adaptations to context included modifications to how the intervention will be delivered and by whom, including consideration of unique issues related to delivery using Facebook (such as privacy and confidentiality). Conclusion: The use of Facebook for delivery of the NIDA Standard may hold promise for increasing reach, acceptability, and feasibility of intervening with rural women with IDU released from jails, particularly when compared with traditional face-to-face sessions. With minor content adaptations to meet participant needs and preferences, plus multiple context adaptations to enhance accessibility and acceptability, the adapted NIDA Standard is intended to retain its original effectiveness while improving important implementation outcomes key to scaling-up and increasing public health impact. Plain Language Summary: What is known about the topic? Injection drug use rates are high in rural Appalachia, and new approaches are needed to reduce the risk of HIV and HCV among injection drug using women involved in the criminal justice system in this region. While there are effective risk-reduction interventions for HIV and HCV, they are difficult to deliver in rural Appalachia and do not reach the women who need them. What does this paper add? This study describes the use of a systematic approach to improve the "fit" of an evidence-based intervention-the NIDA Standard-with the preferences and perspectives of injection drug using women involved with the justice system, aided by guidance from experts in a specific risk-reduction intervention (the NIDA Standard) and delivery of interventions using Facebook. Changes to the intervention to increase its acceptability and accessibility in this population included shifting delivery of the intervention to a closed Facebook group rather than in person; use of brief videos rather than written text to provide information; use of trusted local women to provide information through videos and Facebook posts; and inclusion of local information on community risk factors and resources. Implications for practice, research, or policy: The use of Facebook for delivery of the NIDA Standard holds promise for increasing reach, acceptability, and feasibility of risk reduction among rural injection drug using women released from jails. Next steps include testing the feasibility, acceptability, and effects of the adapted intervention in several rural Appalachian counties.

The Psychometric Properties of the Minnesota Tobacco Withdrawal Scale Among Patients With Mental Illness.

BACKGROUND AND OBJECTIVES: Approximately 65% of psychiatric inpatients experience moderate-to-severe nicotine withdrawal (NW), a set of symptoms appearing within 24 hr after an abrupt cessation or reduction of use of tobacco-containing products in those using nicotine daily for at least a couple of weeks. The Minnesota Tobacco Withdrawal Scale (MTWS) is a widely used instrument for detecting NW. However, the psychometric properties of the MTWS have not previously been examined among patients with serious mental illness (SMI) undergoing tobacco-free hospitalization. The objective of this study was to examine the validity and reliability of the MTWS among patients with SMI during tobacco-free psychiatric hospitalization. METHODS: Reliability was tested by examining Cronbach's α and item analysis. Validity was examined through hypothesis testing and exploratory factor analysis (N = 255). RESULTS: The reliability analysis yielded a Cronbach's α coefficient of .763, an inter-item correlations coefficient of .393, and item-total correlations between .291 and .691. Hypothesis testing confirmed the construct validity of the MTWS, and an exploratory factor analysis yielded a unidimensional scale. CONCLUSION: The MTWS demonstrated adequate reliable and valid psychometric properties for measuring NW among patients with SMI. Nurses and other health-care professionals may use this instrument in clinical practice to identify patients with SMI experiencing NW. The MTWS is psychometrically sound for capturing NW during tobacco-free psychiatric hospitalization. Future research should examine the efficacy of the MTWS in measuring NW in this population over an extended period of hospitalization.