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Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study.

ABSTRACT: BACKGROUND:Tobacco, alcohol and opioid misuse are associated with substantial morbidity and mortality among people with HIV (PWH). Despite existence of evidence-based counseling and medications for addiction, these treatments are infrequently offered in HIV clinics. The Working with HIV clinics to adopt Addiction Treatment using Implementation Facilitation (WHAT-IF?) study was conducted to address this implementation challenge. The study's goals were to conduct a formative evaluation of barriers to and facilitators of implementing addiction treatment for PWH followed by an evaluation of the impact of Implementation Facilitation (IF) on promoting adoption of addiction treatments and clinical outcomes. METHODS:The study was conducted at four HIV clinics in the northeast United States, using a hybrid type 3 effectiveness-implementation stepped wedge design and guided by the Promoting Action on Research Implementation in Health Services Research (PARiHS) framework. A mixed-methods approach was used to identify evidence, context, and facilitation-related barriers to and facilitators of integration of addiction treatments into HIV clinics and to help tailor IF for each clinic. An evaluation was then conducted of the impact of IF on implementation outcomes, including provision of addiction treatment (primary outcome), organizational and clinician and staff readiness to adopt addiction treatment, and changes in organizational models of care used to deliver addiction treatment. The evaluation also included IF's impact on effectiveness outcomes, specifically HIV-related outcomes among patients eligible for addiction treatment. CONCLUSIONS:Results will generate important information regarding the impact of IF as a reproducible strategy to promote addiction treatment in HIV clinics.

SUBMITTER: Edelman EJ

PROVIDER: S-EPMC7511156 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study.

Edelman E Jennifer EJ Dziura James J Esserman Denise D Porter Elizabeth E Becker William C WC Chan Philip A PA Cornman Deborah H DH Rebick Gabriel G Yager Jessica J Morford Kenneth K Muvvala Srinivas B SB Fiellin David A DA

Contemporary clinical trials 20200923

<h4>Background</h4>Tobacco, alcohol and opioid misuse are associated with substantial morbidity and mortality among people with HIV (PWH). Despite existence of evidence-based counseling and medications for addiction, these treatments are infrequently offered in HIV clinics. The Working with HIV clinics to adopt Addiction Treatment using Implementation Facilitation (WHAT-IF?) study was conducted to address this implementation challenge. The study's goals were to conduct a formative evaluation of ...[more]

PMID: 32976995

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Project description:ImportanceMedications for addiction treatment (MAT) are inconsistently offered in HIV clinics.ObjectiveTo evaluate the impact of implementation facilitation (hereafter referred to as "facilitation"), a multicomponent implementation strategy, on increasing provision of MAT for opioid use disorder (MOUD), alcohol use disorder (MAUD), and tobacco use disorder (MTUD).Design, setting, and participantsConducted from July 26, 2016, through July 25, 2020, the Working with HIV Clinics to adopt Addiction Treatment using Implementation Facilitation (WHAT-IF?) study used an unblinded, stepped wedge design to sequentially assign each of 4 HIV clinics in the northeastern US to cross over from control (ie, baseline practices) to facilitation (ie, intervention) and then evaluation and maintenance periods every 6 months. Participants were adult patients with opioid, alcohol, or tobacco use disorder. Data analysis was performed from August 2020 to September 2022.InterventionsMulticomponent facilitation.Main outcomes and measuresOutcomes, assessed using electronic health record data, were provision of MAT among patients with opioid, alcohol, or tobacco use disorder during the evaluation (primary outcome) and maintenance periods compared with the control period.ResultsAmong 3647 patients, the mean (SD) age was 49 (12) years, 1814 (50%) were Black, 781 (22%) were Hispanic, and 1407 (39%) were female; 121 (3%) had opioid use disorder, 126 (3%) had alcohol use disorder, and 420 (12%) had tobacco use disorder. Compared with the control period, there was no increase in provision of MOUD with facilitation during the evaluation period (243 patients [27%; 95% CI, 22%-32%] vs 135 patients [28%; 95% CI, 22%-35%]; P = .59) or maintenance period (198 patients [29%; 95% CI, 22%-36%]; P = .48). The change in provision of MAUD from the control period to the evaluation period was not statistically significant (251 patients [8%; 95% CI, 5%-12%] vs 112 patients [13%; 95% CI, 8%-21%]; P = .11); however, the difference increased and became significant during the maintenance period (180 patients [17%; 95% CI, 12%-24%]; P = .009). There were significant increases in provision of MTUD with facilitation during both the evaluation (810 patients [33%; 95% CI, 30%-36%] vs 471 patients [40%; 95% CI, 36%-45%]; P = .005) and maintenance (643 patients [38%; 95% CI, 34%-41%]; P = .047) periods.Conclusions and relevanceIn this randomized clinical trial, facilitation led to increased provision of MTUD, delayed improvements in MAUD, and no improvements in MOUD in HIV clinics. Enhanced strategies, potentially including clinic and patient incentives, especially for MOUD, may be needed to further increase provision of MAT in HIV clinics.Trial registrationClinicalTrials.gov Identifier: NCT02907944.

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:BackgroundSchools present a context with great potential for the implementation of psychosocial evidence-based practices. Cognitive behavioral therapy (CBT) is an evidence-based practice that has been found to be very effective in treating anxiety in various community settings, including schools. Friends for Life (FRIENDS) is an efficacious group CBT protocol for anxiety. Unfortunately, evidence-based practices for anxiety are seldom employed in under-resourced urban schools, because many treatment protocols are not a good fit for the urban school context or the population, existing behavioral health staff do not receive adequate training or support to allow them to implement the treatment with fidelity, or school districts do not have the resources to contract with external consultants. In our prior work, we adapted FRIENDS to create a more culturally sensitive, focused, and feasible CBT protocol for anxiety disorders (CBT for Anxiety Treatment in Schools (CATS)).Methods/designThe aim of this 5-year study is to evaluate both the effectiveness of CATS for urban public schools compared to the original FRIENDS as well as compare the implementation strategies (train-the-trainer vs. train-the-trainer + ongoing consultation) by conducting a three-arm, parallel group, type 2 hybrid effectiveness-implementation trial in 18 K-8 urban public schools. We will also assess the cost-effectiveness and the mediators and moderators of fidelity. Ninety therapists, 18 agency supervisors, and 360 children will participate. The interactive systems framework for dissemination and implementation guides the training and support procedures for therapists and supervisors.DiscussionThis study has the potential to demonstrate that agency therapists and supervisors who have had little to no prior exposure to evidence-based practices (EBPs) can implement an anxiety disorder EBP with fidelity. Comparisons of the implementation strategies would provide large urban mental health systems with data to make decisions about the adoption of EBPs.Trial registrationClinicalTrials.gov, NCT02651402.

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:BackgroundIntegrating mental health providers into primary care clinics improves access to and outcomes of mental health care. In the Veterans Health Administration (VA) Primary Care Mental Health Integration (PCMHI) program, mental health providers are co-located in primary care clinics, but the implementation of this model is challenging outside large VA medical centers, especially for rural clinics without full mental health staffing. Long wait times for mental health care, little collaboration between mental health and primary care providers, and sub-optimal outcomes for rural veterans could result. Telehealth could be used to provide PCMHI to rural clinics; however, the clinical effectiveness of the tele-PCMHI model has not been tested. Based on evidence that implementation facilitation is an effective implementation strategy to increase uptake of PCMHI when delivered on-site at larger VA clinics, it is hypothesized that this strategy may also be effective with regard to ensuring adequate uptake of the tele-PCMHI model at rural VA clinics.MethodsThis study is a hybrid type 2 pragmatic effectiveness-implementation trial of tele-PCMHI in six sites over 24 months. Tele-PCMHI, which will be delivered by clinical staff available in routine care settings, will be compared to usual care. Fidelity to the care model will be monitored but not controlled. We will use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to evaluate the patient-level clinical effectiveness of tele-PCMHI in rural VA clinics and also to evaluate the fidelity to and outcomes of the implementation strategy, implementation facilitation. The proposed study will employ a stepped-wedge design in which study sites sequentially begin implementation in three steps at 6-month intervals. Each step will include (1) a 6-month period of implementation planning, followed by (2) a 6-month period of active implementation, and (3) a final period of stepped-down implementation facilitation.DiscussionThis study will evaluate the effectiveness of PCMHI in a novel setting and via a novel method (clinical video telehealth). We will test the feasibility of using implementation facilitation as an implementation strategy to deploy tele-PCMHI in rural VA clinics.Trial registrationClinicalTrials.gov registration number NCT02713217 . Registered on 18 March 2016.

Project description:BackgroundMotivational interviewing (MI) has been shown to effectively improve self-management for youth living with HIV (YLH) and has demonstrated success across the youth HIV care cascade-currently, the only behavioral intervention to do so. Substantial barriers prevent the effective implementation of MI in real-world settings. Thus, there is a critical need to understand how to implement evidence-based practices (EBPs), such as MI, and promote behavior change in youth HIV treatment settings as risk-taking behaviors peak during adolescence and young adulthood.ObjectiveThis study aims to describe the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) protocol of a tailored MI (TMI) implementation-effectiveness trial (ATN 146 TMI) to scale up an EBP in multidisciplinary adolescent HIV settings while balancing flexibility and fidelity. This protocol is part of the Scale It Up program described in this issue.MethodsThis study is a type 3, hybrid implementation-effectiveness trial that tests the effect of TMI on fidelity (MI competency and adherence to program requirements) while integrating findings from two other ATN protocols described in this issue-ATN 153 Exploration, Preparations, Implementation, Sustainment and ATN 154 Cascade Monitoring. ATN 153 guides the mixed methods investigation of barriers and facilitators of implementation, while ATN 154 provides effectiveness outcomes. The TMI study population consists of providers at 10 adolescent HIV care sites around the United States. These 10 clinics are randomly assigned to 5 blocks to receive the TMI implementation intervention (workshop and trigger-based coaching guided by local implementation teams) utilizing the dynamic wait-listed controlled design. After 12 months of implementation, a second randomization compares a combination of internal facilitator coaching with the encouragement of communities of practice (CoPs) to CoPs alone. Participants receive MI competency assessments on a quarterly basis during preimplementation, during the 12 months of implementation and during the sustainment period for a total of 36 months. We hypothesize that MI competency ratings will be higher among providers during the TMI implementation phase compared with the standard care phase, and successful implementation will be associated with improved cascade-related outcomes, namely undetectable viral load and a greater number of clinic visits among YLH.ResultsParticipant recruitment began in August 2017 and is ongoing. As of mid-May 2018, TMI has 150 active participants.ConclusionsThis protocol describes the underlying theoretical framework, study design, measures, and lessons learned for TMI, a type 3, hybrid implementation-effectiveness trial, which has the potential to scale up MI and improve patient outcomes in adolescent HIV settings.Trial registrationClinicalTrials.gov NCT03681912; https://clinicaltrials.gov/ct2/show/NCT03681912 (Archived by WebCite at http://www.webcitation.org/754oT7Khx).International registered report identifier (irrid)DERR1-10.2196/11200.

Project description:BackgroundPatients with opioid use disorder (OUD) frequently present to the emergency department (ED) after overdose, or seeking treatment for general medical conditions, their addiction, withdrawal symptoms, or complications of injection drug use, such as soft tissue infections. ED-initiated buprenorphine has been shown to be effective in increasing patient engagement in treatment compared with brief intervention with a facilitated referral or referral alone. However, adoption into practice has lagged behind need. To address this implementation challenge, we are evaluating the impact of implementation facilitation (IF) on the adoption of ED-initiated buprenorphine for OUD into practice.MethodsThis protocol describes a study that is being conducted through the National Institute on Drug Abuse's Center for the Clinical Trials Network. A hybrid type III effectiveness-implementation study design is used to evaluate the effectiveness of a standard educational dissemination strategy versus IF on implementation (primary) and effectiveness (secondary) outcomes in four urban, academic EDs. Sites start with a standard 60-min "Grand Rounds" educational intervention describing the prevalence of ED patients with OUD, the evidence for opioid agonist treatment and for innovative interventions with ED-initiated buprenorphine; followed by a 1-year baseline evaluation period. Using a modified stepped wedge design, sites are randomly assigned to the IF intervention which is guided by the Promoting Action on Research Implementation in Health Services (PARiHS) framework to assess evidence, context, and facilitation-related factors impacting the adoption of ED-initiated buprenorphine. During the 6 months of IF through the 1-year IF evaluation period, external facilitators work with local stakeholders to tailor and refine a bundle of activities to meet the site's needs. The primary analyses compare the baseline evaluation period to the IF evaluation period (n = 120 patients with untreated OUD enrolled during each period) on (1) rates of provision of ED-initiated buprenorphine by ED providers with referral for ongoing medication (implementation outcome) and (2) rates of patient engagement in addiction treatment on the 30th day after the ED visit (effectiveness outcome). Finally, we will perform a cost-effectiveness analysis (CEA) to determine if the effectiveness benefits are worth the additional costs.DiscussionResults will generate novel information regarding the impact of IF as a strategy to promote ED-initiated buprenorphine.Trial registrationClinicalTrials.gov NCT03023930 first posted 1/10/2017, https://clinicaltrials.gov/ct2/show/NCT03023930?term=0069&rank=1.

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Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study.

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Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study.

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