Dave L. Dixon, Garima Sharma, Pratik B. Sandesara, Eugene Yang, Lynne T. Braun, George A. Mensah, Laurence S. Sperling, Prakash C. Deedwania, & Salim S. Virani
University of Washington affiliated authors are displayed in bold.
Published: October 2019
Jennifer Leeman, Barbara Baquero, Miriam Bender, Mimi Choy-Brown, Linda K. Ko, Per Nilsen, Mary Wangen, Sarah A. Birken
University of Washington affiliated authors are displayed in bold.
Published: September 2019
Aaron R Lyon, Sean A Munson, Brenna N Renn, David C Atkins, Michael D Pullmann, Emily Friedman, & Patricia A Areán
University of Washington affiliated authors are displayed in bold.
Published: September 2019
This paper presents the protocol for the National Institute of Mental Health (NIMH)–funded University of Washington’s ALACRITY (Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness) Center (UWAC), which uses human-centered design (HCD) methods to improve the implementation of evidence-based psychosocial interventions (EBPIs). We propose that usability—the degree to which interventions and implementation strategies can be used with ease, efficiency, effectiveness, and satisfaction—is a fundamental, yet poorly understood determinant of implementation.
We present a novel Discover, Design/Build, and Test (DDBT) framework to study usability as an implementation determinant. DDBT will be applied across Center projects to develop scalable and efficient implementation strategies (eg, training tools), modify existing EBPIs to enhance usability, and create usable and nonburdensome decision support tools for quality delivery of EBPIs.
Stakeholder participants will be implementation practitioners/intermediaries, mental health clinicians, and patients with mental illness in nonspecialty mental health settings in underresourced communities. Three preplanned projects and 12 pilot studies will employ the DDBT model to (1) identify usability challenges in implementing EBPIs in underresourced settings; (2) iteratively design solutions to overcome these challenges; and (3) compare the solution to the original version of the EPBI or implementation strategy on usability, quality of care, and patient-reported outcomes. The final products from the center will be a streamlined modification and redesign model that will improve the usability of EBPIs and implementation strategies (eg, tools to support EBPI education and decision making); a matrix of modification targets (ie, usability issues) that are both common and unique to EBPIs, strategies, settings, and patient populations; and a compilation of redesign strategies and the relative effectiveness of the redesigned solution compared to the original EBPI or strategy.
The UWAC received institutional review board approval for the three separate studies in March 2018 and was funded in May 2018.
The outcomes from this center will inform the implementation of EBPIs by identifying cross-cutting features of EBPIs and implementation strategies that influence the use and acceptability of these interventions, actively involving stakeholder clinicians and implementation practitioners in the design of the EBPI modification or implementation strategy solution and identifying the impact of HCD-informed modifications and solutions on intervention effectiveness and quality.
ClinicalTrials.gov NCT03515226 (https://clinicaltrials.gov/ct2/show/NCT03515226), NCT03514394 (https://clinicaltrials.gov/ct2/show/NCT03514394), and NCT03516513 (https://clinicaltrials.gov/ct2/show/NCT03516513).
DERR1-10.2196/14990
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Desmond Kuupiel, Vitalis Bawontuo, Paul K. Drain, Nonjabulo Gwala, & Tivani P. Mashamba-Thompson
University of Washington affiliated authors are displayed in bold.
Published: July 2019
World Health Organization (WHO) has created an essential list of in-vitro diagnostics. Supply chain management (SCM) is said to be the vehicle that ensures that developed point-of-care (POC) tests reach their targeted settings for use. We therefore, mapped evidence on SCM of and accessibility to POC testing (availability and use of POC tests) in low- and middle-income countries (LMICs).
We conducted a systematic scoping review using Arksey and O’Malley’s framework as a guide. We searched PubMed; CINAHL; MEDLINE; WEB of Science; Science Direct; and Google Scholar databases for studies that focused on POC diagnostic tests and SCM. The review included studies that were undertaken in 140 countries defined by the World Bank as LMICs published up to August 2017. Two reviewers independently screened the abstracts and full articles against the eligibility criteria. The study used the mixed methods appraisal tool version 2011 to assess the risk of bias for the included studies. NVivo version 11 was employed to extract themes from all included studies and results presented using a narrative approach.
Of 292 studies identified in this review, only 15 published between 2009 and 2017 included evidence on POC diagnostics and SCM. Of the 15 studies, three were conducted in Zambia, one each in Mozambique, Uganda, Guatemala; South Africa, one in Burkina Faso, Zimbabwe, and one multi-country study (Tanzania, Uganda, China, Peru and Zambia and Brazil). Six studies were not country specific since they were not primary studies. Majority of the studies reported stock-outs of HIV, syphilis, and malaria POC tests. There was a moderate to substantial level of agreement between the reviewers’ responses at full article screening stage (Kappa statistic = 0.80, p < 0.01). Nine studies underwent methodological quality appraisal and all, scored between 90 and 100%.
The results demonstrated limited published research on SCM of and accessibility to POC testing in LMICs. Further studies aimed at investigating SCM of POC tests in resource-limited settings to identify the barriers/challenges and provide a context-specific evidence-based solutions for policy/decision makers, implementers, and POC developers, funders, and development partners would be essential.
CRD42016043711
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Jordan A. Albritton, Bruce Fried, Kavita Singh, Bryan J. Weiner, Bryce Reeve, & Jeffrey R. Edwards
University of Washington affiliated authors are displayed in bold.
Published: June 2019
As lower-income countries look to develop a mature healthcare workforce and to improve quality and reduce costs, they are increasingly turning to quality improvement (QI), a widely-used strategy in higher-income countries. Although QI is an effective strategy for promoting evidence-based practices, QI interventions often fail to deliver desired results. This failure may reflect a problem with implementation. As the key implementing unit of QI, teams are critical for the success or failure of QI efforts. Thus, we used the model of work-team learning to identify factors related to the effectiveness of newly-formed hospital-based QI teams in Ghana.
This was a cross-sectional, observational study. We used structural equation modeling to estimate relationships between coaching-oriented team leadership, perceived support for teamwork, team psychological safety, team learning behavior, and QI implementation. We used an observer-rated measure of QI implementation, our outcome of interest. Team-level factors were measured using aggregated survey data from 490 QI team members, resulting in a sample size of 122 teams. We assessed model fit and tested significance of standardized parameters, including direct and indirect effects.
Learning behavior mediated a positive relationship between psychological safety and QI implementation (β = 0.171, p = 0.001). Psychological safety mediated a positive relationship between team leadership and learning behavior (β = 0.384, p = 0.068). Perceived support for teamwork did not have a significant effect on psychological safety or learning behavior.
Psychological safety and learning behavior are key for the success of newly formed QI teams working in lower-income countries. Organizational leaders and implementation facilitators should consider these leverage points as they work to establish an environment where QI and other team-based activities are supported and encouraged.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Beverly B. Green, Gloria D. Coronado, Malaika Schwartz, Jen Coury, & Laura-Mae Baldwin
University of Washington affiliated authors are displayed in bold.
Published: May 2019
Few previous studies have applied the hybrid effectiveness-implementation design framework to illustrate the way in which an intervention was progressively implemented and evaluated across multiple studies in diverse settings.
We describe the design components and methodologies of three studies that sought to improve rates of colorectal cancer (CRC) screening using mailed outreach, and apply domains put forth by Curran et al.: research aims, research questions, comparison conditions, sample, evaluation methods, measures, and potential challenges.
The Hybrid 1 study (emphasis on effectiveness) was a patient-level randomized trial of a mailed fecal test and stepped phone-outreach intervention program delivered in an integrated healthcare system (21 clinics, 4673 patients). The primary outcome was effectiveness (CRC screening uptake). Implementation outcomes included cost-effectiveness and acceptability.
The Hybrid 2 study (shared emphasis on effectiveness and implementation) was a pragmatic cluster-randomized trial of mailed fecal immunochemical test (FIT) outreach implemented at safety net clinics (26 clinics, 41,000 patients). The intervention used electronic health record tools (adapted from Hybrid 1) and clinic personnel to deliver the intervention. Outcomes included effectiveness (FIT completion) and implementation (FIT kits delivered, clinic barriers and facilitators, cost-effectiveness).
Hybrid 3 study (emphasis on implementation) is a demonstration project being conducted by two Medicaid/Medicare insurance plans (2 states, 12,000 patients) comparing two strategies for implementing mailed FIT programs that addressed Hybrid 2 implementation barriers. Outcomes include implementation (activities delivered, barriers) and effectiveness (FIT completion).
The effectiveness-implementation typology successfully identified a number of distinguishing features between the three studies. Two additional features, program design and program delivery, varied across our studies, and we propose adding them to the current typology. Program design and program delivery reflect the process by which and by whom a program is designed and delivered (e.g., research staff vs. clinic/health plan staff).
We describe three studies that demonstrate the hybrid effectiveness to implementation continuum and make recommendations for expanding the hybrid typology to include new descriptive features. Additional comparisons of Hybrid 1, 2, and 3 studies may help confirm whether our hybrid typology refinements are generalizable markers of the pipeline from research to practice.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Nami Kawakyu, Ruth Nduati, Khátia Munguambe, Joana Coutinho, Nancy Mburu, Georgina DeCastro, Celso Inguane, Andrew Zunt, Neil Abburi, Kenneth Sherr, & Sarah Gimbel
University of Washington affiliated authors are displayed in bold.
Published: March 2019
Prevention of mother-to-child HIV transmission (PMTCT) care cascade failures drive pediatric HIV infections in sub-Saharan Africa. As nurses’ clinical and management role in PMTCT expand, decision-support tools for nurses are needed to facilitate identification of cascade inefficiencies and solutions. The mobile phone–based PMTCT cascade analysis tool (mPCAT) provides health facility staff a quick summary of the number of patients and percentage drop-off at each step of the PMCTC care cascade, as well as how many women-infant pairs would be retained if a step was optimized.
The objective of this study was to understand and improve the mPCAT’s core usability factors and assess the health workers’ experience with using the mPCAT.
Overall, 2 rounds of usability testing were conducted with health workers from 4 clinics and leading experts in maternal and child health in Kenya and Mozambique using videotaped think aloud assessment techniques. Semistructured group interviews gauged the understanding of mPCAT’s core usability factors, based on the Nielsen Usability Framework, followed by development of cognitive demand tables describing the needed mPCAT updates. Post adaptation, feasibility was assessed in 3 high volume clinics over 12 weeks. Participants completed a 5-point Likert questionnaire designed to measure ease of use, convenience of integration into work, and future intention to use the mPCAT. Focus group discussions with nurse participants at each facility and in-depth interviews with nurse managers were also conducted to assess the acceptability, use, and recommendations for adaptations of the mPCAT.
Usability testing with software engineers enabled real-time feedback to build a tool following empathic design principles. The revised mPCAT had improved navigation and simplified data entry interface, with only 1 data entry field per page. Improvements to the results page included a data visualization feature and the ability to share results through WhatsApp. Coding was simplified to enable future revisions by nontechnical staff—critical for context-specific adaptations for scale-up. Health care workers and facility managers found the tool easy to use (mean=4.3), used the tool very often (mean=4.1), and definitely intended to continue to use the tool (mean=4.8). Ease of use was the most common theme identified, with emphasis on how the tool readily informed system improvement decision making.
The mPCAT was well accepted by frontline health workers and facility managers. The collaborative process between software developer and user led to the development of a more user-friendly, context-specific tool that could be easily integrated into routine clinical practice and workflow. The mPCAT gave frontline health workers and facility managers an immediate, direct, and tangible way to use their clinical documentation and routinely reported data for decision making for their own clinical practice and facility-level improvements.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Kenneth Sherr, Kristjana Ásbjörnsdóttir, Jonny Crocker, Joana Coutinho, Maria de Fatima Cuembelo, Esperança Tavede, Nélia Manaca, Keshet Ronen, Felipe Murgorgo, Ruanne Barnabas, Grace John-Stewart, Sarah Holte, Bryan J. Weiner, James Pfeiffer & Sarah Gimbel
University of Washington affiliated authors are displayed in bold.
Published: April 2019
The introduction of option B+ — rapid initiation of lifelong antiretroviral therapy regardless of disease status for HIV-infected pregnant and breastfeeding women — can dramatically reduce HIV transmission during pregnancy, birth, and breastfeeding. Despite significant investments to scale-up Option B+, results have been mixed, with high rates of loss to follow-up, sub-optimal viral suppression, continued pediatric HIV transmission, and HIV-associated maternal morbidity. The Systems Analysis and Improvement Approach (SAIA) cluster randomized trial demonstrated that a package of systems engineering tools improved flow through the prevention of mother-to-child HIV transmission (PMTCT) cascade. This five-step, facility-level intervention is designed to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). This protocol describes a novel model for SAIA delivery (SAIA-SCALE) led by district nurse supervisors (rather than research nurses), and evaluation procedures, to serve as a foundation for national scale-up.
The SAIA-SCALE stepped wedge trial includes three implementation waves, each 12 months in duration. Districts are the unit of assignment, with four districts randomly assigned per wave, covering all 12 districts in Manica province, Mozambique. In each district, the three highest volume health facilities will receive the SAIA-SCALE intervention (totaling 36 intervention facilities). The RE-AIM framework will guide SAIA-SCALE’s evaluation. Reach describes the proportion of clinics and population in Manica province reached, and sub-groups not reached. Effectiveness assesses impact on PMTCT process measures and patient-level outcomes. Adoption describes the proportion of districts/clinics adopting SAIA-SCALE, and determinants of adoption using the Organizational Readiness for Implementing Change (ORIC) tool. Implementation will identify SAIA-SCALE core elements and determinants of successful implementation using the Consolidated Framework for Implementation Research (CFIR). Maintenance describes the proportion of districts sustaining the intervention. We will also estimate the budget and program impact from the payer perspective for national scale-up.
SAIA packages user-friendly systems engineering tools to guide decision-making by frontline health workers, and to identify low-cost, contextually appropriate PMTCT improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial is designed to test a model for national intervention scale-up.
ClinicalTrials.gov NCT03425136 (registered 02/06/2018).
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Theresa J. Hoeft, Heather Wilcox, Ladson Hinton & Jürgen Unützer
University of Washington affiliated authors are displayed in bold.
Published: April 2019
Collaborative care is an evidence-based program for treating depression in primary care. We sought to expand this model by recruiting clinics interested in incorporating community partners (i.e., community-based organizations (CBO) and/or family members) in the care team. Seven sites implemented evidence-based collaborative care programs with community partners while collecting information on costs of implementing and sustaining programs.
Sites retrospectively collected data on planning and implementation costs with technical assistance from study researchers. Sites also prospectively collected cost of care activities over a 1-month period once the program was implemented to determine resources needed to sustain programs. Personnel salary costs were adjusted, adding 30% for benefits and 30% for administrative overhead.
The programs implemented varied considerably in staffing, involvement of care partners, and allocation of costs. Total planning and implementation costs varied from $39,280 to $60,575. The largest implementation cost category involved workflow development and ranged from $16,325 to $31,375 with the highest costs in this category attributed to the most successful implementation among clinic-CBO programs. Following implementation, cost per patient over the 1-month period ranged from $154 to $544. Ongoing strategic decision-making and administrative costs, which were included in cost of care, ranged from $284 to $2328 for the month.
Sites implemented collaborative care through differing partnerships, staffing, and related costs. Costs to implement and sustain programs developed in partnership are often not collected but are crucial to understanding financial aspects of developing sustainable partnerships. Assessing such costs is feasible and can inform future partnership efforts.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**
Richard R. Owen, Eva N. Woodward, Karen L. Drummond, Tisha L. Deen, Karen Anderson Oliver, Nancy J. Petersen, Scott S. Meit, John C. Fortney, & JoAnn E. Kirchner
University of Washington affiliated authors are displayed in bold.
Published: March 2019
Integrating mental health providers into primary care clinics improves access to and outcomes of mental health care. In the Veterans Health Administration (VA) Primary Care Mental Health Integration (PCMHI) program, mental health providers are co-located in primary care clinics, but the implementation of this model is challenging outside large VA medical centers, especially for rural clinics without full mental health staffing. Long wait times for mental health care, little collaboration between mental health and primary care providers, and sub-optimal outcomes for rural veterans could result. Telehealth could be used to provide PCMHI to rural clinics; however, the clinical effectiveness of the tele-PCMHI model has not been tested. Based on evidence that implementation facilitation is an effective implementation strategy to increase uptake of PCMHI when delivered on-site at larger VA clinics, it is hypothesized that this strategy may also be effective with regard to ensuring adequate uptake of the tele-PCMHI model at rural VA clinics.
This study is a hybrid type 2 pragmatic effectiveness-implementation trial of tele-PCMHI in six sites over 24 months. Tele-PCMHI, which will be delivered by clinical staff available in routine care settings, will be compared to usual care. Fidelity to the care model will be monitored but not controlled. We will use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to evaluate the patient-level clinical effectiveness of tele-PCMHI in rural VA clinics and also to evaluate the fidelity to and outcomes of the implementation strategy, implementation facilitation. The proposed study will employ a stepped-wedge design in which study sites sequentially begin implementation in three steps at 6-month intervals. Each step will include (1) a 6-month period of implementation planning, followed by (2) a 6-month period of active implementation, and (3) a final period of stepped-down implementation facilitation.
This study will evaluate the effectiveness of PCMHI in a novel setting and via a novel method (clinical video telehealth). We will test the feasibility of using implementation facilitation as an implementation strategy to deploy tele-PCMHI in rural VA clinics.
ClinicalTrials.gov registration number NCT02713217. Registered on 18 March 2016.
**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**