Dataset Information

Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

ABSTRACT: Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months.This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N?=?1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as < 50% patients receiving ? 3 EBP sessions) will be randomized to receive additional support from an EF or both EF/IF. Additionally, sites randomized to EF and still not responsive will be randomized to continue with EF alone or to receive EF/IF. The EF provides technical expertise in adapting LG in routine practice, whereas the on-site IF has direct reporting relationships to site leadership to support LG use in routine practice. The primary outcome is mental health-related quality of life; secondary outcomes include receipt of LG sessions, mood symptoms, implementation costs, and organizational change.This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF.ClinicalTrials.gov identifier: NCT02151331.

SUBMITTER: Kilbourne AM

PROVIDER: S-EPMC4189548 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

Kilbourne Amy M AM Almirall Daniel D Eisenberg Daniel D Waxmonsky Jeanette J Goodrich David E DE Fortney John C JC Kirchner JoAnn E JE Solberg Leif I LI Main Deborah D Bauer Mark S MS Kyle Julia J Murphy Susan A SA Nord Kristina M KM Thomas Marshall R MR

Implementation science : IS 20140930

<h4>Background</h4>Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator ...[more]

PMID: 25267385

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Project description:BackgroundTheory-based methods to support the uptake of evidence-based practices (EBPs) are critical to improving mental health outcomes. Implementation strategy costs can be substantial, and few have been rigorously evaluated. The purpose of this study is to conduct a cost-effectiveness analysis to identify the most cost-effective approach to deploying implementation strategies to enhance the uptake of Life Goals, a mental health EBP.MethodsWe used data from a previously conducted randomized trial to compare the cost-effectiveness of Replicating Effective Programs (REP) combined with external and/or internal facilitation among sites non-responsive to REP. REP is a low-level strategy that includes EBP packaging, training, and technical assistance. External facilitation (EF) involves external expert support, and internal facilitation (IF) augments EF with protected time for internal staff to support EBP implementation. We developed a decision tree to assess 1-year costs and outcomes for four implementation strategies: (1) REP only, (2) REP+EF, (3) REP+EF add IF if needed, (4) REP+EF/IF. The analysis used a 1-year time horizon and assumed a health payer perspective. Our outcome was quality-adjusted life years (QALYs). The economic outcome was the incremental cost-effectiveness ratio (ICER). We conducted deterministic and probabilistic sensitivity analysis (PSA).ResultsOur results indicate that REP+EF add IF is the most cost-effective option with an ICER of $593/QALY. The REP+EF/IF and REP+EF only conditions are dominated (i.e., more expensive and less effective than comparators). One-way sensitivity analyses indicate that results are sensitive to utilities for REP+EF and REP+EF add IF. The PSA results indicate that REP+EF, add IF is the optimal strategy in 30% of iterations at the threshold of $100,000/QALY.ConclusionsOur results suggest that the most cost-effective implementation support begins with a less intensive, less costly strategy initially and increases as needed to enhance EBP uptake. Using this approach, implementation support resources can be judiciously allocated to those clinics that would most benefit. Our results were not robust to changes in the utility measure. Research is needed that incorporates robust and relevant utilities in implementation studies to determine the most cost-effective strategies. This study advances economic evaluation of implementation by assessing costs and utilities across multiple implementation strategy combinations.Trial registrationClinicalTrials.gov Identifier: NCT02151331 , 05/30/2014.

Project description:BACKGROUND:Depressive and anxiety disorders affect 20-30% of school-age youth, most of whom do not receive adequate services, contributing to poor developmental and academic outcomes. Evidence-based practices (EBPs) such as cognitive behavioral therapy (CBT) can improve outcomes, but numerous barriers limit access among affected youth. Many youth try to access mental health services in schools, but school professionals (SPs: counselors, psychologists, social workers) are rarely trained adequately in CBT methods. Further, SPs face organizational barriers to providing CBT, such as lack of administrative support. Three promising implementation strategies to address barriers to school-based CBT delivery include (1) Replicating Effective Programs (REP), which deploys customized CBT packaging, didactic training in CBT, and technical assistance; (2) coaching, which extends training via live supervision to improve SP competence in CBT delivery; and (3) facilitation, which employs an organizational expert who mentors SPs in strategic thinking to promote self-efficacy in garnering administrative support. REP is a relatively low-intensity/low-cost strategy, whereas coaching and facilitation require additional resources. However, not all schools will require all three strategies. The primary aim of this study is to compare the effectiveness of a school-level adaptive implementation intervention involving REP, coaching, and facilitation versus REP alone on the frequency of CBT delivered to students by SPs and student mental health outcomes. Secondary and exploratory aims examine cost-effectiveness, moderators, and mechanisms of implementation strategies. METHODS:Using a clustered, sequential multiple-assignment, randomized trial (SMART) design, ??200 SPs from 100 schools across Michigan will be randomized initially to receive REP vs. REP+coaching. After 8 weeks, schools that do not meet a pre-specified implementation benchmark are re-randomized to continue with the initial strategy or to augment with facilitation. DISCUSSION:EBPs need to be implemented successfully and efficiently in settings where individuals are most likely to seek care in order to gain large-scale impact on public health. Adaptive implementation interventions hold the promise of providing cost-effective implementation support. This is the first study to test an adaptive implementation of CBT for school-age youth, at a statewide level, delivered by school staff, taking an EBP to large populations with limited mental health care access. TRIAL REGISTRATION:NCT03541317 -Registered on 29 May 2018 on ClinicalTrials.gov PRS.

Project description:BackgroundImproving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed.MethodsWe conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin).Results77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups.ConclusionsAn easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient.Trial registrationInformed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12.

Project description:BackgroundAmong people with serious mental illness (SMI), obesity contributes to increased cardiovascular disease (CVD) risk. The Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) randomized controlled trial (RCT) demonstrated that a behavioral intervention tailored to the needs of individuals with SMI results in clinically significant weight loss. While the research team delivered the ACHIEVE intervention in the trial, community mental health program staff are needed to deliver sessions to make scale-up feasible. Therefore, we adapted the ACHIEVE-Dissemination (ACHIEVE-D) curriculum to ease adoption and implementation in this setting. Designing and testing of implementation strategies is now needed to understand how to support ACHIEVE-D delivery by community mental health program staff coaches.ObjectiveThis study aims to conduct a pilot trial evaluating standard and enhanced implementation interventions to support the delivery of ACHIEVE-D in community mental health programs by examining effects on staff coaches' knowledge, self-efficacy, and delivery fidelity of the curriculum. We will also examine the effects on outcomes among individuals with SMI taking part in the curriculum.MethodsThe trial will be a cluster-randomized, 2-arm parallel pilot RCT comparing standard and enhanced implementation intervention at 6 months within community mental health programs. We will randomly assign programs to either the standard or enhanced implementation interventions. The standard intervention will combine multimodal training for coaches (real-time initial training via videoconference, ongoing virtual training, and web-based avatar-assisted motivational interviewing practice) with organizational strategy meetings to garner leadership support for implementation. The enhanced intervention will include all standard strategies, and the coaches will receive performance coaching. At each program, we will enroll staff to participate as coaches and clients with SMI to participate in the curriculum. Coaches will deliver the ACHIEVE-D curriculum to the clients with SMI. Primary outcomes will be coaches' knowledge, self-efficacy, and fidelity to the ACHIEVE-D curriculum. We will also examine the acceptability, feasibility, and appropriateness of ACHIEVE-D and the implementation strategies. Secondary outcomes among individuals with SMI will be weight and self-reported lifestyle behaviors.ResultsData collection started in March 2021, with completion estimated in March 2023. We recruited 9 sites and a total of 20 staff coaches and 72 clients with SMI. The expected start of data analyses will occur in March 2023, with primary results submitted for publication in April 2023.ConclusionsCommunity mental health programs may be an ideal setting for implementing an evidence-based weight management curriculum for individuals with SMI. This pilot study will contribute knowledge about implementation strategies to support the community-based delivery of such programs, which may inform future research that definitively tests the implementation and dissemination of behavioral weight management programs.Trial registrationClinicalTrials.gov NCT03454997; https://clinicaltrials.gov/ct2/show/NCT03454997.International registered report identifier (irrid)DERR1-10.2196/45802.

Project description:BackgroundWriting plays a central role in the communication of scientific ideas and is therefore a key aspect in researcher education, ultimately determining the success and long-term sustainability of their careers. Despite the growing popularity of e-learning, we are not aware of any existing study comparing on-line vs. traditional classroom-based methods for teaching scientific writing.MethodsForty eight participants from a medical, nursing and physiotherapy background from US and Brazil were randomly assigned to two groups (n = 24 per group): An on-line writing workshop group (on-line group), in which participants used virtual communication, google docs and standard writing templates, and a standard writing guidance training (standard group) where participants received standard instruction without the aid of virtual communication and writing templates. Two outcomes, manuscript quality was assessed using the scores obtained in Six subgroup analysis scale as the primary outcome measure, and satisfaction scores with Likert scale were evaluated. To control for observer variability, inter-observer reliability was assessed using Fleiss's kappa. A post-hoc analysis comparing rates of communication between mentors and participants was performed. Nonparametric tests were used to assess intervention efficacy.ResultsExcellent inter-observer reliability among three reviewers was found, with an Intraclass Correlation Coefficient (ICC) agreement = 0.931882 and ICC consistency = 0.932485. On-line group had better overall manuscript quality (p = 0.0017, SSQSavg score 75.3 +/- 14.21, ranging from 37 to 94) compared to the standard group (47.27 +/- 14.64, ranging from 20 to 72). Participant satisfaction was higher in the on-line group (4.3 +/- 0.73) compared to the standard group (3.09 +/- 1.11) (p = 0.001). The standard group also had fewer communication events compared to the on-line group (0.91 +/- 0.81 vs. 2.05 +/- 1.23; p = 0.0219).ConclusionOur protocol for on-line scientific writing instruction is better than standard face-to-face instruction in terms of writing quality and student satisfaction. Future studies should evaluate the protocol efficacy in larger longitudinal cohorts involving participants from different languages.

Dataset Information

Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

Publications

Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

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