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✪ Methodology for adapting a co-created early childhood development intervention and implementation strategies for use by frontline workers in India and Guatemala: a systematic application of the FRAME-IS framework

Authors:

Amruta Bandal, Sara Hernández, Revan Mustafa, Karyn Choy, Namrata Edwards, Magdalena Guarchaj, Marinés Mejía Alvarez, Anushree Sane, Scott Tschida , Chetna Maliye, Ann Miller, Abhishek Raut, Roopa Srinivasan, Morgan Turner, Bradley H. Wagenaar , Ilgi Ertem, Maria del Pilar Grazioso, Subodh S. Gupta, Vibha Krishnamurthy, and Peter Rohloff.

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2026

Read the full text in the open access journal Global Health Action

Abstract:

There is little evidence on optimizing the effectiveness and implementation of evidence-based early childhood development (ECD) interventions when task-shifted to frontline workers. In this Methods Forum paper, we describe our adaptation of the International Guide for Monitoring Child Development (GMCD) for task-shifting to frontline workers in Guatemala and India. In 2021–2022, implementers, trainers, frontline workers, caregivers, and international GMCD experts collaborated to adapt the GMCD for a task shifted implementation by frontline workers. We used an eight-step co-creating process: assembling a multidisciplinary team, training on the existing package, working groups to begin modifications, revision of draft modifications, tailoring of visual materials and language, train-the-trainers activities, pilot frontline worker trainings, final review and feedback. Preliminary effectiveness of adaptations was evaluated through narrative notes and group-based qualitative feedback following pilot trainings with 16 frontline workers in India and 6 in Guatemala. Final adaptations included: refining training techniques to match skill levels and learning styles of frontline workers; tailoring all visual materials to local languages and contexts; design of job aids for providing developmental support messages; modification of referral and triage processes for children in need of enhanced support and specialty referral; and creation of post-training support procedures. Feedback from pilot trainings included: (1) group consensus that training improved ECD skills and knowledge across multiple domains; and (2) feedback on ongoing needed adjustments to pacing, use of video-based vs. role-playing materials, and time allocated to small group work. We use the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) framework to document our adaptations. The co-creating approach we use, as well as systematic documentation of adaptation decisions will be of use to other community-based early childhood interventions and implementation strategies.

**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**

Imagining and implementing healthy city interventions: Combined results from parallel concept mapping exercises in Montreal with community members and stakeholders

Authors:

Zoé Poirier Stephens, Caislin Leah Firth, Michael Cantinotti, Daniel Fuller, Meghan Winters & Yan Kestens

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: May 2024

Read the full text in the subscription access journal Canadian Journal of Public Health

✪ Getting cozy with causality: Advances to the causal pathway diagramming method to enhance implementation precision

Authors:

Predrag Klasnja, Rosemary D. Meza, Michael D. Pullmann, Kayne D. Mettert, Rene Hawkes, Lorella Palazzo, Bryan J. Weiner, and Cara C. Lewis

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Background

Implementation strategies are theorized to work well when carefully matched to implementation determinants and when factors—preconditions, moderators, etc.—that influence strategy effectiveness are prospectively identified and addressed. Existing methods for strategy selection are either imprecise or require significant technical expertise and resources, undermining their utility. This article outlines refinements to causal pathway diagrams (CPDs), a method for articulating the causal process through which implementation strategies work and offers illustrations of their use.

Method

CPDs are a visualization tool to represent an implementation strategy, its mechanism(s) (i.e., the processes through which a strategy is thought to operate), determinants it is intended to address, factors that may impede or facilitate its effectiveness, and the series of outcomes that should be expected if the strategy is operating as intended. We offer principles for constructing CPDs and describe their key functions.

Results

Applications of the CPD method by study teams from two National Institute of Health-funded Implementation Science Centers and a research grant are presented. These include the use of CPDs to (a) match implementation strategies to determinants, (b) understand the conditions under which an implementation strategy works, and (c) develop causal theories of implementation strategies.

Conclusions

CPDs offer a novel method for implementers to select, understand, and improve the effectiveness of implementation strategies. They make explicit theoretical assumptions about strategy operation while supporting practical planning. Early applications have led to method refinements and guidance for the field.

**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**