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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**

✪ Artificial Intelligence–Augmented Clinical Decision Support Systems for Pregnancy Care: Systematic Review

Authors:

Xinnian Lin, Chen Liang, Jihong Liu, Tianchu Lyu, Nadia Ghumman & Berry Campbell

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

Read the full text in the open access journal Journal of Medical Internet Research

Abstract:

Background

Despite the emerging application of clinical decision support systems (CDSS) in pregnancy care and the proliferation of artificial intelligence (AI) over the last decade, it remains understudied regarding the role of AI in CDSS specialized for pregnancy care.

Objectives

To identify and synthesize AI-augmented CDSS in pregnancy care, CDSS functionality, AI methodologies, and clinical implementation, we reported a systematic review based on empirical studies that examined AI-augmented CDSS in pregnancy care.

Methods

We retrieved studies that examined AI-augmented CDSS in pregnancy care using database queries involved with titles, abstracts, keywords, and MeSH (Medical Subject Headings) terms. Bibliographic records from their inception to 2022 were retrieved from PubMed/MEDLINE (n=206), Embase (n=101), and ACM Digital Library (n=377), followed by eligibility screening and literature review. The eligibility criteria include empirical studies that (1) developed or tested AI methods, (2) developed or tested CDSS or CDSS components, and (3) focused on pregnancy care. Data of studies used for review and appraisal include title, abstract, keywords, MeSH terms, full text, and supplements. Publications with ancillary information or overlapping outcomes were synthesized as one single study. Reviewers independently reviewed and assessed the quality of selected studies.

Results

We identified 30 distinct studies of 684 studies from their inception to 2022. Topics of clinical applications covered AI-augmented CDSS from prenatal, early pregnancy, obstetric care, and postpartum care. Topics of CDSS functions include diagnostic support, clinical prediction, therapeutics recommendation, and knowledge base.

Conclusion

Our review acknowledged recent advances in CDSS studies including early diagnosis of prenatal abnormalities, cost-effective surveillance, prenatal ultrasound support, and ontology development. To recommend future directions, we also noted key gaps from existing studies, including (1) decision support in current childbirth deliveries without using observational data from consequential fetal or maternal outcomes in future pregnancies; (2) scarcity of studies in identifying several high-profile biases from CDSS, including social determinants of health highlighted by the American College of Obstetricians and Gynecologists; and (3) chasm between internally validated CDSS models, external validity, and clinical implementation.

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

✪ Leveraging human-centered design and causal pathway diagramming toward enhanced specification and development of innovative implementation strategies: a case example of an outreach tool to address racial inequities in breast cancer screening

Authors:

Leah M. Marcotte, Raina Langevin, Bridgette H. Hempstead, Anisha Ganguly, Aaron R. Lyon, Bryan J. Weiner, Nkem Akinsoto, Paula L. Houston, Victoria Fang, & Gary Hsieh

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2024

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

Abstract:

Background

Implementation strategies are strategies to improve uptake of evidence-based practices or interventions and are essential to implementation science. Developing or tailoring implementation strategies may benefit from integrating approaches from other disciplines; yet current guidance on how to effectively incorporate methods from other disciplines to develop and refine innovative implementation strategies is limited. We describe an approach that combines community-engaged methods, human-centered design (HCD) methods, and causal pathway diagramming (CPD)—an implementation science tool to map an implementation strategy as it is intended to work—to develop innovative implementation strategies.

Methods

We use a case example of developing a conversational agent or chatbot to address racial inequities in breast cancer screening via mammography. With an interdisciplinary team including community members and operational leaders, we conducted a rapid evidence review and elicited qualitative data through interviews and focus groups using HCD methods to identify and prioritize key determinants (facilitators and barriers) of the evidence-based intervention (breast cancer screening) and the implementation strategy (chatbot). We developed a CPD using key determinants and proposed strategy mechanisms and proximal outcomes based in conceptual frameworks.

Results

We identified key determinants for breast cancer screening and for the chatbot implementation strategy. Mistrust was a key barrier to both completing breast cancer screening and using the chatbot. We focused design for the initial chatbot interaction to engender trust and developed a CPD to guide chatbot development. We used the persuasive health message framework and conceptual frameworks about trust from marketing and artificial intelligence disciplines. We developed a CPD for the initial interaction with the chatbot with engagement as a mechanism to use and trust as a proximal outcome leading to further engagement with the chatbot.

Conclusions

The use of interdisciplinary methods is core to implementation science. HCD is a particularly synergistic discipline with multiple existing applications of HCD to implementation research. We present an extension of this work and an example of the potential value in an integrated community-engaged approach of HCD and implementation science researchers and methods to combine strengths of both disciplines and develop human-centered implementation strategies rooted in causal perspective and healthcare equity.

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

✪ Stakeholder perspectives on a telemedicine referral and coordination model to expand medication treatment for opioid use disorder in rural primary care clinics

Authors:

Allison J Ober, Alex R Dopp, Sarah E Clingan, Megan E Curtis, Chunqing Lin, Stacy Calhoun, Sherry Larkins, Megan Black, Maria Hanano, Katie P Osterhage, Laura-Mae Baldwin, Andrew J Saxon, Emily G Hichborn, Lisa A Marsch, Larissa J Mooney, and Yih-Ing Hser

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published:October 2023

Read the full text in the open access journal Journal of Substance Use and Addiction Treatment

Abstract:

Introduction

Opioid overdose deaths are increasing rapidly in the United States. Medications for opioid use disorder (MOUD) are effective and can be delivered in primary care, but uptake has been limited in rural communities. Referral to and coordination with an external telemedicine (TM) vendor by rural primary care clinics for MOUD (TM-MOUD) may increase MOUD access for rural patients, but we know little about perspectives on this model among key stakeholders. As part of a TM-MOUD feasibility study, we explored TM-MOUD acceptability and feasibility among personnel and patients from seven rural primary care clinics and a TM-MOUD vendor.

Methods

We conducted virtual interviews or focus groups with clinic administrators (n = 7 interviews), clinic primary care and behavioral health providers (8 groups, n = 30), other clinic staff (9 groups, n = 37), patients receiving MOUD (n = 16 interviews), TM-MOUD vendor staff (n = 4 interviews), and vendor-affiliated behavioral health and prescribing providers (n = 17 interviews). We asked about experiences with and acceptability of MOUD (primarily buprenorphine) and telemedicine (TM) and a TM-MOUD referral and coordination model. We conducted content analysis to identify themes and participants quantitatively rated acceptability of TM-MOUD elements on a 4-item scale.

Results

Perceived benefits of vendor-based TM-MOUD included reduced logistical barriers, more privacy and less stigma, and access to services not available locally (e.g., counseling, pain management). Barriers included lack of internet or poor connectivity in patients' homes, limited communication and trust between TM-MOUD and clinic providers, and questions about the value to the clinic of TM-MOUD referral to external vendor. Acceptability ratings for TM-MOUD were generally high; they were lowest among frontline staff.

Conclusions

Rural primary care clinic personnel, TM-MOUD vendor personnel, and patients generally perceived referral from primary care to a TM-MOUD vendor to hold potential for increasing access to MOUD in rural communities. Increasing TM-MOUD uptake requires buy-in and understanding among staff of the TM-MOUD workflow, TM services offered, requirements for patients, advantages over clinic-based or TM services from clinic providers, and identification of appropriate patients. Poverty, along with patient hesitation to initiate treatment, creates substantial barriers to MOUD treatment generally; insufficient internet availability creates a substantial barrier to TM-MOUD.

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

✪ ‘I understood the texting process well’ – Participant perspectives on usability and acceptability of SMS-based telehealth follow-up after voluntary medical male circumcision in South Africa

Authors:

Jacqueline Pienaar, Sarah Day, Geoffrey Setswe, Beatrice Wasunna, Vuyolwethu Ncube, Felex Ndebele, Femi Oni, Evelyn Waweru, Calsile Khumalo, Hannock Tweya, Kenneth Sherr, Yanfang Su, and Caryl Feldacker

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2023

Read the full text in the open access journal Digital Health

Abstract:

Background

Voluntary medical male circumcision (MC) is a biomedical HIV prevention method that requires post-operative follow-up for healing confirmation. Recent research found that a two-way texting (2wT) app providing SMS-based telehealth for MC patients was safe and reduced provider workload. We evaluated 2wT usability among MC clients in South Africa assigned the 2wT intervention within a larger randomized controlled trial (RCT) of 2wT safety and workload.

Methods

This quantitative usability study is within an RCT where 547 men used 2wT to interact with an MC provider via SMS. The sub-study involved the first 100 men assigned to 2wT who completed a usability survey 14 days after surgery. Acceptability was assessed through 2wT response rates of the 547 men. Regression models analyzed associations between age, wage, location, potential adverse events (AEs), and 2wT responses.

Results

Men assigned to 2wT found it safe, comfortable, and convenient, reporting time and cost savings. High response rates (88%) to daily messages indicated acceptability. Age, wage, and location didn't affect text responses or potential AEs.

Conclusion

2wT for post-MC follow-up was highly usable and acceptable, suggesting its viability as an alternative to in-person visits. It enhanced confidence in wound self-management. This SMS-based telehealth can enhance MC care quality and be adapted to similar contexts for independent healing support, particularly for men.

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

✪ Integration of a Digital Health Intervention Into Immunization Clinic Workflows in Kenya: Qualitative, Realist Evaluation of Technology Usability

Authors:

Samantha B Dolan, Rachel Wittenauer, Jessica C Shearer, Anne Njoroge, Penina Onyango, George Owisom, William B Lober, Shan Liu, Nancy Puttkammer, & Peter Rabinowitz

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

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

Abstract:

Background

In an effort to increase vaccination coverage in low-resource settings, digital tools have been introduced to better track immunization records, improve data management practices, and provide improved access to vaccination coverage data for decision-making. Despite the potential of these electronic systems to improve the provision of health services, few digital health interventions have been institutionalized at scale in low- and middle-income countries.

Objective

In this paper, we aimed to describe how health care workers in Kenya had integrated an electronic immunization registry into their immunization clinic workflows and to use these findings to inform the development of a refined program theory on the registry’s usability.

Methods

Informed by realist methodology, we developed a program theory to explain usability of the electronic immunization registry. We designed a qualitative study based on our theory to describe the barriers and facilitators influencing data entry and use. Qualitative data were collected through semistructured interviews with users and workflow observations of immunization clinic sessions. Our findings were summarized by context-mechanism-outcome relationships formed after analyzing our key themes across interviews and workflow observations. Using these relationships, we were able to identify common rules for future implementers.

Results

Across the 12 facilities included in our study, 19 health care workers were interviewed, and 58 workflow sessions were observed. The common rules developed from our qualitative findings are as follows: rule 1—ensure that the users complete training to build familiarity with the system, understand the value of the system and data, and know where to find support; rule 2—confirm that the system captures all data needed for users to provide routine health care services and is easy to navigate; rule 3—identify work-arounds for poor network, system performance, and too few staff or resources; and rule 4—make users aware of expected changes to their workflow, and how these changes might differ over time and by facility size or number of patients. Upon study completion, we revised the program theory to reflect the importance of the goals and workflows of electronic immunization registries aligning with reality.

Conclusions

We created a deeper understanding of the underlying mechanisms for usability of the registry. We found that the electronic immunization registry had high acceptability among users; however, there were numerous barriers to using the system, even under ideal conditions, causing a misalignment between the system and the reality of the users’ workflows and their environment. Human-centered design and human-factors methods can assist during pilot stages to better align systems with users’ needs and again after scale-up to ensure that interventions are suitable for all user settings."

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

✪ Improving the Usability of Written Exposure Therapy for Therapists in the Department of Veterans Affairs Telemental Health: Formative Study Using Qualitative and User-Centered Design Methods

Authors:

Megan Moldestad, Valentina V Petrova, Katie Tirtanadi, Sonali R Mishra, Suparna Rajan, George Sayre, John C Fortney & Heather Schacht Reisinger

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

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

Abstract:

Background

User modifications are common in evidence-based psychosocial interventions (EBPIs) for mental health disorders. Often, EBPIs fit poorly into clinical workflows, require extensive resources, or pose considerable burden to patients and therapists. Implementation science is increasingly researching ways to improve the usability of EBPIs before implementation. A user-centered design can be used to support implementation methods to prioritize user needs and solutions to improve EBPI usability.

Objective

Trauma-focused EBPIs are a first-line treatment for patients with posttraumatic stress disorder (PTSD) in the Department of Veterans Affairs. Written exposure therapy (WET) is a brief, trauma-focused EBPI wherein patients handwrite about trauma associated with their PTSD. Initially developed for in-person delivery, WET is increasingly being delivered remotely, and outcomes appear to be equivalent to in-person delivery. However, there are logistical issues in delivering WET via video. In this evaluation, we explored usability issues related to WET telehealth delivery via videoconferencing software and designed a solution for therapist-facing challenges to systematize WET telehealth delivery.

Methods

In the Discover phase, both groups had challenges delivering WET and other PTSD therapies via telehealth because of technology issues with videoconferencing software, environmental distractions, and workflow disruptions. Narrative transfer (ie, patients sending handwritten trauma accounts to therapists) was the first target for design solution development as it was deemed most critical to WET delivery. In the Design and Build phase, we identified design constraints and brainstormed solution ideas. This led to the development of 3 solution workflows that were presented to a subgroup of therapist users through cognitive walkthroughs. Meetings with this subgroup allowed workflow refinement to improve narrative transfers. Finally, to facilitate using these workflows, we developed PDF manuals that are being refined in subsequent phases of the implementation project (not mentioned in this paper).

Results

In the Discover phase, both groups had challenges delivering WET and other PTSD therapies via telehealth because of technology issues with videoconferencing software, environmental distractions, and workflow disruptions. Narrative transfer (ie, patients sending handwritten trauma accounts to therapists) was the first target for design solution development as it was deemed most critical to WET delivery. In the Design and Build phase, we identified design constraints and brainstormed solution ideas. This led to the development of 3 solution workflows that were presented to a subgroup of therapist users through cognitive walkthroughs. Meetings with this subgroup allowed workflow refinement to improve narrative transfers. Finally, to facilitate using these workflows, we developed PDF manuals that are being refined in subsequent phases of the implementation project (not mentioned in this paper).

Conclusion

The Discover, Design and Build, and Test framework can be a useful tool for understanding user needs in complex EBPI interventions and designing solutions to user-identified usability issues. Building on this work, an iterative evaluation of the 3 solution workflows and accompanying manuals with therapists and patients is underway as part of a nationwide WET implementation in telehealth settings.

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

✪ Online HIV prophylaxis delivery: Protocol for the ePrEP Kenya pilot study

Authors:

Catherine Kiptinness, Paulami Naik, Nicholas Thuo, Rachel C. Malen, Julia C. Dettinger, Jillian Pintye, Maeve Rafferty, Edwin Jomo, Nicky Nyamasyo, Tony Wood, Paul Isabelli, Sarah Morris, David Hattery, Andy Stergachis, Daniel Were, Monisha Sharma, Kenneth Ngure, Melissa Latigo Mugambi, and Katrina F. Ortblad

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

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

Abstract:

Background

Online pharmacies in Kenya provide sexual and reproductive health products (e.g., HIV self-testing, contraception) and could be leveraged to increase the reach of HIV pre-exposure and post-exposure prophylaxis (PrEP/PEP) to populations who do not frequently attend health facilities. To date, evidence is limited for operationalizing online PrEP/PEP delivery and the type of populations reached with this differential service delivery model.

Methods

The ePrEP Kenya Pilot will deliver daily oral PrEP and PEP via MYDAWA, a private online pharmacy retailer, to clients in Nairobi for 18 months. Potential clients will obtain information about PrEP/PEP on MYDAWA's sexual wellness page and self-screen for HIV risk. Individuals ≥18 years, identified as at HIV risk, and willing to pay for a blood-based HIV self-test and PrEP/PEP delivery will be eligible for enrollment. To continue with online PrEP/PEP initiation, eligible clients will purchase a blood-based HIV self-test for 250 KES (~USD 2) [delivered to their setting of choice for 99 KES (~USD 1)], upload an image of their self-test result, and attend a telemedicine visit with a MYDAWA provider. During the telemedicine visit, providers will screen clients for PrEP/PEP eligibility, including clinical concerns (e.g., kidney disease), discuss self-test results, and complete counseling on PrEP/PEP use and safety. Providers will refer clients who self-test HIV positive or report any existing medical conditions to the appropriate services at healthcare facilities that meet their preferences. Eligible clients will be prescribed PrEP (30-day PrEP supply at initiation; 90-day PrEP supply at follow-up visits) or PEP (28-day supply) for free and have it delivered for 99 KES (~USD 1). We will measure PrEP and PEP initiation among eligible clients, PEP-to-PrEP transition, PrEP continuation, and implementation outcomes (e.g., feasibility, acceptability, and costs).

Discussion

Establishing pathways to increase PrEP and PEP access is crucial to help curb new HIV infections in settings with high HIV prevalence. The findings from this study will provide evidence on the implementation of online pharmacy PrEP and PEP service delivery that can help inform guidelines in Kenya and similar settings.

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

✪ Using a Clinical Workflow Analysis to Enhance eHealth Implementation Planning: Tutorial and Case Study

Authors:

Stephanie Staras, Justin S. Tauscher, Natalie Rich, Esaa Samarah, Lindsay A. Thompson, Michelle M. Vinson, Michael J. Muszynski, & Elizabeth A. Shenkman

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2021

Read the full text in the open access journal JMIR mHealth and uHealth

Abstract:

eHealth apps often fail to improve clinical outcomes due to poor integration with clinical workflow—the sequence and personnel needed to undertake a series of tasks for clinical care. Our central thesis is that eHealth interventions will be more effective if the clinical workflow is studied and taken into consideration for intervention implementation. This paper aims to provide an introductory tutorial on when and how to use a clinical workflow analysis to guide the implementation of eHealth interventions. The tutorial includes a step-by-step guide to conducting a clinical workflow analysis in planning for eHealth implementation.

We began with a description of why a clinical workflow analysis is best completed before the implementation of eHealth interventions. Next, we described 4 steps needed to perform the clinical workflow analysis: the identification of discrete workflow components, workflow assessment, triangulation, and the stakeholder proposal of intervention implementation. Finally, we presented a case study of a clinical workflow analysis, which was conducted during patient visits of patients aged 11 or 12 years from 4 diverse pediatric or family medicine clinics to plan the implementation of a tablet-based app for adolescent vaccination.

Investigators planning the implementation of new eHealth interventions in health care settings can use the presented steps to assess clinical workflow, thereby maximizing the match of their intervention with the clinical workflow. Conducting a prospective workflow study allows for evidence-based planning, identifying potential pitfalls, and increasing stakeholder buy-in and engagement. This tutorial should aid investigators in increasing the successful implementation of eHealth interventions.

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

✪ Ethics of Digital Mental Health During COVID-19: Crisis and Opportunities

Authors:

Nicole Martinez-Martin*, Ishan Dasgupta*, Adrian Carter, Jennifer A. Chandler, Philipp Kellmeyer, Karola Kreitmair, Anthony Weiss, & Laura Y. Cabrera

*These authors contributed equally

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2020

Read the full text in the open access journal JMIR Mental Health

Abstract:

Social distancing measures due to the COVID-19 pandemic have accelerated the adoption and implementation of digital mental health tools. Psychiatry and therapy sessions are being conducted via videoconferencing platforms, and the use of digital mental health tools for monitoring and treatment has grown. This rapid shift to telehealth during the pandemic has given added urgency to the ethical challenges presented by digital mental health tools. Regulatory standards have been relaxed to allow this shift to socially distanced mental health care. It is imperative to ensure that the implementation of digital mental health tools, especially in the context of this crisis, is guided by ethical principles and abides by professional codes of conduct. This paper examines key areas for an ethical path forward in this digital mental health revolution: privacy and data protection, safety and accountability, and access and fairness.

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