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✪ Implementation of Obesity Science into Clinical Practice: A Scientific Statement from the American Heart Association

Authors:

Deepika Laddu, Ian J. Neeland, Mercedes Carnethon, Fatima C. Stanford, Morgana Mongraw-Chaffin, Bethany Barone Gibbs, Chiadi E. Ndumele, Chris T. Longenecker, Misook L. Chung, and Goutham Rao

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 22, 2022

Read the full text in the open access journal Circulation

Abstract:

Background

Effective implementation strategies are needed to enhance the success of evidence-based prevention programs. The current study evaluates the effects of two implementation strategies on teachers’ implementation of an evidenced-based HIV intervention

Methods

Using our 7-item pre-implementation school screening tool, we identified teachers who were at-risk for not implementing the Focus on Youth HIV-risk reduction intervention curriculum which targets grade six through grade 8 students. After completing a two-day curriculum workshop, 81 low- and moderate-performing teachers were randomly assigned to one of four experimental conditions and were asked to teach the two-month intervention curriculum. This optimization trial examines the impact of two implementation strategies: biweekly monitoring/feedbacks (BMF) and site-based assistance/mentorship (SAM). The primary outcome is implementation fidelity defined as number of core activities taught. Linear mixed-effects model was used to examine the association of the implementation strategies with implementation fidelity.

Results

BMF and SAM were significantly associated with teachers’ implementation fidelity. Teachers who received both BFM and SAM taught the greatest numbers of core activities (15 core activities on average), followed by teachers who received either BMF (6.9 activities) or SAM (7.9 activities). Teachers who did not receive BMF or SAM taught the lowest numbers (4.1 activities). Teachers’ sustained implementation of FOYC in the prior school year was related to increased implementation fidelity during the optimization trial. Teachers’ confidence in implementing five core activities, attitudes toward sex education in schools, and perceived principal support were significantly related to increased self-efficacy, which in turn was related to teachers’ fidelity of implementation before the optimization trial.

Conclusions

BMF and SAM are effective in promoting teachers’ implementation of youth evidence-based interventions. Researchers and future program implementers should consider teacher training, teachers’ attitudes toward sex education, perceived principal support, and self-efficacy when attempting to maintain the effects of teacher-delivered interventions in schools.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ A formative mixed methods evaluation of a new Ross program: Why context matters

Authors:

Kyle S. Bilodeau, Frank F. Yang, Michael Shang, Audrey Mossman, David C. Mauchley, Scott DeRoo, & Christopher R. Burke

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2024

Read the full text in the open access journal The Cardiothoracic Surgeon

Abstract:

Background

The Ross procedure is a technically complex operation to address the pathology of the aortic valve. Prior attempts at widespread implementation have been plagued with variations in effectiveness. We report our initial programmatic outcomes using dissemination and implementation (D&I) science frameworks, with an aim to define both programmatic efficacy and effectiveness. The study design was a single center, explanatory sequential mixed methods evaluation of a Ross surgery program from June 2020 to April 2023. Quantitative measures for baseline patient characteristics and postoperative outcomes were summarized. Qualitative measures were obtained using semi-structured interviews and characterized using implementation science frameworks.

Results

A total of 71 patients underwent the Ross procedure at a single academic center. Mean age was 40 years (± 13). There were no perioperative deaths or valve-related reinterventions (0%). During the follow-up period, 2 (2.8%) patients required re-operation and 2 (2.8%) required balloon dilation of the pulmonary homograft. Qualitative measures noted communication and prospective self-audit facilitated measures of effectiveness, as dichotomy within expected vs. observed outcomes led to program modifications. Collaboration across hospital systems promoted adoption and implementation, which led to the incorporation of the Ross procedure into accepted organizational practice.

Conclusions

In this formative evaluation, limited-efficacy outcomes demonstrated similar programmatic success to data from other established centers. With the prerequisite center volume and case selection, the Ross procedure is a safe and efficacious treatment for aortic valvular disease. Implementation science can be used both in real-time and retrospectively to guide organizational efforts to improve outcomes and to improve the translation of results across centers.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ “A problem shared is a problem solved:” integrating human-centered design and implementation science to optimize lay counselor supervision in Western Kenya

Authors:

Noah S. Triplett, Anne Mbwayo, Sharon Kiche, Enoch Sackey, Rashed AlRasheed, Daisy Anyango Okoth, Omariba Anne Nyaboke, Cyrilla Amanya & Shannon Dorsey

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2024

Read the full text in the open access journal Social Science and Medicine - Mental Health

Abstract:

Implementation science and human-centered design (HCD) offer useful frameworks and methods for considering and designing for individuals' needs and preferences when implementing new interventions or technologies in global health. When used in tandem, the two approaches may blend creative and partnered research methods with a focus on the factors necessary to design, implement, and sustain interventions. However, research is needed that describes the process of blending these two approaches and explores the experiences of community partners. This study builds from a stepped-wedge cluster-randomized trial in Western Kenya, wherein teachers and community health volunteers have been trained to provide trauma-focused cognitive behavioral therapy (TF-CBT). Mobile phones emerged as a tool to supervise lay counselors from afar; however, their use was characterized by unique challenges. Informed by human-centered design and implementation science, we first engaged lay counselors (n = 24) and supervisors (n = 3) in individual semi-structured interviews then hosted an in-person participatory workshop to “co-design” solutions to optimize the use of mobile phone supervision. Lay counselors participated in focus group discussions regarding their experiences in the workshop. Focus group transcripts were analyzed using thematic analysis. We describe our approach as well as focus group discussion results. Counselors felt the workshop was a valuable experience to learn new strategies from their colleagues, and they enjoyed the “collaborative spirit” that emerged as they worked together. Counselors felt that varying small and large group discussions fostered participation by creating opportunities for more people to engage and share their thoughts. Counselors suggested the approach be improved by providing more tangible materials (e.g., hand-outs) and more closely following a schedule of activities. It is important to also center stakeholders’ experiences as partners in the research process. Though counselors largely expressed positive sentiments, they also shared valuable suggestions for how to improve participatory research practices in the future.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Using policy codesign to achieve multi-sector alignment in adolescent behavioral health: a study protocol

Authors:

Sarah Cusworth Walker, Kym R. Ahrens, Mandy D. Owens, McKenna Parnes, Joe Langley, Christine Ackerley, Jonathan Purtle, Lisa Saldana, Gregory A. Aarons, Aaron Hogue & Lawrence A. Palinkas

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2024

Read the full text in the open access journal Implementation Science Communications

Abstract:

Background

Policymaking is quickly gaining focus in the field of implementation science as a potential opportunity for aligning cross-sector systems and introducing incentives to promote population health, including substance use disorders (SUD) and their prevention in adolescents. Policymakers are seen as holding the necessary levers for realigning service infrastructure to more rapidly and effectively address adolescent behavioral health across the continuum of need (prevention through crisis care, mental health, and SUD) and in multiple locations (schools, primary care, community settings). The difficulty of aligning policy intent, policy design, and successful policy implementation is a well-known challenge in the broader public policy and public administration literature that also affects local behavioral health policymaking. This study will examine a blended approach of coproduction and codesign (i.e., Policy Codesign), iteratively developed over multiple years to address problems in policy formation that often lead to poor implementation outcomes. The current study evaluates this scalable approach using reproducible measures to grow the knowledge base in this field of study.

Methods

This is a single-arm, longitudinal, staggered implementation study to examine the acceptability and short-term impacts of Policy Codesign in resolving critical challenges in behavioral health policy formation. The aims are to (1) examine the acceptability, feasibility, and reach of Policy Codesign within two geographically distinct counties in Washington state, USA; (2) examine the impact of Policy Codesign on multisector policy development within these counties using social network analysis; and (3) assess the perceived replicability of Policy Codesign among leaders and other staff of policy-oriented state behavioral health intermediary organizations across the USA.

Discussion

This study will assess the feasibility of a specific approach to collaborative policy development, Policy Codesign, in two diverse regions. Results will inform a subsequent multi-state study measuring the impact and effectiveness of this approach for achieving multi-sector and evidence informed policy development in adolescent SUD prevention and treatment.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ How pharmacists would design and implement a community pharmacy-based colorectal cancer screening program

Authors:

Austin R Waters, Katherine Meehan, Dana L Atkins, Annika H Ittes, Renée M Ferrari, Catherine L Rohweder, Mary Wangen, Rachel M Ceballos, Rachel B Issaka, Daniel S Reuland, Stephanie B Wheeler, Alison T Brenner, and Parth D Shah

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Preventive Oncology & Epidemiology

Abstract:

Background

Distributing CRC screening through pharmacies, a highly accessible health service, may create opportunities for more equitable access to CRC screening. However, providing CRC screening in a new context introduces a substantial implementation challenge.

Methods

We conducted 23 semi-structured interviews with community pharmacists practicing in Washington state and North Carolina about distributing fecal immunochemical tests (FIT) to patients in the pharmacy. The Consolidated Framework for Implementation Research (CFIR) was used to guide analysis.

Results

Pharmacists believed that delivering FITs was highly compatible with their environment, workflow, and scope of practice. While knowledge about FIT eligibility criteria varied, pharmacists felt comfortable screening patients. They identified standardized eligibility criteria, patient-facing educational materials, and continuing education as essential design features. Pharmacists proposed adapting existing pharmacy electronic health record systems for patient reminders/prompts to facilitate FIT completion. While pharmacists felt confident that they could discuss test results with patients, they also expressed a need for stronger communication and care coordination with primary care providers.

Discussion

When designing a pharmacy-based CRC screening program, pharmacists desired programmatic procedures to fit their current knowledge and context. Findings indicate that if proper attention is given to multi-level factors, FIT delivery can be extended to pharmacies.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Implementation Research at NHLBI: Methodological and Design Challenges and Lessons Learned from the DECIPHeR Initiative

Authors:

David M Murray, Patrick Heagerty, James Troendle, Feng-Chang Lin, Jonathan Moyer, June Stevens, Leslie Lytle, Xinzhi Zhang, Maliha Ilias, Mary Y Masterson, Nicole Redmond, Veronica Tonwe, Dave Clark & George A Mensah

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Ethnicity & Disease

Abstract:

NHLBI funded seven projects as part of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Initiative. They were expected to collaborate with community partners to (1) employ validated theoretical or conceptual implementation research frameworks, (2) include implementation research study designs, (3) include implementation measures as primary outcomes, and (4) inform our understanding of mediators and mechanisms of action of the implementation strategy. Several projects focused on late-stage implementation strategies that optimally and sustainably delivered two or more evidence-based multilevel interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities and to improve population health in high-burden communities. Projects that were successful in the three-year planning phase transitioned to a 4-year execution phase. NHLBI formed a Technical Assistance Workgroup during the planning phase to help awardees refine study aims, strengthen research designs, detail analytic plans, and to use valid sample size methods. This paper highlights methodological and study design challenges encountered during this process. Important lessons learned included (1) the need for greater emphasis on implementation outcomes, (2) the need to clearly distinguish between intervention and implementation strategies in the protocol, (3) the need to address clustering due to randomization of groups or clusters, (4) the need to address the cross-classification that results when intervention agents work across multiple units of randomization in the same arm, (5) the need to accommodate time-varying intervention effects in stepped-wedge designs, and (6) the need for data-based estimates of the parameters required for sample size estimation.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Virtual versus usual in-office care for multiple sclerosis: The VIRTUAL-MS multi-site randomized clinical trial study protocol

Authors:

Marisa McGinley, Josh J Carlson, Jennifer Reihm, Matthew Plow, Megan Roser, Nikki Sisodia, Jeffrey A Cohen, Anita D Misra-Hebert, Ann A Lazar & Riley Bove

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Contemporary Clinical Trials

Abstract:

Background

Multiple sclerosis (MS) affects nearly 1 million people and is estimated to cost $85.4 billion in the United States annually. People with MS have significant barriers to receiving care and telemedicine could substantially improve access to specialized, comprehensive care. In cross-sectional analyses, telemedicine has been shown to be feasible, have high patient and clinician satisfaction, reduce patient costs and burden, and enable a reasonable assessment of disability. However, no studies exist evaluating the longitudinal impact of telemedicine care for MS. Here we describe the study protocol for VIRtual versus UsuAL In-office care for Multiple Sclerosis (VIRTUAL-MS). The main objective of the study is to evaluate the impact of telemedicine for MS care on: patient clinical outcomes, economic costs, patient, and clinician experience.

Methods

This two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes.

Conclusion

The results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Systems analysis and improvement approach to optimize tuberculosis (SAIA-TB) screening, treatment, and prevention in South Africa: a stepped-wedge cluster randomized trial

Authors:

Brittney J. van de Water, Meredith B. Brooks, Refiloe Matji, Betty Ncanywa, Freck Dikgale, Nadia N. Abuelezam, Bulelwa Mzileni, Miyakazi Nokwe, Singilizwe Moko, Lindiwe Mvusi, Marian Loveday, & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Implementation Science Communication

Abstract:

Background

The use of systems engineering tools, including the development and use of care cascades using routinely collected data, process mapping, and continuous quality improvement, is used for frontline healthcare workers to devise systems level change. South Africa experiences high rates of tuberculosis (TB) infection and disease as well as HIV co-infection. The Department of Health has made significant gains in HIV services over the last two decades, reaching their set “90–90-90” targets for HIV. However, TB services, although robust, have lagged in comparison for both disease and infection. The Systems Analysis and Improvement Approach (SAIA) is a five-step implementation science method, drawn from systems engineering, to identify, define, and implement workflow modifications using cascade analysis, process mapping, and repeated quality improvement cycles within healthcare facilities.

Methods

This stepped-wedge cluster randomized trial will evaluate the effectiveness of SAIA on TB (SAIA-TB) cascade optimization for patients with TB and high-risk contacts across 16 clinics in four local municipalities in the Sarah Baartman district, Eastern Cape, South Africa. We hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. Focus group discussions and key informant interviews with clinic staff will also be conducted to determine drivers of implementation variability across clinics.

Discussion

This study has the potential to improve TB screening, treatment initiation, and completion for both active disease and preventive measures among individuals with and without HIV in a high burden setting. SAIA-TB provides frontline health care workers with a systems-level view of their care delivery system with the aim of sustainable systems-level improvements.

Trial registration

Clinicaltrials.gov, NCT06314386. Registered 18 March 2024, https://clinicaltrials.gov/study/NCT06314386. NCT06314386.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Acceptability of venue-based HIV testing and prevention interventions for men who have sex with transgender women and transgender women in Lima, Perú: a formative, qualitative study

Authors:

Alexander Lankowski, Deanna Tollefson, Hugo Sánchez, Robinson Cabello, José Hidalgo, Mary N Mathison, Yamilé Molina & Ann Duerr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal HIV Research & Clinical Practice

Abstract:

Background

Despite being at elevated risk for HIV, men who have sex with transgender women (MSTW) are an overlooked population in the global HIV response. Venue-based HIV interventions have previously had success reaching other HIV priority populations, including transgender women (TW). Similar approaches could be applied for MSTW.

Objective

To evaluate the prospective acceptability of venue-based HIV testing and prevention interventions for MSTW and TW in Lima, Peru.

Methods

In this exploratory qualitative study, we conducted in-depth interviews (IDI) and focus group discussions (FGD) with three types of participants: MSTW (7 IDIs, 1 FGD), TW (1 FGD), and owners of social venues frequented by MSTW/TW in Lima (2 IDIs). We elicited participants’ attitudes and perceptions related to the following four hypothetical interventions delivered at social venues in Lima: rapid HIV testing; HIV self-test distribution; condom/lubricant distribution; and enrolment in a mobile app supporting HIV prevention. We performed a mixed deductive-inductive thematic analysis using the framework method, then applied the Theoretical Framework of Acceptability to classify the overall acceptability of each intervention.

Results

Condom/lubricant distribution and app-based HIV prevention information were highly acceptable among all participant types. The two HIV testing interventions had relatively lower acceptability; however, participants suggested this could be overcome if such interventions focused on ensuring discretion, providing access to healthcare professionals, and offering appropriate incentives.

Conclusions

Overall, MSTW and TW shared similar favourable attitudes towards venue-based HIV interventions. Venue-based outreach warrants further exploration as a strategy for engaging MSTW and TW in HIV prevention activities.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**