A Qualitative Study of Transportation-Related Barriers to HIV Care in South Carolina.

OBJECTIVES: Addressing structural barriers to care for people living with human immunodeficiency virus (HIV) in the southern United States is critical to increase rates of viral suppression and to reduce existing HIV disparities. This qualitative study aimed to describe transportation-related barriers experienced by people living with HIV in South Carolina, understand perceived effects of transportation vulnerability on HIV care, and explore strategies used by individuals to overcome transportation-related challenges. METHODS: We conducted semistructured interviews with 20 people living with HIV from South Carolina who were either reengaging in HIV care after a prolonged absence (>9 months) or in care but with a detectable viral load (ie, >200 copies/mL). All people living with HIV reported transportation vulnerability. A deductive/inductive approach was used to identify transportation-related barriers perceived to negatively affect HIV care. We also identified strategies and resources described by people living with HIV as helpful in addressing transportation challenges. RESULTS: Participants described a range of transportation-related barriers to HIV care, including lack of access to reliable, safe, and affordable transportation, as well as stigma due to HIV and socioeconomic statuses. These barriers were reported to negatively affect engagement in care and worsen both physical and mental health. Participants indicated flexible clinic policies and instrumental support from family and friends were useful in overcoming barriers. CONCLUSIONS: This study offers insight for the development of transportation interventions to improve equitable access to HIV care for people living with HIV in South Carolina. It also calls attention to the ways in which transportation vulnerability, HIV-related stigma, and disability status intersect to create unique challenges for some people living with HIV.

Implementation Science and Practice-Oriented Research: Convergence and Complementarity.

Implementation science is the scientific study of methods to promote the uptake of research findings and other evidence-based practices in routine care, with the goal of improving the quality and effectiveness of health services (Bauer et al., 2015). In addition to this common goal, practice-oriented psychotherapy research (and researchers) and implementation science (and scientists) share a common focus on the people and the places where treatment happens. Thus, there exists strong potential for combining these two approaches. In this article, we provide a primer on implementation science for psychotherapy researchers and highlight important areas and examples of convergence and complementarity between implementation science and practice-oriented psychotherapy research. Specifically, we (a) define and describe the core features of implementation science; (b) discuss similarities and areas of complementarity between implementation science and practice-oriented psychotherapy research; (c) discuss a case example that exemplifies the integration of implementation science and practice-oriented research; and (d) propose directions for future research and collaborations that leverage both implementation science and practice-oriented research.

A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans.

BACKGROUND: The unified protocol (UP) is a promising transdisgnostic treatment for emotional disorders; limited data exists with trauma-exposed populations. This study compared effectiveness of the UP, presented centered therapy (PCT), and treatment as usual (TAU) in trauma-exposed veterans presenting to routine care. METHOD: Trauma-exposed veterans with one or more emotional disorder diagnoses participated in a pilot hybrid-1 effectiveness/preimplementation study. Thirty-seven male and female veterans were randomized to one of three conditions. RESULTS: Multilevel growth curve modeling demonstrated improvement over time across conditions with large effect sizes (range: -2.15 to -3.32), with the UP demonstrating the greatest change. The between group effect sizes for reductions in number of comorbid diagnoses were medium to small and statistically significant (TAU and UP, d = 0.49, p = .056; TAU and PCT d = 0.18, p = .166, UP and PCT d = 0.31, p = .229). Only the UP led to a decrease in the number of comorbid diagnoses (d = -0.71). Psychosocial functioning varied by group, with slight increases in impairment in PCT and TAU, and medium effect size reduction in the UP. Only the UP exhibited significant decreases in self-reported anxiety and depression. Between group differences for UP and PCT were medium to large and statistically significant for depression across two measures (d = -0.72 to d = -1.40). CONCLUSIONS: This represents the first trial examining effectiveness of the UP, PCT, and TAU in trauma-exposed veterans. Despite a small sample, large effect size differences demonstrated promising advantages for the UP. Trial Registration Number: NCT02944994.

Correction to: The Association Between Clinician and Perceived Organizational Factors with Early Fidelity to Cognitive Processing Therapy for Posttraumatic Stress Disorder in a Randomized Controlled Implementation Trial.

The article "The Association Between Clinician and Perceived Organizational Factors with Early Fidelity to Cognitive Processing Therapy for Posttraumatic Stress Disorder in a Randomized Controlled Implementation Trial", written by Iris Sijercic, Jeanine E. M. Lane, Cassidy A. Gutner, Candice M. Monson and Shannon Wiltsey Stirman, was originally published electronically on the publisher's internet portal (currently SpringerLink) on 28 August 2019 with open access. With the author(s)' decision to step back from Open Choice, the copyright of the article changed on 30 August 2019 to © Springer Science+Business Media, LLC, part of Springer Nature 2019 and the article is forthwith distributed under the terms of copyright.

The Association Between Clinician and Perceived Organizational Factors with Early Fidelity to Cognitive Processing Therapy for Posttraumatic Stress Disorder in a Randomized Controlled Implementation Trial.

A common metric for determining implementation success is the measurement of clinician adherence to, and competence in, delivering a psychotherapy. The present study examined clinician and organizational factors as predictors of early adherence and competence among 78 clinicians delivering cognitive processing therapy (CPT), an evidence-based psychotherapy (EBP) for posttraumatic stress disorder, in a randomized controlled implementation trial. Results indicated that clinicians' willingness to adopt an EBP if required to do so was significantly associated with early adherence and competence in CPT delivery. Level of clinician education was significantly associated with early competence in delivering CPT. Organizational factors did not predict early adherence or competence. Implications of the findings are discussed.

Intimate Partner Violence Screening Programs in the Veterans Health Administration: Informing Scale-up of Successful Practices.

OBJECTIVES: Screening women for intimate partner violence (IPV) is increasingly expected in primary care, consistent with clinical prevention guidelines (e.g., United States Preventive Services Task Force). Yet, little is known about real-world implementation of clinical practices or contextual factors impacting IPV screening program success. This study identified successful clinical practices, and barriers to and facilitators of IPV screening program implementation in the Veterans Health Administration (VHA). DESIGN: Descriptive, qualitative study of a purposeful sample of 11 Veterans Affairs Medical Centers (VAMCs) categorized as early and late adopters of IPV screening programs within women's health primary care clinics. VAMCs were categorized based on performance measures collected by VHA operations partners. PARTICIPANTS: Thirty-two administrators and clinician key informants (e.g., Women's Health Medical Directors, IPV Coordinators, and physicians) involved in IPV screening program implementation decisions from six early- and five late-adopting sites nationwide. MAIN MEASURES: Participants reported on IPV screening and response practices, and contextual factors impacting implementation, in individual 1-h semi-structured phone interviews. Transcripts were analyzed using rapid content analysis with key practices and issues synthesized in profile summaries. Themes were identified and iteratively revised, utilizing matrices to compare content across early- and late-adopting sites. KEY RESULTS: Five successful clinical practices were identified (use of two specific screening tools for primary IPV screening and secondary risk assessment, multilevel resource provision and community partnerships, co-location of mental health/social work, and patient-centered documentation). Multilevel barriers (time/resource constraints, competing priorities and mounting responsibilities in primary care, lack of policy, inadequate training, and discomfort addressing IPV) and facilitators (engaged IPV champions, internal and external supports, positive feedback regarding IPV screening practices, and current, national attention to violence against women) were identified. CONCLUSIONS: Findings advance national efforts by highlighting successful clinical practices for IPV screening programs and informing strategies useful for enhancing their implementation within and beyond the VHA, ultimately improving services and women's health.

Stakeholder Preferences on Transdiagnostic Psychosocial Treatment for Trauma-Exposed Veterans.

While modular and transdiagnostic approaches may address implementation challenges, there remains limited investigation into the fit within large healthcare systems. The current study examines qualitative interviews from patients, clinicians and administrative stakeholders in the Veterans Administration about experiences with, and views of, the Unified Protocol (UP; Barlow et al. in The unified protocol for transdiagnostic treatment of emotional disorders: therapist guide, Oxford University Press, New York, 2011) to understand potential for implementation. Qualitative interviews were conducted based on an established implementation framework and speak to implementation of transdiagnostic treatment in veterans, including insight into barriers, facilitators, intervention characteristics, patient characteristics, and system level variables. The UP demonstrated promise for improving efficiency, satisfaction and personalizing mental healthcare.

Emergence of Transdiagnostic Treatments for PTSD and Posttraumatic Distress.

Both theoretical and empirical findings have demonstrated similarities across diagnoses, leading to a growing interest in transdiagnostic interventions. Most of the evidence supporting transdiagnostic treatment has accumulated for depression, anxiety, and eating disorders, with minimal attention given to posttraumatic stress disorder and other reactions to traumatic stressors. Although single-diagnosis protocols are effective for posttraumatic stress disorder (PTSD) and other trauma-related disorders, in principle, transdiagnostic approaches may have beneficial applications within a traumatized population. This paper defines different types of transdiagnostic treatments, reviews transdiagnostic approaches used in related disorders, and discusses their applicability to PTSD. Examples are drawn from existing transdiagnostic treatments in order to provide a framework for the application of such interventions to the field of traumatic stress. Implications for implementation and dissemination are also discussed.

Adapting the National Diabetes Prevention Program: Learning from Lifestyle Coach strategies and adjustments during the COVID-19 pandemic in the United States.

Background: The National Diabetes Prevention Program (National DPP) is an evidence-based lifestyle intervention successfully disseminated across the United States. Some adaptations have been made to address real-world needs, including during the COVID-19 pandemic. This study aims to qualitatively describe adaptations Lifestyle Coaches made in response to the pandemic. Methods: Between May and June 2021, Lifestyle Coaches (n = 300) from organizations across the United States answered open-ended survey questions about adjustments implemented during the pandemic. Survey responses were descriptively coded and codes were grouped into categories. Results: Nearly all coaches transitioned the format of their class from in-person to remote delivery (93.0 %; n = 279). Other commonly-reported strategies included adjusting contact with participants (48.0 %; n = 144), increasing support for participants (36.7 %; n = 110), and tailoring materials (28.3 %; n = 85). Conclusions: Maintaining these adaptations may address barriers to engagement in the National DPP and improve access to the program. Increased support for emotional symptoms and ensuring a patient-centered approach to care are particularly promising strategies.

Safety and Effectiveness From the Cabotegravir and Rilpivirine Implementation Study in European Locations Study: Phase 3b Hybrid Type III Implementation Study Integrating Cabotegravir + Rilpivirine Long-Acting Into European Clinical Settings.

BACKGROUND: Cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months (Q2M) is a complete regimen for the maintenance of HIV-1 virologic suppression. In this study, we report month 12 clinical outcomes in patient study participants (PSPs) in the CAB and RPV Implementation Study in European Locations (CARISEL) study. SETTING: CARISEL is a phase 3b implementation-effectiveness study. METHODS: CARISEL was designed as a 2-arm, unblinded study with centers randomized to either enhanced or standard implementation arms. For PSPs, this study is single arm, unblinded, and interventional; all PSPs switched from daily oral therapy to CAB + RPV LA dosed Q2M. The primary objective was to evaluate the perceived acceptability, appropriateness, and feasibility of CAB + RPV LA implementation for staff participants (presented separately). Clinical secondary endpoints assessed through month 12 included the proportion of PSPs with plasma HIV-1 RNA ≥50 and <50 copies/mL (Snapshot algorithm), incidence of confirmed virologic failure (CVF; 2 consecutive plasma HIV-1 RNA levels ≥200 copies/mL), adherence to injection visit windows, and safety and tolerability. RESULTS: Four hundred thirty PSPs were enrolled and treated; the mean age was 44 years (30% ≥50 years), 25% were women (sex at birth), and 22% were persons of color. At month 12, 87% (n = 373/430) of PSPs maintained HIV-1 RNA <50 copies/mL, with 0.7% (n = 3/430) having HIV-1 RNA ≥50 copies/mL. One PSP had CVF. The safety profile was consistent with previous findings. Overall, the results were similar between implementation arms. CONCLUSION: CAB + RPV LA Q2M was well tolerated and highly effective in maintaining virologic suppression with a low rate of virologic failure.

Patient Participant Perspectives on Implementation of Long-Acting Cabotegravir and Rilpivirine: Results From the Cabotegravir and Rilpivirine Implementation Study in European Locations (CARISEL) Study.

INTRODUCTION: CARISEL is an implementation-effectiveness "hybrid" study examining the perspectives of people living with HIV-1 (patient study participants [PSPs]) on cabotegravir (CAB) plus rilpivirine (RPV) long-acting (LA) dosed every 2 months (Q2M) across 5 European countries. METHODS: PSPs completed questionnaires on acceptability (Acceptability of Intervention Measure), appropriateness (Intervention Appropriateness Measure), and feasibility (Feasibility of Intervention Measure) at their first (Month [M] 1), third (M4), and seventh (M12) injection visits. Semistructured qualitative interviews were also conducted. RESULTS: Overall, 437 PSPs were enrolled, of whom 430 received treatment. Median (interquartile range) age was 44 (37-51) years, 25.3% (n = 109/430) were female (sex at birth), and 21.9% (n = 94/430) were persons of color. Across time points, PSPs found CAB + RPV LA highly acceptable, appropriate, and feasible (mean scores ≥4.47/5). Qualitative data supported these observations. CONCLUSIONS: PSPs found CAB + RPV LA Q2M to be an acceptable, appropriate, and feasible treatment option.

Implementation of long-acting cabotegravir and rilpivirine: primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations.

INTRODUCTION: Cabotegravir plus rilpivirine (CAB + RPV) is the first complete long-acting (LA) regimen recommended for maintaining HIV-1 virological suppression. Cabotegravir And Rilpivirine Implementation Study in European Locations (CARISEL) is an implementation-effectiveness study examining the implementation of CAB+RPV LA administered every 2 months (Q2M) in European HIV centres. We present staff study participant (SSP) perspectives on the administration of CAB+RPV LA over 12 months. METHODS: Eighteen clinics were randomized to one of two implementation support packages: standard arm (Arm-S) or enhanced arm (Arm-E). Arm-S included video injection training and provider/patient toolkits. Additionally, Arm-E included skilled wrap-around team meetings, face-to-face injection training and continuous quality improvement (CQI) calls. SSPs completed surveys on the acceptability, appropriateness and feasibility of CAB+RPV LA as an intervention and its implementation into their clinics, as well as barriers and facilitators to implementation. All surveys were completed at Month (M)1 (baseline), M5 and M12; data collection was completed by February 2022. Qualitative data were obtained from semi-structured interviews at M1, M5 and M12. The primary objective was assessed via formal statistical comparisons between study arms of the Acceptability of Implementation Measure, Implementation Appropriateness Measure and Feasibility of Implementation Measure surveys (1-5 Likert scale ranging from 1 = "completely disagree" to 5 = "completely agree"). Equivalent measures anchored to CAB+RPV LA as a therapy were also assessed. RESULTS: Seventy SSPs completed surveys and interviews at M1, 68 at M5 and 62 at M12. Mean acceptability/appropriateness/feasibility scores were ≥3.8 (out of 5) at M12 for implementation- and intervention-based measures. An analysis of covariance showed no significant differences between study arms for these outcomes. Although barriers were noted, most SSPs were not overly concerned that these would impact implementation; concern about these anticipated barriers also decreased over time. At M12, 90.3% (n = 56/62) of SSPs held a positive opinion about CAB+RPV LA implementation. Qualitative interviews and CQI calls highlighted three top practices that supported implementation: implementation planning; education about CAB+RPV LA clinical efficacy; and education around administering injections and managing pain/discomfort after injections. CONCLUSIONS: CARISEL demonstrated that CAB+RPV LA dosed Q2M was successfully implemented across a range of European locations, with SSPs finding implementation highly acceptable, appropriate and feasible. GOV NUMBER: NCT04399551.

Waitlist-controlled trial of an online intervention to address mental health among older people living with HIV.

Background: Older people living with HIV (PLWH) often experience elevated levels of depression, anxiety, and loneliness.Methods: This waitlist-controlled trial examined the effectiveness of online audio mindfulness lessons in impacting these feelings among older PLWH.Results: Among 214 participants, the mean (SD) age was 60.4 (5.9) years, 89% were male, and 69% were white. After 25 days, the intervention group showed significant improvements versus the waitlist control group in symptoms of depression (20.3% improvement, p < .01) and symptoms of anxiety (22.4% improvement, p = .03), but not in loneliness as measured by a Daily Diary (12.9% improvement, p = .07) or the 3-Item Loneliness Scale (4.8% improvement, p = .27). Secondary analyses among participants with elevated baseline symptoms of depression showed a 26.3% improvement (p < .01), with a moderate effect size (Hedge's g = 0.69). Similarly, those with elevated baseline symptoms of anxiety showed a 25.6% improvement (p < .01), a moderate effect size (g = 0.54), while those with moderate or severely elevated loneliness showed an 18.9% improvement in daily loneliness (p < .01), a moderate effect size (g = 0.55).Conclusion: This waitlist-controlled trial is the first to show that a series of brief, online audio mindfulness lessons improves mental health outcomes among older PLWH. For many patients, this intervention may offer relief that is both accessible and affordable.

The effect of D-cycloserine on subliminal cue exposure in spider fearful individuals.

Research on D-cycloserine (DCS) has demonstrated a significant effect on symptom reduction in human studies that utilized conventional exposure-based approaches. Recent studies have offered promising results for targeting fears through subliminal paradigms. In this double-blind, randomized placebo-controlled study, 45 spider fearful individuals received DCS or placebo pills prior to completing a subliminal cue exposure task to images of spiders. Participants completed self-report questionnaires and a behavioral approach task to a live caged tarantula. After repeated exposure to subliminal spider cues, participants in the DCS group reported a greater reduction in disgust than individuals in the placebo group. No difference was observed in fear ratings. These findings suggest that DCS augments the reduction in disgust in spider fearful subjects after subliminal exposure to spider cues.

Mental health clinician perspectives regarding factors impacting implementation of evidence-based psychotherapies in Veterans Health Administration community-based outpatient clinics.

OBJECTIVE: Uptake of Evidence-Based Psychotherapies (EBPs) by mental health (MH) clinicians, especially in community settings, remains highly variable. This formative pilot study aimed to understand the attitudes and practices of Veterans Health Administration community-based MH clinicians regarding EBPs and to identify multi-level factors that enable and hinder EBP implementation in this unique context. METHODS: Semi-structured interviews were conducted with MH clinicians (N = 40) working in community-based outpatient clinics (CBOCs) in metro/urban (n = 20) and non-metro/rural (n = 20) locations. Interviews were guided by the Consolidated Framework for Implementation Research and were analyzed using rapid content analysis. Results were organized by system-, clinician-, patient-, and innovation-levels. RESULTS: EBPs were consistently perceived as important to delivering quality MH care, with most clinicians having received training in at least one VHA EBP. However, limited EBP training and consultation opportunities, inadequate autonomy to schedule EBP sessions, high and complex caseloads, and feelings of isolation at CBOCs decreased EPB use. Social workers perceived disparities in EBP training access relative to psychologists. Some barriers were more salient in non-metro/rural settings (e.g., patient-level privacy concerns). CONCLUSIONS: Increased EBP training opportunities- particularly for social workers-, greater flexibility over schedules and caseloads, and more mechanisms for consultation and professional development may increase EBP uptake in community-based clinics.

A scoping review of frameworks in empirical studies and a review of dissemination frameworks.

BACKGROUND: The field of dissemination and implementation (D&I) research has grown immensely in recent years. However, the field of dissemination research has not coalesced to the same degree as the field of implementation research. To advance the field of dissemination research, this review aimed to (1) identify the extent to which dissemination frameworks are used in dissemination empirical studies, (2) examine how scholars define dissemination, and (3) identify key constructs from dissemination frameworks. METHODS: To achieve aims 1 and 2, we conducted a scoping review of dissemination studies published in D&I science journals. The search strategy included manuscripts published from 1985 to 2020. Articles were included if they were empirical quantitative or mixed methods studies about the dissemination of information to a professional audience. Studies were excluded if they were systematic reviews, commentaries or conceptual papers, scale-up or scale-out studies, qualitative or case studies, or descriptions of programs. To achieve aim 1, we compiled the frameworks identified in the empirical studies. To achieve aim 2, we compiled the definitions from dissemination from frameworks identified in aim 1 and from dissemination frameworks identified in a 2021 review (Tabak RG, Am J Prev Med 43:337-350, 2012). To achieve aim 3, we compile the constructs and their definitions from the frameworks. FINDINGS: Out of 6017 studies, 89 studies were included for full-text extraction. Of these, 45 (51%) used a framework to guide the study. Across the 45 studies, 34 distinct frameworks were identified, out of which 13 (38%) defined dissemination. There is a lack of consensus on the definition of dissemination. Altogether, we identified 48 constructs, divided into 4 categories: process, determinants, strategies, and outcomes. Constructs in the frameworks are not well defined. IMPLICATION FOR D&I RESEARCH: This study provides a critical step in the dissemination research literature by offering suggestions on how to define dissemination research and by cataloging and defining dissemination constructs. Strengthening these definitions and distinctions between D&I research could enhance scientific reproducibility and advance the field of dissemination research.

Barriers to participation and lifestyle change among lower versus higher income participants in the National Diabetes Prevention Program: lifestyle coach perspectives.

Individuals from socioeconomically disadvantaged groups have lesser participation and success in the National Diabetes Prevention Program (NDPP). Barriers to NDPP participation and lifestyle change were examined from the perspective of Lifestyle Coaches serving lower versus higher income participants. Lifestyle Coaches (n = 211) who serve lower income (n = 82) or higher income (n = 129) participants reported on observed barriers to NDPP participation and lifestyle change and ranked the three most significant barriers to (a) NDPP participation and (b) lifestyle change. Group differences in number/type of barriers were examined using t-tests and chi-square analyses, and ranking differences were examined using multilevel cumulative logit models. Lifestyle Coaches of lower income (versus higher income) participants reported two additional barriers on average. Ranked barriers to participation were similar between groups, and notably included physical/emotional barriers. However, for lifestyle change, those serving lower income groups were more likely to rank lack of access to healthy grocery stores, but less likely to rank low motivation and lack of family support. Lifestyle Coaches of lower income participants were less likely to rank long wait period prior to enrollment as the most significant barrier to participation, and to rank lack of time off from work as the most significant barrier to lifestyle change. Despite more barriers observed among lower versus higher income participants, overlap in the most significant barriers highlights the potential utility of widely addressing common barriers among NDPP participants. In particular, physical and emotional barriers have been overlooked, yet deserve greater attention in future research and practice.

The National Diabetes Prevention Program (NDPP) has less successfully reached and changed the lifestyles of lower income (versus higher income) adults in the USA who are at high risk for type 2 diabetes. In a nationwide online survey, we asked Lifestyle Coaches who deliver the NDPP to identify up to 37 potential barriers to participation and success that they had observed among their participants. We then compared the number, type, and rankings of the most significant barriers to participation and success in the NDPP from the perspective of Lifestyle Coaches estimating the majority of their participants had lower versus higher incomes. Lifestyle Coaches delivering the NDPP to lower income participants reported an average of two additional barriers to participation and success than those delivering the program to higher income participants. The barriers ranked among the most significant to NDPP participation and lifestyle change were generally similar among Lifestyle Coaches working with lower versus higher income participants. Top-ranked barriers included physical/emotional symptoms (e.g., anxiety, depression) as well as barriers previously reported in studies focused on NDPP participants. It is critical that barriers be carefully evaluated and addressed to improve the nationwide impact of the NDPP.

Promises and Pitfalls of Dyads in the National Diabetes Prevention Program: Lifestyle Coach Perspectives.

PURPOSE: To describe Lifestyle Coach perceptions of dyads (i.e., family members and/or friends) in the National Diabetes Prevention Program (NDPP). DESIGN: Qualitative evaluation of cross-sectional survey responses. SETTING: Online. PARTICIPANTS: Lifestyle Coaches (n=253) with experience teaching at least one in-person year-long NDPP cohort at a CDC-recognized organization. MEASURES: Survey included items on background and experience with dyadic approach, as well as open-ended items on the benefits and challenges observed when working with dyads in the NDPP. ANALYSIS: Lifestyle Coach background and experience were analyzed descriptively in SPSS. Open-ended responses were content coded in ATLAS.ti using qualitative description, and then grouped into categories. RESULTS: Most Lifestyle Coaches (n=210; 83.0%) reported experience delivering the NDPP to dyads. Benefits of a dyadic approach included having a partner in lifestyle change, superior outcomes and increased engagement, and positive "ripple effects." Challenges included difficult relationship dynamics, differences between dyad members, negative "ripple effects," and logistics. CONCLUSION: Lifestyle Coaches described a number of benefits, as well as some challenges, with a dyadic approach to the NDPP. Given the concordance between close others in lifestyle and other risk factors for type 2 diabetes, utilizing a dyadic approach in the NDPP has the potential to increase engagement, improve outcomes, and extend the reach of the program.

The FRAME-IS: a framework for documenting modifications to implementation strategies in healthcare.

BACKGROUND: Implementation strategies are necessary to ensure that evidence-based practices are successfully incorporated into routine clinical practice. Such strategies, however, are frequently modified to fit local populations, settings, and contexts. While such modifications can be crucial to implementation success, the literature on documenting and evaluating them is virtually nonexistent. In this paper, we therefore describe the development of a new framework for documenting modifications to implementation strategies. DISCUSSION: We employed a multifaceted approach to developing the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS), incorporating multiple stakeholder perspectives. Development steps included presentations of initial versions of the FRAME-IS to solicit structured feedback from individual implementation scientists ("think-aloud" exercises) and larger, international groups of researchers. The FRAME-IS includes core and supplementary modules to document modifications to implementation strategies: what is modified, the nature of the modification (including the relationship to core elements or functions), the primary goal and rationale for the modification, timing of the modification, participants in the modification decision-making process, and how widespread the modification is. We provide an example of application of the FRAME-IS to an implementation project and provide guidance on how it may be used in future work. CONCLUSION: Increasing attention is being given to modifications to evidence-based practices, but little work has investigated modifications to the implementation strategies used to implement such practices. To fill this gap, the FRAME-IS is meant to be a flexible, practical tool for documenting modifications to implementation strategies. Its use may help illuminate the pivotal processes and mechanisms by which implementation strategies exert their effects.

A Novel Approach to the Assessment of Fidelity to a Cognitive Behavioral Therapy for PTSD Using Clinical Worksheets: A Proof of Concept With Cognitive Processing Therapy.

Fidelity monitoring is a critical indicator of psychotherapy quality and is central to successful implementation. A major barrier to fidelity in routine care is the lack of feasible, scalable, and valid measurement strategies. A reliable, low-burden fidelity assessment would promote sustained implementation of cognitive behavioral therapies (CBTs). The current study examined fidelity measurement for cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) using clinical worksheets. External raters evaluated patient worksheets done as a part of treatment, both guided by the therapist and completed independently as homework. Results demonstrated that fidelity ratings from CPT session worksheets were feasible and efficient. Notably, they were strongly correlated with observer ratings of the fidelity of CPT strategies that were present on the worksheets. Agreement among ratings conducted by individuals with a range of experience with CPT was acceptable to high. There was not a main effect of therapist-guided, in-session worksheet ratings on PTSD symptom change. However, patient competence in completing worksheets independently was associated with greater PTSD symptom decline and in-session, therapist-guided worksheet completion was associated with larger symptom decreases among patients with high levels of competence. With further research and refinement, rating of worksheets may be an efficient way to examine therapist and patient skill in key CPT elements, and their interactions, compared to the gold standard of observer ratings of therapy video-recordings. Additional research is needed to determine if worksheets are an accurate and scalable alternative to gold standard observer ratings in settings in which time and resources are limited.