Jessica E Ma, Marie Haverfield, Karl A Lorenz, David B Bekelman, Cati Brown-Johnson, Natalie Lo, Mary Beth Foglia, Jill S Lowery, Anne M Walling, & Karleen F Giannitrapani
University of Washington affiliated authors are displayed in bold.
Published: June 2021
Julie E. Richards, Gregory E. Simon, Jennifer M. Boggs, Rinad Beidas, Bobbi Jo H. Yarborough, Karen J. Coleman, Stacy A. Sterling, Arne Beck, Jean P. Flores, Cambria Bruschke, Julie Goldstein Grumet, Christine C. Stewart, Michael Schoenbaum, Joslyn Westphal, & Brian K. Ahmedani
University of Washington affiliated authors are displayed in bold.
Published: May 2021
Suicide rates continue to rise across the United States, galvanizing the need for increased suicide prevention and intervention efforts. The Zero Suicide (ZS) model was developed in response to this need and highlights four key clinical functions of high-quality health care for patients at risk of suicide. The goal of this quality improvement study was to understand how six large health care systems operationalized practices to support these functions—identification, engagement, treatment and care transitions.
Using a key informant interview guide and data collection template, researchers who were embedded in each health care system cataloged and summarized current and future practices supporting ZS, including, (1) the function addressed; (2) a description of practice intent and mechanism of intervention; (3) the target patient population and service setting; (4) when/how the practice was (or will be) implemented; and (5) whether/how the practice was documented and/or measured. Normalization process theory (NPT), an implementation evaluation framework, was applied to help understand how ZS had been operationalized in routine clinical practices and, specifically, what ZS practices were described by key informants (coherence), the current state of norms/conventions supporting these practices (cognitive participation), how health care teams performed these practices (collective action), and whether/how practices were measured when they occurred (reflexive monitoring).
The most well-defined and consistently measured ZS practices (current and future) focused on the identification of patients at high risk of suicide. Stakeholders also described numerous engagement and treatment practices, and some practices intended to support care transitions. However, few engagement and transition practices were systematically measured, and few treatment practices were designed specifically for patients at risk of suicide.
The findings from this study will support large-scale evaluation of the effectiveness of ZS implementation and inform recommendations for implementation of high-quality suicide-related care in health care systems nationwide.
Many individuals see a health care provider prior to death by suicide, therefore health care organizations have an important role to play in suicide prevention. The Zero Suicide model is designed to address four key functions of high-quality care for patients at risk of suicide: (1) identification of suicide risk via routine screening/assessment practices, (2) engagement of patients at risk in care, (3) effective treatment, and (4) care transition support, particularly after hospitalizations for suicide attempts. Researchers embedded in six large health care systems, together caring for nearly 11.5 million patients, are evaluating the effectiveness of the Zero Suicide model for suicide prevention. This evaluation focused on understanding how these systems had implemented clinical practices supporting Zero Suicide. Researchers collected qualitative data from providers, administrators, and support staff in each system who were responsible for implementation of practices supporting Zero Suicide. Normalization process theory, an implementation evaluation framework, was applied following data collection to: (A) help researchers catalog all Zero Suicide practices described, (B) describe the norms/conventions supporting these practices, (C) describe how health care teams were performing these practices, and (D) describe how practices were being measured. The findings from this evaluation will be vital for measuring the effectiveness of different Zero Suicide practices. This work will also provide a blueprint to help health care leaders, providers, and other stakeholders “normalize” new and existing suicide prevention practices in their own organizations.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Edward Kariithi, Monisha Sharma, Emily Kemunto, Harison Lagat, George Otieno, Beatrice M. Wamuti, David A. Katz, Christopher Obong'o, Paul Macharia, Rose Bosire, Sarah Masyuko, Mary Mugambi, Carol E. Levin, Wenjia Liu, Unmesha Roy Paladhi, Bryan J. Weiner, & Carey Farquhar
University of Washington affiliated authors are displayed in bold.
Published: May 2021
Despite the effective scale-up of HIV testing and treatment programs, only 75% of people living with HIV (PLWH) globally know their status, and this rate is lower among men. This highlights the importance of implementing HIV testing and linkage interventions with a high uptake in this population. In a cluster randomized controlled trial conducted in Kenya between 2013 and 2015, we found that assisted partner services (APS) for HIV-exposed partners of newly diagnosed PLWH safely reached more HIV-exposed individuals with HIV testing compared with client referral alone. However, more data are needed to evaluate APS implementation in a real-world setting.
This study aims to evaluate the effectiveness, acceptability, fidelity, and cost of APS when integrated into existing HIV testing services (HTS) in Western Kenya.
Our study team from the University of Washington and PATH is integrating APS into 31 health facilities in Western Kenya. We are enrolling females newly diagnosed with HIV (index clients) who consent to receiving APS, their male sexual partners, and female sexual partners of male sexual partners who tested HIV positive. Female index clients and sexual partners testing HIV positive will be followed up at 6 weeks, 6 months, and 12 months postenrollment to assess linkage to care, antiretroviral therapy initiation, and HIV viral load suppression. We will evaluate the acceptability, fidelity, and cost of real-world implementation of APS via in-depth interviews conducted with national, county, and subcounty-level policy makers responsible for HTS. Facility health staff providing HTS and APS, in addition to staff working with the study project team, will also be interviewed. We will also conduct direct observations of facility infrastructure and clinical procedures and extract data from the facilities and county and national databases.
As of March 2020, we have recruited 1724 female index clients, 3201 male partners, and 1585 female partners. We have completed study recruitment as well as 6-week (2936/2973, 98.75%), 6-month (1596/1641, 97.25%), and 12-month (725/797, 90.9%) follow-up visits. Preliminary analyses show that facilities scaling up APS identify approximately 12-18 new HIV-positive males for every 100 men contacted and tested. We are currently completing the remaining follow-up interviews and incorporating an HIV self-testing component into the study in response to the COVID-19 pandemic.
The results will help bridge the gap between clinical research findings and real-world practice and provide guidance regarding optimal strategies for APS integration into routine HIV service delivery.
DERR1-10.2196/27262
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Lisa V. Ibañez, Sabine Scott, Wendy L. Stone
University of Washington affiliated authors are displayed in bold.
Published: May 2021
Emily M. Godfrey, Anna E. Fiastro, Elizabeth A. Jacob-Files, Francine M. Coeytaux, Elisa S. Wells, Molly R. Ruben, Sajal S. Sanan, & Ian M. Bennett
University of Washington affiliated authors are displayed in bold.
Published: April 2021
Emily R. Haines, Alex Dopp, Aaron R. Lyon, Holly O. Witteman, Miriam Bender, Gratianne Vaisson, Danielle Hitch, & Sarah Birken
University of Washington affiliated authors are displayed in bold.
Published: April 2021
Attempting to implement evidence-based practices in contexts for which they are not well suited may compromise their fidelity and effectiveness or burden users (e.g., patients, providers, healthcare organizations) with elaborate strategies intended to force implementation. To improve the fit between evidence-based practices and contexts, implementation science experts have called for methods for adapting evidence-based practices and contexts and tailoring implementation strategies; yet, methods for considering the dynamic interplay among evidence-based practices, contexts, and implementation strategies remain lacking. We argue that harmonizing the three can be facilitated by user-centered design, an iterative and highly stakeholder-engaged set of principles and methods.
This paper presents a case example in which we used a three-phase user-centered design process to design and plan to implement a care coordination intervention for young adults with cancer. Specifically, we used usability testing to redesign and augment an existing patient-reported outcome measure that served as the basis for our intervention to optimize its usability and usefulness, ethnographic contextual inquiry to prepare the context (i.e., a comprehensive cancer center) to promote receptivity to implementation, and iterative prototyping workshops with a multidisciplinary design team to design the care coordination intervention and anticipate implementation strategies needed to enhance contextual fit.
Our user-centered design process resulted in the Young Adult Needs Assessment and Service Bridge (NA-SB), including a patient-reported outcome measure and a collection of referral pathways that are triggered by the needs young adults report, as well as implementation guidance. By ensuring NA-SB directly responded to features of users and context, we designed NA-SB for implementation, potentially minimizing the strategies needed to address misalignment that may have otherwise existed. Furthermore, we designed NA-SB for scale-up; by engaging users from other cancer programs across the country to identify points of contextual variation which would require flexibility in delivery, we created a tool intended to accommodate diverse contexts.
User-centered design can help maximize usability and usefulness when designing evidence-based practices, preparing contexts, and informing implementation strategies—in effect, harmonizing evidence-based practices, contexts, and implementation strategies to promote implementation and effectiveness.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Yih-Ing Hser, Allison J. Ober, Alex R. Dopp, Chunqing Lin, Katie P. Osterhage, Sarah E. Clingan, Larissa J. Mooney, Megan E. Curtis, Lisa A. Marsch, Bethany McLeman, Emily Hichborn, Laurie S. Lester, Laura-Mae Baldwin, Yanping Liu, Petra Jacobs, & Andrew J. Saxon
University of Washington affiliated authors are displayed in bold.
Published: April 2021
Telemedicine (TM) enabled by digital health technologies to provide medical services has been considered a key solution to increasing health care access in rural communities. With the immediate need for remote care due to the COVID-19 pandemic, many health care systems have rapidly incorporated digital technologies to support the delivery of remote care options, including medication treatment for individuals with opioid use disorder (OUD). In responding to the opioid crisis and the COVID-19 pandemic, public health officials and scientific communities strongly support and advocate for greater use of TM-based medication treatment for opioid use disorder (MOUD) to improve access to care and have suggested that broad use of TM during the pandemic should be sustained.
Nevertheless, research on the implementation and effectiveness of TM-based MOUD has been limited. To address this knowledge gap, the National Drug Abuse Treatment Clinical Trials Network (CTN) funded (via the NIH HEAL Initiative) a study on Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD; CTN-0102) to investigate the implementation and effectiveness of adding TM-based MOUD to rural primary care for expanding access to MOUD. In preparation for this large-scale, randomized controlled trial incorporating TM in rural primary care, a feasibility study is being conducted to develop and pilot test implementation procedures.
In this commentary, we share some of our experiences, which include several challenges, during the initial two-month period of the feasibility study phase. While these challenges could be due, at least in part, to adjusting to the COVID-19 pandemic and new workflows to accommodate the study, they are notable and could have a substantial impact on the larger, planned pragmatic trial and on TM-based MOUD more broadly. Challenges include low rates of identification of risk for OUD from screening, low rates of referral to TM, digital device and internet access issues, workflow and capacity barriers, and insurance coverage. These challenges also highlight the lack of empirical guidance for best TM practice and quality remote care models.
With TM expanding rapidly, understanding implementation and demonstrating what TM approaches are effective are critical for ensuring the best care for persons with OUD.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Jennifer H. Tang, Jennifer S. Smith, Shannon McGue, Luis Gadama, Victor Mwapasa, Effie Chipeta, Jobiba Chinkhumba, Erik Schouten, Bagrey Ngwira, Ruanne Barnabas, Mitch Matoga, Maganizo Chagomerana & Lameck Chinula
University of Washington affiliated authors are displayed in bold.
Published: April 2021
Cervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi’s public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.
We designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.
Our trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.
ClinicalTrials.gov identifier: NCT04286243. Registered on February 26, 2020.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Elizabeth A. Baker, Stephanie K. Brewer, Julie Sarno Owens, Clayton R. Cook, & Aaron R. Lyon
University of Washington affiliated authors are displayed in bold.
Published: April 2021
Stephanie D. Roche, Njeri Wairimu, Peter Mogere, Kevin Kamolloh, Josephine Odoyo, Zachary A. Kwena, Elizabeth A. Bukusi, Kenneth Ngure, Jared M. Baeten, & Katrina F. Ortblad
University of Washington affiliated authors are displayed in bold.
Published: April 2021
As countries scale up pre-exposure prophylaxis (PrEP) for HIV prevention, diverse PrEP delivery models are needed to expand access to populations at HIV risk that are unwilling or unable to access clinic-based PrEP care. To identify factors that may influence implementation of retail pharmacy-based PrEP delivery in Kenya, we conducted in-depth interviews with 40 pharmacy clients, 16 pharmacy providers, 16 PrEP clients, and 10 PrEP providers from two provinces. Most participants expressed strong support for expanding PrEP to retail pharmacies, though conditioned their acceptance on assurances that care would be private, respectful, safe, and affordable. Participant-reported determinants of feasibility centered primarily on ensuring that the intervention is compatible with retail pharmacy operations (e.g., staffing levels, documentation requirements). Future research is needed to develop and test tailored packages of implementation strategies that are most effective at integrating PrEP delivery into routine pharmacy practice in Kenya and other high HIV prevalence settings.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**