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✪ Digital communication between mothers and community health workers to support neonatal health (CHV-NEO): study protocol for a randomized controlled trial

Authors:

Keshet Ronen, Lincoln C. Pothan, Violet Apondi, Felix A. Otieno, Daniel Mwakanema, Felix O. Otieno, Lusi Osborn, Julia C. Dettinger, Priyanka Shrestha, Helena Manguerra, Ferdinand Mukumbang, Millicent Masinde, Evelyn Waweru, Mercy Amulele, Christine Were, Beatrice Wasunna, Grace John-Stewart, Bryan Weiner, Arianna Rubin Means, Barbra A. Richardson, Anna B. Hedstrom, Jennifer A. Unger & John Kinuthia

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2024

Read the full text in the open access journal Trials

Abstract:

Background

Provision of essential newborn care at home, rapid identification of illness, and care-seeking by caregivers can prevent neonatal mortality. Mobile technology can connect caregivers with information and healthcare worker advice more rapidly and frequently than healthcare visits. Community health workers (CHWs) are well-suited to deliver such interventions. We developed an interactive short message service (SMS) intervention for neonatal health in Kenya, named CHV-NEO. CHV-NEO sends automated, theory-based, actionable, messages throughout the peripartum period that guide mothers to evaluate maternal and neonatal danger signs and facilitate real-time dialogue with a CHW via SMS. We integrated this intervention into Kenya’s national electronic community health information system (eCHIS), which is currently used at scale to support CHW workflow.

Methods

The effect of CHV-NEO on clinical and implementation outcomes will be evaluated through a non-blinded cluster randomized controlled trial. Twenty sites across Kisumu County in Western Kenya were randomized 1:1 to provide either the national eCHIS with integrated CHV-NEO messaging (intervention) or standard of care using eCHIS without CHV-NEO (control). We will compare neonatal mortality between arms based on abstracted eCHIS data from 7200 pregnant women. Secondary outcomes include self-reported provision of essential newborn care (appropriate cord care, thermal care, and timely initiation of breastfeeding), knowledge of neonatal danger signs, and care-seeking for neonatal illness, compared between arms based on questionnaires with a subgroup of 2000 women attending study visits at enrollment in pregnancy and 6 weeks postpartum. We will also determine CHV-NEO’s effect on CHW workflows and evaluate determinants of intervention acceptability, adoption, and fidelity of use through questionnaires, individual interviews, and messaging data.

Discussion

We hypothesize that the CHV-NEO direct-to-client communication strategy can be successfully integrated within existing CHW workflows and infrastructure, improve the provision of at-home essential newborn care, increase timely referral of neonatal illness to facilities, and reduce neonatal mortality. The intervention’s integration into the national eCHIS tool will facilitate rapid scale-up if it is clinically effective and successfully implemented.

Trial registration

ClinicalTrials.gov, NCT05187897. The CHV-NEO study was registered on January 12, 2022.

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

✪ Integrating early child development into an existing health and nutrition program: evidence from a cluster-randomized controlled trial

Authors:

Caitlin Hemlock, Emanuela Galasso, Ann M. Weber, Tsirery Christian Randriamiarisoa, Mathilde Col, Maria Dieci, Lisy Ratsifandrihamanana & Lia C.H. Fernald

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal BMC Public Health

Abstract:

Introduction

In low-resource settings, introducing child health programs into community services may compete for caregiver time. We analyzed the impact of a new early childhood development (ECD) program in rural Madagascar on family attendance at other health services and of adding at-home play materials on program attendance.

Methods

We randomized 75 communities where community health workers (CHWs) implement an existing child health and nutrition program (Projet d’Amélioration des Résultats Nutritionnels or PARN), the status quo. We offered two 6-month cycles of 12 ECD sessions to eligible caregiver-child dyads (6–30 months) in 25 sites [T]; we added take-home play materials in Cycle 2 to 25 sites [T+]. We used differences-in-differences with administrative data to analyze the effect of offering ECD sessions on monthly PARN attendance (T+/T vs. C) among age-eligible children and the impact of toy boxes/libraries on monthly ECD session attendance (T + vs. T). We used random intercept models to analyze characteristics associated with program registration.

Results

We analyzed data for 9,408 dyads; 30% and 32% registered for the program in Cycle 1 and 2 (respectively). On average, CHWs delivered 11.4 sessions (SD: 1.5). Children from wealthier households who already attended PARN sessions were more likely to register, and we found no effect of T or T + on PARN attendance. Adding play materials did not affect monthly ECD session attendance. Children from more populated sites were less likely to participate in both ECD and PARN sessions.

Conclusions

Integrating new services for ECD into the health system was feasible and did not reduce dyad participation in existing services. Investment in health services in more populated areas is needed to provide coverage to all eligible children. Novel strategies should be explored to engage the most vulnerable children in new and existing health services.

Trial registration

AEA Social Science Registry (AEARCTR-0004704) on November 15, 2019 (prospective registration) and ClinicalTrials.gov (NCT05129696) on November 22, 2021 (retrospective registration).

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

✪ Community partner coauthorship for increased implementation science impact: Strengthening capacity and engagement

Authors:

Rebekka M. Lee, Cristina Huebner Torres, James G. Daly, Annette Thomas, Peggy A. Hannon, Sonja Likumahuwa-Ackman and Karen M. Emmons

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text open access in the journal Hepatology Communications

Abstract:

Engaging diverse partners in each phase of the research process is the gold standard of community-engaged research and adds value to the impact of implementation science. However, partner engagement in dissemination, particularly meaningful involvement in developing peer-reviewed manuscripts, is lacking. The Implementation Science Centers in Cancer Control are using the Translational Science Benefits Model to demonstrate the impact of our work beyond traditional metrics, including building capacity and promoting community engagement. This paper presents a case example of one center that has developed a policy for including community partners as coauthors. Standard practices are used to foster clear communications and bidirectional collaboration. Of published papers focused on center infrastructure and implementation research pilots, 92% have community partner coauthors. This includes 21 individuals in roles ranging from physician assistant to medical director to quality manager. Through this intentional experience of co-creation, community partners have strengthened implementation science expertise. Community coauthors have also ensured that data interpretation and dissemination reflect real-world practice environments and offer sustainable strategies for rapid translation to practice improvements. Funders, academic journals, and researchers all have important roles to play in supporting community coauthors as critical thought partners who can help to narrow the gap between research and practice.

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

✪ Reimagining policy implementation science in a global context: a theoretical discussion

Authors:

Kellie List, Peter Agamile, Didier Yélognissè Alia, Peter Cherutich, Kristen Danforth, John Kinuthia, Arianna Rubin Means, Irene Mukui, Nancy Ngumbau, Yanfang Su, Anjuli Dawn Wagner, Bryan J Weiner, and Sarah Masyuko

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal Frontiers in Health Services

Abstract:

Introduction

Policy implementation science (IS) is defined here as generating knowledge and deploying implementation strategies to effectively adopt and integrate evidence-based interventions (EBIs) into policy designs and improve policy implementation and effectiveness (1–3). Most existing policy IS scholarly works originate from the Global North (United States, Canada, and Western Europe) and describe or evaluate strategies to increase the uptake of EBIs (4). The existing Global North-generated frameworks focus less on the critical resources needed to formulate and implement a policy in diverse settings. Current approaches to policy IS lack sufficient contextual nuance to be applicable to...[read more].

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

✪ Usability of a Web-Based App for Increasing Adolescent Vaccination in Primary Care Settings: Think-Aloud and Survey Assessment

Authors:

Stephanie A S Staras, Justin Tauscher, Michelle Vinson, Lindsay A Thompson, Mary A Gerend & Elizabeth A Shenkman

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal JMIR Formative Research

Abstract:

Background

In the United States, only 58% of teens receive the recommended 2 doses of the human papillomavirus vaccine by 15 years of age. Overcoming vaccine hesitancy often requires effective communication between clinicians and parents to address specific concerns. To support this, we developed ProtectMe4, a multilevel, theory-informed web-based intervention designed to address parents’ vaccine-related questions and assist clinicians in discussing vaccine concerns for 4 adolescent vaccines.

Objective

This study aims to evaluate the usability of ProtectMe4 in routine care settings across 3 pediatric primary care clinics. Specifically, the study aims to (1) observe the proposed workflow in practice, (2) identify usability issues experienced by parents and clinicians, and (3) assess the perceptions of both parents and clinicians regarding the app’s usability.

Methods

On designated days in 2020 and 2021, the study team recruited parents of 11- to 12-year-old patients attending appointments with participating clinicians. We conducted think-aloud assessments during routine care visits and administered a usability survey after participants used the app. For parents, we simultaneously video-recorded the app screens and audio-recorded their commentary. For clinicians, observational notes were taken regarding their actions and comments. Timings recorded within the app provided data on the length of use. We reviewed the recordings and notes to compile a list of identified issues and calculated the frequencies of survey responses.

Results

Out of 12 parents invited to use the app, 9 (75%) participated. Two parents who were invited outside of the planned workflow, after seeing the clinician, refused to participate. For the parents whose child’s vaccination record was identified by the app, the median time spent using the app was 9 (range 6-28) minutes. Think-aloud assessment results for parents were categorized into 2 themes: (1) troubleshooting vaccine record identification and (2) clarifying the app content and purpose. Among the 8 parents who completed the survey, at least 75% (6/8) agreed with each acceptability measure related to user satisfaction, perceived usefulness, and acceptance. These parents’ children were patients of 4 of the 7 participating clinicians. Consistent with the planned workflow, clinicians viewed the app before seeing the patient in 4 of 9 (44%) instances. The median time spent on the app per patient was 95 (range 5-240) seconds. Think-aloud assessment results for clinicians were grouped into 2 themes: (1) trust of app vaccine results and (2) clarifying the app content. On the survey, clinicians were unanimously positive about the app, with an average System Usability Scale score of 87.5 (SE 2.5).

Conclusion

This mixed methods evaluation demonstrated that ProtectMe4 was usable and acceptable to both parents and clinicians in real-world pediatric primary care. Improved coordination among clinic staff is needed to ensure the app is consistently offered to patients and reviewed by clinicians before seeing the patient.

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

✪ The pathway to delivering injectable CAB for HIV prevention: strategies from global PrEP leaders leveraging an adapted version of the Intervention Scalability Assessment Tool (ISAT)

Authors:

Lauren R. Violette, Kidist Zewdie, Nyawira Gitahi, Kristin Beima-Sofie, & Renee Heffron

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

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

Abstract:

Background

Longer-acting cabotegravir (CAB) is a novel, safe, and efficacious pre-exposure prophylaxis (PrEP) for HIV prevention. As we near a time for CAB scale-up, the experience of global leaders in PrEP research and implementation can be leveraged to identify optimal strategies for scaling and integrating CAB into existing PrEP infrastructure worldwide.

Methods

We recruited leaders of HIV prevention clinical trials and large PrEP programs through a combination of purposive and snowball sampling for participation in individual interviews. We conducted interviews using a semi-structured guide that compared CAB to oral PrEP and sought perspectives on barriers and strategies for CAB scale-up. Interviews were conducted virtually, audio recorded, and transcribed. We used thematic analysis, grounded in an adapted version of the Intervention Scalability Assessment Tool (ISAT), to identify critical elements for optimizing delivery of CAB.

Results

From October 2021 to April 2022, we interviewed 30 participants with extensive experience in PrEP research, care, and programming. Participants worked in all seven WHO regions and reported a median of 20 years working in HIV and 10 years in PrEP. Participants agreed that CAB was efficacious and discrete, therefore having the potential to address current concerns about oral PrEP adherence and stigma. Participants indicated direct and indirect costs for provider training, expansion of existing medical infrastructure, and the current medication cost of CAB as major concerns for roll out. The true cost to the end-user and health system were unknown. There were some conflicting strategies on how to best address product targeting, presentation of efficacy, and timing of product availability with scale-up. Some thought that targeting CAB for the general population could normalize PrEP and decrease stigma, while others thought that prioritizing key populations could optimize impact by targeting those with highest risk. Overall, participants emphasized that to ensure successful CAB scale-up, communities and stakeholders must be involved at every stage of planning and implementation.

Conclusions

Our evaluation found that although there is a clear and urgent need for additional HIV PrEP options beyond daily oral PrEP, CAB scale-up must be thoughtful, flexible, and based in lessons learned from oral PrEP rollout.

Contributions to the literature
  • We used the Intervention Scalability Assessment Tool (ISAT), a quantitative tool used to inform decision-making for the scale-up of health interventions, as a framework for a qualitative analysis.
  • To our knowledge, this is the first use of the ISAT to assess scalability of injectable cabotegravir (CAB) for HIV pre-exposure prophylaxis (PrEP).
  • Our findings offer a summary of perspectives from global HIV PrEP leaders, experts, and advocates that can be used to map the process of CAB implementation using existing HIV prevention infrastructure.

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

✪ Implementation of collaborative care for depression in VA HIV clinics: Translating Initiatives for Depression into Effective Solutions (HITIDES): protocol for a cluster-randomized type 3 hybrid effectiveness-implementation trial

Authors:

Jacob T. Painter, Jeffrey Pyne, Geoffrey Curran, Rebecca A. Raciborski, Shane Russell, John Fortney, Allen L. Gifford, Michael Ohl & Eva N. Woodward

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

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

Abstract:

Background

Depression is the most diagnosed mental health condition among people living with HIV. Collaborative care is an effective intervention for depression, typically delivered in primary care settings. The HIV Translating Initiatives for Depression into Effective Solutions (HITIDES) clinical intervention involves a depression care team housed off-site that supports depression care delivery by HIV care providers. In a randomized controlled trial, HITIDES significantly improved depression symptoms for veterans living with HIV and delivered cost savings. However, no HIV clinics in the Veterans Health Administration (VHA) have implemented HITIDES; as such, it is unclear what implementation strategies are necessary to launch and sustain this intervention.

Methods

This hybrid type-3 effectiveness-implementation trial examines the implementation and effectiveness of HITIDES in 8 VHA HIV clinics randomly assigned to one of two implementation arms. Each arm uses a different implementation strategy package. Arm 1 includes an intervention operations guide; an on-site clinical champion who, with the help of a peer community of practice, will work with local clinicians and leadership to implement HITIDES at their site; and patient engagement in implementation tools. Arm 2 includes all strategies from Arm 1 with assistance from an external facilitator. The primary implementation outcomes is reach; secondary outcomes include adoption, implementation dose, depressive symptoms, and suicidal ideation. We will conduct a budget impact analysis of the implementation strategy packages. We hypothesize that Arm 2 will be associated with greater reach and adoption and that Arm 1 will be less costly.

Discussion

Preliminary work identified implementation strategies acceptable to veterans living with HIV and HIV care providers; however, the effectiveness and cost of these strategies are unknown. While the depression care team can deliver services consistently with high quality, the ability of the depression care team to engage with HIV care providers at sites is unknown. Findings from this study will be used to inform selection of implementation strategies for a broad rollout to enhance depression and suicide care for people living with HIV.

Trial registration

ClinicalTrials.gov ID: NCT05901272, Registered 10 May 2023, https://clinicaltrials.gov/study/NCT05901272

Contributions to the literature

  • It is well-recognized that those with HIV infections need greater access to mental healthcare for depression. But it is not known how best to support deployment of evidence-based mental healthcare to them.
  • This paper describes an implementation trial to roll out depression care in HIV clinics.
  • With the fragmentation of care among so many subspecialties, understanding how to roll out mental health support across specialty medical settings is crucial.
  • Results will be relevant to mental health and suicide support not only for those with HIV but across many sectors of care for adults receiving care in specialty medical settings.

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

✪ A research agenda to advance the study of implementation mechanisms

Authors:

Cara C. Lewis, Hannah E. Frank, Gracelyn Cruden, Bo Kim, Aubyn C. Stahmer, Aaron R. Lyon, Bianca Albers, Gregory A. Aarons, Rinad S. Beidas, Brian S. Mittman, Bryan J. Weiner, Nate J. Williams, Byron J. Powell & MNoE Group

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

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

Abstract:

Background

Implementation science scholars have made significant progress identifying factors that enable or obstruct the implementation of evidence-based interventions, and testing strategies that may modify those factors. However, little research sheds light on how or why strategies work, in what contexts, and for whom. Studying implementation mechanisms—the processes responsible for change—is crucial for advancing the field of implementation science and enhancing its value in facilitating equitable policy and practice change. The Agency for Healthcare Research and Quality funded a conference series to achieve two aims: (1) develop a research agenda on implementation mechanisms, and (2) actively disseminate the research agenda to research, policy, and practice audiences. This article presents the resulting research agenda, including priorities and actions to encourage its execution.

Method

Building on prior concept mapping work, in a semi-structured, 3-day, in-person working meeting, 23 US-based researchers used a modified nominal group process to generate priorities and actions for addressing challenges to studying implementation mechanisms. During each of the three 120-min sessions, small groups responded to the prompt: “What actions need to be taken to move this research forward?” The groups brainstormed actions, which were then shared with the full group and discussed with the support of facilitators trained in structured group processes. Facilitators grouped critical and novel ideas into themes. Attendees voted on six themes they prioritized to discuss in a fourth, 120-min session, during which small groups operationalized prioritized actions. Subsequently, all ideas were collated, combined, and revised for clarity by a subset of the authorship team.

Results

From this multistep process, 150 actions emerged across 10 priority areas, which together constitute the research agenda. Actions included discrete activities, projects, or products, and ways to shift how research is conducted to strengthen the study of implementation mechanisms.

Conclusions

This research agenda elevates actions to guide the selection, design, and evaluation of implementation mechanisms. By delineating recommended actions to address the challenges of studying implementation mechanisms, this research agenda facilitates expanding the field of implementation science, beyond studying what works to how and why strategies work, in what contexts, for whom, and with which interventions.

Contributions to the literature
  • This research agenda operationalizes a set of activities to strengthen the implementation science field’s focus on why and how strategies work.
  • The research agenda addresses the following activities: accumulating knowledge, innovating methods and overcoming design challenges, improving measurement, providing guidance for specifying causal mechanisms, increasing focus on theorizing, engaging the policy and practice community, engaging funders, building capacity, enhancing equity, and effectively disseminating methods.
  • Studying implementation mechanisms can promote pragmatic strategy development, equitable processes and outcomes, and policy relevance by clarifying pathways for overcoming contextually specific barriers and achieving outcomes of interest.

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

✪ Changing hearts and minds: theorizing how, when, and under what conditions three social influence implementation strategies work

Authors:

Bryan J Weiner, Rosemary D Meza, Predrag Klasnja, Rebecca Lengnick-Hall, Gretchen J Buchanan, Aaron R Lyon, Kayne D Mettert, Marcella H Boynton, Byron J Powell, and Cara C Lewis

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal Frontiers in Health Services

Abstract:

Background

Opinion leadership, educational outreach visiting, and innovation championing are commonly used strategies to address barriers to implementing innovations and evidence-based practices in healthcare settings. Despite voluminous research, ambiguities persist in how these strategies work and under what conditions they work well, work poorly, or work at all. The current paper develops middle-range theories to address this gap.

Methods

Conceptual articles, systematic reviews, and empirical studies informed the development of causal pathway diagrams (CPDs). CPDs are visualization tools for depicting and theorizing about the causal process through which strategies operate, including the mechanisms they activate, the barriers they address, and the proximal and distal outcomes they produce. CPDs also clarify the contextual conditions (i.e., preconditions and moderators) that influence whether, and to what extent, the strategy's causal process unfolds successfully. Expert panels of implementation scientists and health professionals rated the plausibility of these preliminary CPDs and offered comments and suggestions on them.

Findings

Theoretically, opinion leadership addresses potential adopters' uncertainty about likely consequences of innovation use (determinant) by promoting positive attitude formation about the innovation (mechanism), which results in an adoption decision (proximal outcome), which leads to innovation use (intermediate outcome). As this causal process repeats, penetration, or spread of innovation use, occurs (distal outcome). Educational outreach visiting addresses knowledge barriers, attitudinal barriers, and behavioral barriers (determinants) by promoting critical thinking and reflection about evidence and practice (mechanism), which results in behavioral intention (proximal outcome), behavior change (intermediate outcome), and fidelity, or guideline adherence (distal outcome). Innovation championing addresses organizational inertia, indifference, and resistance (determinants) by promoting buy-in to the vision, fostering a positive implementation climate, and increasing collective efficacy (mechanisms), which leads to participation in implementation activities (proximal outcome), initial use of the innovation with increasing skill (intermediate outcome) and, ultimately, greater penetration and fidelity (distal outcomes). Experts found the preliminary CPDs plausible or highly plausible and suggested additional mechanisms, moderators, and preconditions, which were used to amend the initial CPD.

Discussion

The middle-range theories depicted in the CPDs furnish testable propositions for implementation research and offer guidance for selecting, designing, and evaluating these social influence implementation strategies in both research studies and practice settings.

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

✪ Integrating causal pathway diagrams into practice facilitation to address colorectal cancer screening disparities in primary care

Authors:

Brooke Ike, Ashley Johnson, Rosemary Meza, & Allison Cole

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

Read the full text in the open access journal BMC Health Services Research

Abstract:

Background

Colorectal cancer (CRC) is the second leading cause of cancer death and the second most common cancer diagnosis among the Hispanic population in the United States. However, CRC screening prevalence remains lower among Hispanic adults than among non-Hispanic white adults. To reduce CRC screening disparities, efforts to implement CRC screening evidence-based interventions in primary care organizations (PCOs) must consider their potential effect on existing screening disparities. More research is needed to understand how to leverage existing implementation science methodologies to improve health disparities. The Coaching to Improve Colorectal Cancer Screening Equity (CoachIQ) pilot study explores whether integrating two implementation science tools, Causal Pathway Diagrams and practice facilitation, is a feasible and effective way to address CRC screening disparities among Hispanic patients.

Methods

We used a quasi-experimental, mixed methods design to evaluate feasibility and assess initial signals of effectiveness of the CoachIQ approach. Three PCOs received coaching from CoachIQ practice facilitators over a 12-month period. Three non-equivalent comparison group PCOs received coaching during the same period as participants in a state quality improvement program. We conducted descriptive analyses of screening rates and coaching activities.

Results

The CoachIQ practice facilitators discussed equity, facilitated prioritization of QI activities, and reviewed CRC screening disparities during a higher proportion of coaching encounters than the comparison group practice facilitator. While the mean overall CRC screening rate in the comparison PCOs increased from 34 to 41%, the mean CRC screening rate for Hispanic patients did not increase from 30%. In contrast, the mean overall CRC screening rate at the CoachIQ PCOs increased from 41 to 44%, and the mean CRC screening rate for Hispanic patients increased from 35 to 39%.

Conclusions

The CoachIQ program merges two implementation science methodologies, practice facilitation and causal pathway diagrams, to help PCOs focus quality improvement efforts on improving CRC screening while also reducing screening disparities. Results from this pilot study demonstrate key differences between CoachIQ facilitation and standard facilitation, and point to the potential of the CoachIQ approach to decrease disparities in CRC screening.

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