Operationalizing Equity, Inclusion, and Access in Research Practice at a Large Academic Institution.

INTRODUCTION: Healthcare advances are hindered by underrepresentation in prospective research; sociodemographic, data, and measurement infidelity in retrospective research; and a paucity of guidelines surrounding equitable research practices. OBJECTIVE: The Joint Research Practices Working Group was created in 2021 to develop and disseminate guidelines for the conduct of inclusive and equitable research. METHODS: Volunteer faculty and staff from two research centers at the University of Pennsylvania initiated a multi-pronged approach to guideline development, including literature searches, center-level feedback, and mutual learning with local experts. RESULTS: We developed guidelines for (1) participant payment and incentives; (2) language interpretation and translation; (3) plain language in research communications; (4) readability of study materials; and (5) inclusive language for scientific communications. Key recommendations include (1) offer cash payments and multiple payment options to participants when required actions are completed; (2) identify top languages of your target population, map points of contact, and determine available interpretation and translation resources; (3) assess reading levels of materials and simplify language, targeting 6th- to 8th-grade reading levels; (4) improve readability through text formatting and style, symbols, and visuals; and (5) use specific, humanizing terms as adjectives rather than nouns. CONCLUSIONS: Diversity, inclusion, and access are critical values for research conduct that promotes justice and equity. These values can be operationalized through organizational commitment that combines bottom-up and top-down approaches and through partnerships across organizations that promote mutual learning and synergy. While our guidelines represent best practices at one time, we recognize that practices evolve and need to be evaluated continuously for accuracy and relevance. Our intention is to bring awareness to these critical topics and form a foundation for important conversations surrounding equitable and inclusive research practices.

Evaluating the implementation of a community health worker-delivered intervention integrating asthma care in West Philadelphia public schools.

OBJECTIVE: Schools are an important setting because students spend much of their time in school and engage in physical activity during the school day that could exacerbate asthma symptoms. Our objective is to understand the barriers and facilitators to implementing an experimental community health worker-delivered care coordination program for students with asthma within the context of the West Philadelphia Controls Asthma study. METHODS: Surveys (n = 256) and semi-structured interviews (n = 41) were completed with principals, teachers, nurses, and community health workers from 21 public and charter schools in West Philadelphia between January 2019 and September 2021. Survey participants completed the Evidence Based Practice Attitudes Scale, the Implementation Leadership Scale, and Organizational Climate Index. Semi-structured qualitative interview guides were developed, informed by the Consolidated Framework for Implementation Research. RESULTS: Participant responses indicate that they perceived benefits for schools and students related to the community health worker-based care coordination program. Several barriers and facilitators to implementing the program were noted, including challenges associated with incorporating the program into school nurse workflow, environmental triggers in the school environment, and challenges communicating with family members. An important facilitator that was identified was having supportive school administrators and staff who were engaged and saw the benefits of the program. CONCLUSIONS: This work can inform implementation planning for other locales interested in implementing community-based pediatric asthma control programs delivered by community health workers in schools.

Cluster Randomized Pragmatic Clinical Trial Testing Behavioral Economic Implementation Strategies to Improve Tobacco Treatment for Patients With Cancer Who Smoke.

PURPOSE: Few cancer centers systematically engage patients with evidence-based tobacco treatment despite its positive effect on quality of life and survival. Implementation strategies directed at patients, clinicians, or both may increase tobacco use treatment (TUT) within oncology. METHODS: We conducted a four-arm cluster-randomized pragmatic trial across 11 clinical sites comparing the effect of strategies informed by behavioral economics on TUT engagement during oncology encounters with cancer patients. We delivered electronic health record (EHR)-based nudges promoting TUT across four nudge conditions: patient only, clinician only, patient and clinician, or usual care. Nudges were designed to counteract cognitive biases that reduce TUT engagement. The primary outcome was TUT penetration, defined as the proportion of patients with documented TUT referral or a medication prescription in the EHR. Generalized estimating equations were used to estimate the parameters of a linear model. RESULTS: From June 2021 to July 2022, we randomly assigned 246 clinicians in 95 clusters, and collected TUT penetration data from their encounters with 2,146 eligible patients who smoke receiving oncologic care. Intent-to-treat (ITT) analysis showed that the clinician nudge led to a significant increase in TUT penetration versus usual care (35.6% v 13.5%; OR = 3.64; 95% CI, 2.52 to 5.24; P < .0001). Completer-only analysis (N = 1,795) showed similar impact (37.7% clinician nudge v 13.5% usual care; OR = 3.77; 95% CI, 2.73 to 5.19; P < .0001). Clinician type affected TUT penetration, with physicians less likely to provide TUT than advanced practice providers (ITT OR = 0.67; 95% CI, 0.51 to 0.88; P = .004). CONCLUSION: EHR nudges, informed by behavioral economics and aimed at oncology clinicians, appear to substantially increase TUT penetration. Adding patient nudges to the implementation strategy did not affect TUT penetration rates.

Equitable implementation of S.A.F.E. Firearm: A multi-method pilot study.

Attention to health equity is critical in the implementation of firearm safety efforts. We present our operationalization of equity-oriented recommendations in preparation for launch of a hybrid effectiveness-implementation trial focused on firearm safety promotion in pediatric primary care as a universal suicide prevention strategy. In Step 1 of our process, pre-trial engagement with clinican partners and literature review alerted us that delivery of a firearm safety program may vary by patients' medical complexity, race, and ethnicity. In Step 2, we selected the Health Equity Implementation Framework to inform our understanding of contextual determinants (i.e., barriers and facilitators). In Step 3, we leveraged an implementation pilot across 5 pediatric primary care clinics in 2 health system sites to study signals of inequities. Eligible well-child visits for 694 patients and 47 clinicians were included. Our results suggested that medical complexity was not associated with program delivery. We did see potential signals of inequities by race and ethnicity but must interpret with caution. Though we did not initially plan to examine differences by sex assigned at birth, we discovered that clinicians may be more likely to deliver the program to parents of male than female patients. Seven qualitative interviews with clinicians provided additional context. In Step 4, we interrogated equity considerations (e.g., why and how do these inequities exist). In Step 5, we will develop a plan to probe potential inequities related to race, ethnicity, and sex in the fully powered trial. Our process highlights that prospective, rigorous, exploratory work is vital for equity-informed implementation trials.

Stakeholder intention to engage in fidelity measurement methods in community mental health settings: A mixed methods study.

Background: The current gold standard for measuring fidelity (specifically, adherence) to cognitive behavioral therapy (CBT) is direct observation, a costly, resource-intensive practice that is not feasible for many community organizations to implement regularly. Recent research indicates that behavioral rehearsal (i.e., role-play between clinician and individual with regard to session delivery) and chart-stimulated recall (i.e., brief structured interview between clinician and individual about what they did in session; clinicians use the client chart to prompt memory) may provide accurate and affordable alternatives for measuring adherence to CBT in such settings, with behavioral rehearsal yielding greater correspondence with direct observation. Methods: Drawing on established causal theories from social psychology and leading implementation science frameworks, this study evaluates stakeholders' intention to use behavioral rehearsal and chart-stimulated recall. Specifically, we measured attitudes, self-efficacy, and subjective norms toward using each, and compared these factors across the two methods. We also examined the relationship between attitudes, self-efficacy, subjective norms, and intention to use each method. Finally, using an integrated approach we asked stakeholders to discuss their perception of contextual factors that may influence beliefs about using each method. These data were collected from community-based supervisors (n = 17) and clinicians (n = 66). Results: Quantitative analyses suggest moderately strong intention to use both methods across stakeholders. There were no differences in supervisors' or clinicians' attitudes, self-efficacy, subjective norms, or intention across methods. More positive attitudes and greater reported subjective norms were associated with greater reported intention to use either measure. Qualitative analyses identified participants' specific beliefs about using each fidelity measure in their organization, and results were organized using the Consolidated Framework for Implementation Research. Conclusions: Strategies are warranted to overcome or minimize potential barriers to using fidelity measurement methods and to further increase the strength of intention to use them.Plain Language Summary: The best way to measure fidelity, or how closely a clinician follows the protocol, to Cognitive Behavioral Therapy (CBT) is watching the session. This is an expensive practice that is not feasible for many community organizations to do regularly. Recent research indicates that behavioral rehearsal, or a role-play between the clinician and individual with regard to session delivery, and chart-stimulated recall, or a brief discussion between an individual and the clinician about what they did in session with the clinician having access to the chart to help them remember, may provide accurate and affordable alternatives for measuring fidelity to CBT. We just completed a study demonstrating that both methods are promising, with behavioral rehearsal offering scores that are the most similar to watching the session. Drawing on established theories from social psychology and leading implementation science frameworks, this study evaluates future supervisor and clinician motivation to use these fidelity measurement methods. Specifically, we measured supervisor (n = 17) and clinician (n = 66) attitudes, norms, self-efficacy, intentions, and anticipated barriers and facilitators to using each of these fidelity measurement tools. Quantitative and qualitative analyses suggest similar intention to use both methods, and concerns about barriers to using each method. Further research is warranted to minimize the burden associated with implementing fidelity measurement methods and deploying strategies to increase use.

Study protocol for a type III hybrid effectiveness-implementation trial of strategies to implement firearm safety promotion as a universal suicide prevention strategy in pediatric primary care.

BACKGROUND: Insights from behavioral economics, or how individuals' decisions and behaviors are shaped by finite cognitive resources (e.g., time, attention) and mental heuristics, have been underutilized in efforts to increase the use of evidence-based practices in implementation science. Using the example of firearm safety promotion in pediatric primary care, which addresses an evidence-to-practice gap in universal suicide prevention, we aim to determine: is a less costly and more scalable behavioral economic-informed implementation strategy (i.e., "Nudge") powerful enough to change clinician behavior or is a more intensive and expensive facilitation strategy needed to overcome implementation barriers? METHODS: The Adolescent and child Suicide Prevention in Routine clinical Encounters (ASPIRE) hybrid type III effectiveness-implementation trial uses a longitudinal cluster randomized design. We will test the comparative effectiveness of two implementation strategies to support clinicians' use of an evidence-based firearm safety practice, S.A.F.E. Firearm, in 32 pediatric practices across two health systems. All pediatric practices in the two health systems will receive S.A.F.E. Firearm materials, including training and cable locks. Half of the practices (k = 16) will be randomized to receive Nudge; the other half (k = 16) will be randomized to receive Nudge plus 1 year of facilitation to target additional practice and clinician implementation barriers (Nudge+). The primary implementation outcome is parent-reported clinician fidelity to the S.A.F.E Firearm program. Secondary implementation outcomes include reach and cost. To understand how the implementation strategies work, the primary mechanism to be tested is practice adaptive reserve, a self-report practice-level measure that includes relationship infrastructure, facilitative leadership, sense-making, teamwork, work environment, and culture of learning. DISCUSSION: The ASPIRE trial will integrate implementation science and behavioral economic approaches to advance our understanding of methods for implementing evidence-based firearm safety promotion practices in pediatric primary care. The study answers a question at the heart of many practice change efforts: which strategies are sufficient to support change, and why? Results of the trial will offer valuable insights into how best to implement evidence-based practices that address sensitive health matters in pediatric primary care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04844021 . Registered 14 April 2021.

Behavioral economic implementation strategies to improve serious illness communication between clinicians and high-risk patients with cancer: protocol for a cluster randomized pragmatic trial.

BACKGROUND: Serious illness conversations (SICs) are an evidence-based approach to eliciting patients' values, goals, and care preferences that improve patient outcomes. However, most patients with cancer die without a documented SIC. Clinician-directed implementation strategies informed by behavioral economics ("nudges") that identify high-risk patients have shown promise in increasing SIC documentation among clinicians. It is unknown whether patient-directed nudges that normalize and prime patients towards SIC completion-either alone or in combination with clinician nudges that additionally compare performance relative to peers-may improve on this approach. Our objective is to test the effect of clinician- and patient-directed nudges as implementation strategies for increasing SIC completion among patients with cancer. METHODS: We will conduct a 2 × 2 factorial, cluster randomized pragmatic trial to test the effect of nudges to clinicians, patients, or both, compared to usual care, on SIC completion. Participants will include 166 medical and gynecologic oncology clinicians practicing at ten sites within a large academic health system and their approximately 5500 patients at high risk of predicted 6-month mortality based on a validated machine-learning prognostic algorithm. Data will be obtained via the electronic medical record, clinician survey, and semi-structured interviews with clinicians and patients. The primary outcome will be time to SIC documentation among high-risk patients. Secondary outcomes will include time to SIC documentation among all patients (assessing spillover effects), palliative care referral among high-risk patients, and aggressive end-of-life care utilization (composite of chemotherapy within 14 days before death, hospitalization within 30 days before death, or admission to hospice within 3 days before death) among high-risk decedents. We will assess moderators of the effect of implementation strategies and conduct semi-structured interviews with a subset of clinicians and patients to assess contextual factors that shape the effectiveness of nudges with an eye towards health equity. DISCUSSION: This will be the first pragmatic trial to evaluate clinician- and patient-directed nudges to promote SIC completion for patients with cancer. We expect the study to yield insights into the effectiveness of clinician and patient nudges as implementation strategies to improve SIC rates, and to uncover multilevel contextual factors that drive response to these strategies. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04867850 . Registered on April 30, 2021. FUNDING: National Cancer Institute P50CA244690.

Rationale and protocol for a cluster randomized pragmatic clinical trial testing behavioral economic implementation strategies to improve tobacco treatment rates for cancer patients who smoke.

BACKGROUND: Routine evidence-based tobacco use treatment minimizes cancer-specific and all-cause mortality, reduces treatment-related toxicity, and improves quality of life among patients receiving cancer care. Few cancer centers employ mechanisms to systematically refer patients to evidence-based tobacco cessation services. Implementation strategies informed by behavioral economics can increase tobacco use treatment engagement within oncology care. METHODS: A four-arm cluster-randomized pragmatic trial will be conducted across nine clinical sites within the Implementation Science Center in Cancer Control Implementation Lab to compare the effect of behavioral economic implementation strategies delivered through embedded messages (or "nudges") promoting patient engagement with the Tobacco Use Treatment Service (TUTS). Nudges are electronic medical record (EMR)-based messages delivered to patients, clinicians, or both, designed to counteract known patient and clinician biases that reduce treatment engagement. We used rapid cycle approaches (RCA) informed by relevant stakeholder experiences to refine and optimize our implementation strategies and methods prior to trial initiation. Data will be obtained via the EMR, clinician survey, and semi-structured interviews with a subset of clinicians and patients. The primary measure of implementation is penetration, defined as the TUTS referral rate. Secondary outcome measures of implementation include patient treatment engagement (defined as the number of patients who receive FDA-approved medication or behavioral counseling), quit attempts, and abstinence rates. The semi-structured interviews, guided by the Consolidated Framework for Implementation Research, will assess contextual factors and patient and clinician experiences with the nudges. DISCUSSION: This study will be the first in the oncology setting to compare the effectiveness of nudges to clinicians and patients, both head-to-head and in combination, as implementation strategies to improve TUTS referral and engagement. We expect the study to (1) yield insights into the effectiveness of nudges as an implementation strategy to improve uptake of evidence-based tobacco use treatment within cancer care, and (2) advance our understanding of the multilevel contextual factors that drive response to these strategies. These results will lay the foundation for how patients with cancer who smoke are best engaged in tobacco use treatment and may lead to future research focused on scaling this approach across diverse centers. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04737031 . Registered 3 February 2021.

Adapting Safety Check as a Universal Suicide Prevention Strategy in Pediatric Primary Care.

OBJECTIVE: The presence of unlocked firearms in the home is associated with increased risk of suicide and unintentional injury in youth. We adapted an evidence-based program for promoting safe firearm storage, Safety Check, to enhance its acceptability as a universal suicide prevention strategy in pediatric primary care. METHODS: We applied ADAPT-ITT, an established adaptation framework, to guide iterative program adaptation with ongoing input from key stakeholders. The present study describes 2 phases of ADAPT-ITT: the Production phase (generating adaptations) and the Topical Experts phase (gathering stakeholder feedback on adaptations). After generating proposed program adaptations based on 3 inputs (stakeholder feedback collected in a prior study, the behavioral science literature, and best practices in pediatric medicine), we elicited feedback from stakeholders with firearm expertise. The adaptations included changes such as clarifying firearm ownership will not be documented in the medical record and offering follow-up reminders. We also crowdsourced feedback from 337 parents to select a new name and program logo. RESULTS: Saturation was reached with 9 stakeholders. Feedback confirmed the value of adaptations that: 1) considered context (eg, reason for ownership), 2) promoted parent autonomy in decision-making, and 3) ensured privacy. The most preferred program name was Suicide and Accident prevention through Family Education (SAFE) Firearm. CONCLUSIONS: Guided by an established adaptation framework that prioritized multistage stakeholder feedback, adaptations to the original Safety Check were deemed acceptable. We plan to test the SAFE Firearm program as a universal suicide prevention strategy in pediatric primary care via a hybrid effectiveness-implementation trial.

Perspectives from firearm stakeholders on firearm safety promotion in pediatric primary care as a suicide prevention strategy: a qualitative study.

The primary objective of the current study was to examine the perspective of firearm stakeholders, including firearm safety course instructors, members of law enforcement, and firearm retailers, with regard to the implementation of an evidence-based approach to firearm safety promotion, the Firearm Safety Check, as a universal suicide prevention strategy in pediatric primary care. Twelve firearm stakeholders participated in semi-structured interviews. Using an integrated analytic approach, several themes emerged from the interviews. With regard to acceptability of the intervention, participants generally found counseling caregivers to store firearms safely and the provision of firearm locking mechanisms to be acceptable, but expressed concern about screening for firearm ownership in health systems. Participants identified distinct roles of responsibility for firearm advocacy groups, firearm owners, healthcare clinicians, and caregivers with regard to the promotion and execution of safe firearm storage. Participants called for partnerships between healthcare systems and firearm stakeholders, and also identified potential threats to these partnerships, including lack of trust firearm owners may have in health systems and the government. Finally, participants suggested strategies for preventing firearm-related suicides. Findings support a growing body of literature suggesting the value in researchers, health systems, and firearm stakeholders partnering around a shared agenda of firearm safety promotion as a strategy to prevent suicide.

Transforming Mental Health Delivery Through Behavioral Economics and Implementation Science: Protocol for Three Exploratory Projects.

BACKGROUND: Efficacious psychiatric treatments are not consistently deployed in community practice, and clinical outcomes are attenuated compared with those achieved in clinical trials. A major focus for mental health services research is to develop effective and cost-effective strategies that increase the use of evidence-based assessment, prevention, and treatment approaches in community settings. OBJECTIVE: The goal of this program of research is to apply insights from behavioral economics and participatory design to advance the science and practice of implementing evidence-based practice (EBP) for individuals with psychiatric disorders across the life span. METHODS: Project 1 (Assisting Depressed Adults in Primary care Treatment [ADAPT]) is patient-focused and leverages decision-making heuristics to compare ways to incentivize adherence to antidepressant medications in the first 6 weeks of treatment among adults newly diagnosed with depression. Project 2 (App for Strengthening Services In Specialized Therapeutic Support [ASSISTS]) is provider-focused and utilizes normative pressure and social status to increase data collection among community mental health workers treating children with autism. Project 3 (Motivating Outpatient Therapists to Implement: Valuing a Team Effort [MOTIVATE]) explores how participatory design can be used to design organizational-level implementation strategies to increase clinician use of EBPs. The projects are supported by a Methods Core that provides expertise in implementation science, behavioral economics, participatory design, measurement, and associated statistical approaches. RESULTS: Enrollment for project ADAPT started in 2018; results are expected in 2020. Enrollment for project ASSISTS will begin in 2019; results are expected in 2021. Enrollment for project MOTIVATE started in 2018; results are expected in 2019. Data collection had begun for ADAPT and MOTIVATE when this protocol was submitted. CONCLUSIONS: This research will advance the science of implementation through efforts to improve implementation strategy design, measurement, and statistical methods. First, we will test and refine approaches to collaboratively design implementation strategies with stakeholders (eg, discrete choice experiments and innovation tournaments). Second, we will refine the measurement of mechanisms related to heuristics used in decision making. Third, we will develop new ways to test mechanisms in multilevel implementation trials. This trifecta, coupled with findings from our 3 exploratory projects, will lead to improvements in our knowledge of what causes successful implementation, what variables moderate and mediate the effects of those causal factors, and how best to leverage this knowledge to increase the quality of care for people with psychiatric disorders. TRIAL REGISTRATION: ClinicalTrials.gov NCT03441399; https://www.clinicaltrials.gov/ct2/show/NCT03441399 (Archived by WebCite at http://www.webcitation.org/74dRbonBD). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12121.

Acceptability and Use of Evidence-Based Practices for Firearm Storage in Pediatric Primary Care.

OBJECTIVE: Promoting safe firearm storage in pediatric primary care is one way to address youth suicide by firearm. The study objective was to determine the perspectives of primary care physicians (PCPs) and leaders of primary care practices regarding the acceptability and use of screening, counseling, and firearm locks-all components of an adapted evidence-based intervention known as the Firearm Safety Check. METHODS: In 2016, an online survey was conducted in two large US health systems. PCPs (n = 204) and leaders (n = 57) from 83 clinics were invited to participate. Respondents included 71 clinics (86%), 103 PCPs (50%), and 40 leaders (70%). Main outcomes included acceptability (6-point Likert scale, with higher scores indicating better acceptability) and use of the 3 intervention components (4-point Likert scale, with higher scores indicating greater use), as measured by an adapted validated instrument. RESULTS: Analyses were conducted in 2017. PCP acceptability of screening (mean = 4.28; standard deviation [SD] = 1.12) and counseling (mean = 4.56; SD = 0.89) were high, but acceptability for firearm lock provision was more neutral (mean = 3.78; SD = 1.16). Most PCPs endorsed sometimes screening (85%) and counseling (80%). Few PCPs offered firearm locks to caregivers (15%). Leaders reported consistent information. CONCLUSION: The acceptability of screening for firearms and safe storage counseling was high; both components were used commonly but not routinely. The acceptability of providing firearm locks was neutral, and use was rarely endorsed. This study provides important insights about areas of focus for future implementation efforts from policy and research perspectives.

Stakeholder Perspectives on Implementing a Firearm Safety Intervention in Pediatric Primary Care as a Universal Suicide Prevention Strategy: A Qualitative Study.

Importance: The rate of youth suicide has increased steadily over the past several decades due, in part, to an increase in suicide by firearm. Implementation of evidence-based approaches to increase safe firearm storage practices are important for reducing youth suicide. Objective: To assess the needs of stakeholders who would be affected by implementing an evidence-based approach to firearm safety promotion-Firearm Safety Check, which includes screening for the presence of firearms in the home, brief motivational interviewing-informed counseling regarding safe firearm storage, and provision of free firearm locks-in pediatric primary care settings. Design, Setting, and Participants: In this qualitative study, 58 stakeholders were interviewed over a 7-month period across 9 stakeholder groups from 2 large and diverse health systems. Participants included parents of youth; physicians; nurses and nurse practitioners; leaders of pediatric primary care practices, behavioral health, and quality improvement; system leaders; third-party payers; and members of national credentialing bodies. Data analysis were conducted from September 2017 to April 2018. Main Outcomes and Measures: Interview guides were informed by the Consolidated Framework for Implementation Research. An integrated analysis approach was used in which a priori attributes of interest were identified (Consolidated Framework for Implementation Research constructs, eg, intervention characteristics), and an inductive approach was used with regard to new themes that emerged. Results: A total of 58 stakeholders were interviewed (mean [SD] age, 48.38 [10.65] years; 27 men and 31 women). Stakeholders indicated that firearm safety promotion is a health system priority and reported favorable perceptions of the Firearm Safety Check approach for suicide prevention. The importance of leveraging existing infrastructures, such as electronic health record systems and brevity, were frequently noted. Distribution of firearm locks was endorsed as the most complicated component to implement. Conclusions and Relevance: By including multiple service system stakeholder perspectives, these results support the development of implementation strategies to change clinician, organization, and system behaviors around firearm safety promotion in pediatric primary care as a universal suicide prevention strategy.

Developing implementation strategies for firearm safety promotion in paediatric primary care for suicide prevention in two large US health systems: a study protocol for a mixed-methods implementation study.

INTRODUCTION: The promotion of safe firearm practices, or firearms means restriction, is a promising but infrequently used suicide prevention strategy in the USA. Safety Check is an evidence-based practice for improving parental firearm safety behaviour in paediatric primary care. However, providers rarely discuss firearm safety during visits, suggesting the need to better understand barriers and facilitators to promoting this approach. This study, Adolescent Suicide Prevention In Routine clinical Encounters, aims to engender a better understanding of how to implement the three firearm components of Safety Check as a suicide prevention strategy in paediatric primary care. METHODS AND ANALYSIS: The National Institute of Mental Health-funded Mental Health Research Network (MHRN), a consortium of 13 healthcare systems across the USA, affords a unique opportunity to better understand how to implement a firearm safety intervention in paediatric primary care from a system-level perspective. We will collaboratively develop implementation strategies in partnership with MHRN stakeholders. First, we will survey leadership of 82 primary care practices (ie, practices serving children, adolescents and young adults) within two MHRN systems to understand acceptability and use of the three firearm components of Safety Check (ie, screening, brief counselling around firearm safety and provision of firearm locks). Then, in collaboration with MHRN stakeholders, we will use intervention mapping and the Consolidated Framework for Implementation Research to systematically develop and evaluate a multilevel menu of implementation strategies for promoting firearm safety as a suicide prevention strategy in paediatric primary care. ETHICS AND DISSEMINATION: Study procedures have been approved by the University of Pennsylvania. Henry Ford Health System and Baylor Scott & White institutional review boards (IRBs) have ceded IRB review to the University of Pennsylvania IRB. Results will be submitted for publication in peer-reviewed journals.

A randomized trial to identify accurate and cost-effective fidelity measurement methods for cognitive-behavioral therapy: project FACTS study protocol.

BACKGROUND: This randomized trial will compare three methods of assessing fidelity to cognitive-behavioral therapy (CBT) for youth to identify the most accurate and cost-effective method. The three methods include self-report (i.e., therapist completes a self-report measure on the CBT interventions used in session while circumventing some of the typical barriers to self-report), chart-stimulated recall (i.e., therapist reports on the CBT interventions used in session via an interview with a trained rater, and with the chart to assist him/her) and behavioral rehearsal (i.e., therapist demonstrates the CBT interventions used in session via a role-play with a trained rater). Direct observation will be used as the gold-standard comparison for each of the three methods. METHODS/DESIGN: This trial will recruit 135 therapists in approximately 12 community agencies in the City of Philadelphia. Therapists will be randomized to one of the three conditions. Each therapist will provide data from three unique sessions, for a total of 405 sessions. All sessions will be audio-recorded and coded using the Therapy Process Observational Coding System for Child Psychotherapy-Revised Strategies scale. This will enable comparison of each measurement approach to direct observation of therapist session behavior to determine which most accurately assesses fidelity. Cost data associated with each method will be gathered. To gather stakeholder perspectives of each measurement method, we will use purposive sampling to recruit 12 therapists from each condition (total of 36 therapists) and 12 supervisors to participate in semi-structured qualitative interviews. DISCUSSION: Results will provide needed information on how to accurately and cost-effectively measure therapist fidelity to CBT for youth, as well as important information about stakeholder perspectives with regard to each measurement method. Findings will inform fidelity measurement practices in future implementation studies as well as in clinical practice. TRIAL REGISTRATION: NCT02820623 , June 3rd, 2016.