Project description:BackgroundBroadly disseminating and implementing evidence-based psychotherapies with high fidelity, particularly cognitive behavioral therapy (CBT), has proved challenging for many health-care systems, including the Department of Veterans Affairs, especially in primary care settings such as small or remote clinics. A computer-based tool (based on the coordinated anxiety learning and management (CALM) program) was designed to support primary care-based mental health providers in delivering CBT. The objectives of this study are to modify the CALM tool to meet the needs of mental health clinicians in veterans affairs (VA) community-based outpatient clinics (CBOCs) and rural "veterans", use external facilitation to implement CBT and determine the effect of the CALM tool versus a manualized version of CALM to improve fidelity to the CBT treatment model, and conduct a needs assessment to understand how best to support future implementation of the CALM tool in routine care.Methods/designFocus groups will inform the redesign of the CALM tool. Mental health providers at regional VA CBOCs; CBT experts; VA experts in implementation of evidence-based mental health practices; and veterans with generalized anxiety disorder, panic disorder, social anxiety disorder, posttraumatic stress disorder, "with or without" depression will be recruited. A hybrid type III design will be used to examine the effect of receiving CBT training plus either the CALM tool or a manual version of CALM on treatment fidelity. External facilitation will be used as the overarching strategy to implement both CBT delivery methods. Data will also be collected on symptoms of the targeted disorders. To help prepare for the future implementation of the CALM tool in VA CBOCs, we will perform an implementation need assessment with mental health providers participating in the clinical trial and their CBOC directors.DiscussionThis project will help inform strategies for delivering CBT with high fidelity in VA CBOCs to veterans with anxiety disorders and PTSD with or without depression. If successful, results of this study could be used to inform a national rollout of the CALM tool in VA CBOCs including providing recommendations for optimizing the adoption and sustained use of the computerized CALM tool among mental health providers in this setting.Trial registrationClinicalTrials.gov, NCT02488551.

Project description:BackgroundThe USA is undergoing a suicide epidemic for its youngest Veterans (18-to-34-years-old) as their suicide rate has almost doubled since 2001. Veterans are at the highest risk during their first-year post-discharge, thus creating a "deadly gap." In response, the nation has developed strategies that emphasize a preventive, universal, and public health approach and embrace the value of community interventions. The three-step theory of suicide suggests that community interventions that reduce reintegration difficulties and promote connectedness for Veterans as they transition to civilian life have the greatest likelihood of reducing suicide. Recent research shows that the effectiveness of community interventions can be enhanced when augmented by volunteer and certified sponsors (1-on-1) who actively engage with Veterans, as part of the Veteran Sponsorship Initiative (VSI).Method/designThe purpose of this randomized hybrid type 2 effectiveness-implementation trial is to evaluate the implementation of the VSI in six cities in Texas in collaboration with the US Departments of Defense, Labor and Veterans Affairs, Texas government, and local stakeholders. Texas is an optimal location for this large-scale implementation as it has the second largest population of these young Veterans and is home to the largest US military installation, Fort Hood. The first aim is to determine the effectiveness of the VSI, as evidenced by measures of reintegration difficulties, health/psychological distress, VA healthcare utilization, connectedness, and suicidal risk. The second aim is to determine the feasibility and potential utility of a stakeholder-engaged plan for implementing the VSI in Texas with the intent of future expansion in more states. The evaluators will use a stepped wedge design with a sequential roll-out to participating cities over time. Participants (n=630) will be enrolled on military installations six months prior to discharge. Implementation efforts will draw upon a bundled implementation strategy that includes strategies such as ongoing training, implementation facilitation, and audit and feedback. Formative and summative evaluations will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework and will include interviews with participants and periodic reflections with key stakeholders to longitudinally identify barriers and facilitators to implementation.DiscussionThis evaluation will have important implications for the national implementation of community interventions that address the epidemic of Veteran suicide. Aligned with the Evidence Act, it is the first large-scale implementation of an evidence-based practice that conducts a thorough assessment of TSMVs during the "deadly gap."Trial registrationClinicalTrials.gov ID number: NCT05224440 . Registered on 04 February 2022.

Project description:BackgroundThe number of children diagnosed with autism has rapidly outpaced the capacities of many public school systems to serve them, especially under-resourced, urban school districts. The intensive nature of evidence-based autism interventions, which rely heavily on one-to-one delivery, has caused schools to turn to computer-assisted interventions (CAI). There is little evidence regarding the feasibility, effectiveness, and implementation of CAI in public schools. While CAI has the potential to increase instructional time for students with autism, it may also result in unintended consequences such as reduction in the amount of interpersonal (as opposed to computerized) instruction students receive. The purpose of this study is to test the effectiveness of one such CAI-TeachTown-its implementation, and its effects on teachers' use of other evidence-based practices.MethodsThis study protocol describes a type II hybrid cluster randomized effectiveness-implementation trial. We will train and coach 70 teachers in autism support classrooms in one large school district in the use of evidence-based practices for students with autism. Half of the teachers then will be randomly selected to receive training and access to TeachTown: Basics, a CAI for students with autism, for the students in their classrooms. The study examines: (1) the effectiveness of TeachTown for students with autism; (2) the extent to which teachers implement TeachTown the way it was designed (i.e., fidelity); and (3) whether its uptake increases or reduces the use of other evidence-based practices.DiscussionThis study will examine the implementation of new technology for children with ASD in public schools and will be the first to measure the effectiveness of CAI. As importantly, the study will investigate whether adding a new technology on top of existing practices increases or decreases their use. This study presents a unique method to studying both the implementation and exnovation of evidence-based practices for children with autism in school settings.Trial registrationNCT02695693 . Retrospectively registered on July 8, 2016.

Project description:BACKGROUND: Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. METHODS: This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n?=?200) or usual care (n?=?120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity. CONCLUSIONS: Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice. TRIAL REGISTRATION: NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772.

Project description:BackgroundInsomnia affects almost one in four military service members and veterans. The first-line recommended treatment for insomnia is cognitive-behavioral therapy for insomnia (CBTI). CBTI is typically delivered in-person or online over one-to-four sessions (brief versions) or five-to-eight sessions (standard versions) by a licensed doctoral or masters-level clinician with extensive training in behavioral sleep medicine. Despite its effectiveness, CBTI has limited scalability. Three main factors inhibit access to and delivery of CBTI including restricted availability of clinical expertise; rigid, resource-intensive treatment formats; and limited capacities for just-in-time monitoring and treatment personalization. Digital technologies offer a unique opportunity to overcome these challenges by providing scalable, personalized, resource-sensitive, adaptive, and cost-effective approaches for evidence-based insomnia treatment.MethodsThis is a hybrid type 3 implementation-effectiveness randomized trial using a scalable evidence-based digital health software platform, NOCTEM™'s Clinician-Operated Assistive Sleep Technology (COAST™). COAST includes a clinician portal and a patient app, and it utilizes algorithms that facilitate detection of sleep disordered patterns, support clinical decision-making, and personalize sleep interventions. The first aim is to compare three clinician- and system-centered implementation strategies on the reach, adoption, and sustainability of the COAST digital platform by offering (1) COAST only, (2) COAST plus external facilitation (EF: assistance and consultation to providers by NOCTEM's sleep experts), or (3) COAST plus EF and internal facilitation (EF/IF: assistance/consultation to providers by NOCTEM's sleep experts and local champions). The second aim is to quantify improvements in insomnia among patients who receive behavioral sleep care via the COAST platform. We hypothesize that reach, adoption, and sustainability and the magnitude of improvements in insomnia will be superior in the EF and EF/IF groups relative to the COAST-only group.DiscussionDigital health technologies and machine learning-assisted clinical decision support tools have substantial potential for scaling access to insomnia treatment. This can augment the scalability and cost-effectiveness of CBTI without compromising patient outcomes. Engaging providers, stakeholders, patients, and decision-makers is key in identifying strategies to support the deployment of digital health technologies that can promote quality care and result in clinically meaningful sleep improvements, positive systemic change, and enhanced readiness and health among service members.Trial registrationClinicalTrials.gov NCT04366284 . Registered on 28 April 2020.

Project description:BackgroundOpioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim).MethodsA 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff's extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff's intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline).DiscussionThere is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators.Trial registrationThis clinical trial has been registered with clinicaltrials.gov (NCT03931174). Registered April 30, 2019. https://clinicaltrials.gov/ct2/show/NCT03931174?term=project+mimic&draw=2&rank=1.

Project description:INTRODUCTION:Two of the most acute and feared complications in type 1 diabetes (T1D) are hypoglycaemia and severe hypoglycaemia (SH). While impaired awareness of hypoglycaemia (IAH) can lead to SH with cognitive and motivational barriers implicated, the available education does not integrate behavioural change techniques to address these. A novel Hypoglycaemia Awareness Restoration Programme despite optimised care (HARPdoc) is currently being tested against an established blood glucose awareness training (BGAT) within a parallel, two-arm, group randomised, blinded trial (with its own protocol; NCT02940873) with adults with T1D whose problems with hypoglycaemia and SH have persisted despite otherwise optimised insulin management. While both programmes are aimed at reducing hypoglycaemia, SH and IAH, it is the former that integrates behavioural change techniques.The aim of the current (implementation) study is to evaluate delivery of both HARPdoc and BGAT and explore associations between implementation outcomes and trial endpoints; as well as to develop an evidence-based implementation blueprint to guide implementation, sustainment and scale-up of the effective programmes. METHODS AND ANALYSIS:Guided by the implementation science tools, frameworks, methods and principles, the current study was designed through a series of focus groups (n=11) with the key intervention stakeholders (n=28)-including (1) individuals with lived experience of T1D, IAH and a pilot version of the HARPdoc (n=6) and (2) diabetes healthcare professionals (n=22). A mixed-methods approach will be used throughout. Stakeholder engagement has underpinned study design and materials to maximise relevance, feasibility and impact. ETHICS AND DISSEMINATION:The protocol has been reviewed and received ethical approval by the Harrow Research Ethics Committee (18/LO/1020; 240752) on 1 October 2018. The findings will be submitted to a peer-reviewed journal and presented at scientific meetings. TRIAL REGISTRATION NUMBER:NCT02940873; Pre-results.

Project description:BackgroundEvidence shows that using the AWARD (Ask, Warn, Advise, Refer, Do-it-again) model with service-learning model in youngsters may be an appropriate strategy to refer young smokers for early smoking cessation services. Therefore this study aims to promote smoking cessation by training secondary school students as anti-smoke ambassadors (ASAs) with increased knowledge, skills and self-efficacy on smoking cessation and AWARD model using service-learning model.MethodsA cluster randomized controlled trial will be conducted in 14 secondary schools in Hong Kong. Also, a hybrid type 1 effectiveness-implementation design with the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework will be adopted. For the intervention group, participants (n = 184) will attend a 3-hour training workshop, followed by hands-on sessions supervised by trained nursing students, then a 6-month smoker referral competition and an award presentation ceremony. The control group (n = 184) will only attend the 3-hour training workshop. The research assistant will contact participants at the start and the end of training program, and at 3, 6, and 12 months after the end of the training program by telephone to complete a set of questionnaires. Participating secondary schools, participating nursing students, ASAs, and responsible organizational staff will be randomly invited for a one-to-one semi-structured interview. The primary outcome will be the number of smokers who referred by secondary school students. Descriptive statistics, mixed between-within-subjects ANOVA, logistic regressions, and content analysis will be used.DiscussionThis study will bridge the gap in existing literature by determining the effectiveness and exploring facilitators and barriers in implementing our intervention with the use of the AWARD model and service-learning model in training young people to refer smokers to anti-smoke organizations in the real-world. This can enhance our community capacity and enable youngsters to take a proactive role to support smoking cessation.Trial registrationClinicalTrials.gov, NCT05897346. Registered on 11 May 2023.

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Design of a dual randomized trial in a type 2 hybrid effectiveness—implementation study

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