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Design of a pragmatic trial integrating human papillomavirus (HPV) self-sampling into primary care to reduce cervical cancer screening disparities in Somali American individuals: The Isbaar project

Authors:

John Lin, Rachel L. Winer, Christina Bliss, Barsness, Jay Desai, Kristi Fordyce, Rahel Ghebre, Anisa M. Ibrahim, Sharif Mohamed, Timothy Ramer, Adam A. Szpiro, Bryan J. Weiner, Sophia Yohe, Rebekah Pratt

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: January 2025

Read the full text in the subscription access journal Contemporary Clinical Trials

✪ Systems analysis and improvement approach to optimize tuberculosis (SAIA-TB) screening, treatment, and prevention in South Africa: a stepped-wedge cluster randomized trial

Authors:

Brittney J. van de Water, Meredith B. Brooks, Refiloe Matji, Betty Ncanywa, Freck Dikgale, Nadia N. Abuelezam, Bulelwa Mzileni, Miyakazi Nokwe, Singilizwe Moko, Lindiwe Mvusi, Marian Loveday, & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

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

Abstract:

Background

The use of systems engineering tools, including the development and use of care cascades using routinely collected data, process mapping, and continuous quality improvement, is used for frontline healthcare workers to devise systems level change. South Africa experiences high rates of tuberculosis (TB) infection and disease as well as HIV co-infection. The Department of Health has made significant gains in HIV services over the last two decades, reaching their set “90–90-90” targets for HIV. However, TB services, although robust, have lagged in comparison for both disease and infection. The Systems Analysis and Improvement Approach (SAIA) is a five-step implementation science method, drawn from systems engineering, to identify, define, and implement workflow modifications using cascade analysis, process mapping, and repeated quality improvement cycles within healthcare facilities.

Methods

This stepped-wedge cluster randomized trial will evaluate the effectiveness of SAIA on TB (SAIA-TB) cascade optimization for patients with TB and high-risk contacts across 16 clinics in four local municipalities in the Sarah Baartman district, Eastern Cape, South Africa. We hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. Focus group discussions and key informant interviews with clinic staff will also be conducted to determine drivers of implementation variability across clinics.

Discussion

This study has the potential to improve TB screening, treatment initiation, and completion for both active disease and preventive measures among individuals with and without HIV in a high burden setting. SAIA-TB provides frontline health care workers with a systems-level view of their care delivery system with the aim of sustainable systems-level improvements.

Trial registration

Clinicaltrials.gov, NCT06314386. Registered 18 March 2024, https://clinicaltrials.gov/study/NCT06314386. NCT06314386.

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

✪ 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**

Organize and mobilize for implementation effectiveness to improve overdose education and naloxone distribution from syringe services programs: A randomized controlled trial

Authors:

Barrot H. Lambdin, Ricky N. Bluthenthal, Bryan R. Garner, Lynn D. Wenger, Erica N. Browne, Terry Morris, Lee Ongais, Cariné E. Megerian & Alex H. Kral

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal Implementation Science

Abstract:

Background

The United States (US) continues to face decades-long increases in opioid overdose fatalities. As an opioid overdose reversal medication, naloxone can dramatically reduce opioid overdose mortality rates when distributed to people likely to experience or witness an opioid overdose and packaged with education on its use, known as overdose education and naloxone distribution (OEND). Syringe services programs (SSPs) are ideal venues for OEND with staff who are culturally competent in providing services for people who are at risk of experiencing or observing an opioid overdose. We carried out a randomized controlled trial of SSPs to understand the effectiveness of the organize and mobilize for implementation effectiveness (OMIE) approach at improving OEND implementation effectiveness within SSPs

Methods

Using simple randomization, 105 SSPs were enrolled into the trial and assigned to one of two study arms — (1) dissemination of OEND best practice recommendations (Control SSPs) or the OMIE approach along with dissemination of the OEND best practice recommendations (i.e., OMIE SSPs). OMIE SSPs could participate in 60-min OMIE sessions once a month for up to 12 months. At 12-month post-baseline, 102 of 105 SSPs (97%) responded to the follow-up survey.

Results

The median number of sessions completed by OMIE SSPs was 10. Comparing OMIE SSPs to control SSPs, we observed significant increases in the number of participants receiving naloxone (incidence rate ratio: 2.15; 95% CI: 1.42, 3.25; p < 0.01) and the rate of naloxone doses distributed per SSP participant (adjusted incidence rate ratio: 1.97; 95% CI: 1.18, 3.30; p = 0.01). We observed no statistically significant difference in the number of adopted best practices between conditions (difference in means 0.2, 95% CI: − 0.7, 1.0; p = 0.68). We also observed a threshold effect where SSPs receiving a higher OMIE dose had greater effect sizes with regard to the number of people given naloxone and the number of naloxone doses distributed.

Conclusions

In conclusion, the multifaceted OMIE approach was effective at increasing naloxone distribution from SSPs, despite substantial external shocks during the trial. These findings have major implications for addressing the overdose crisis, which has continued unabated for decades.

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

✪ Drivers of success: improving implementation research tools for better health outcomes

Authors:

Quinhas Fernandes, Orvalho Augusto & Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal BMC Pediatrics

Abstract:

A thorough examination of context, and how it influences implementation of evidence-based interventions, is a promising strategy for enhancing child survival initiatives. Spreading approaches that are identified as drivers of successful reduction in under-five mortality from ‘exemplar’ countries could be pivotal in leading to reductions in other settings facing stagnant mortality rates, in particular for low- and middle-income countries with high disease burden and insufficient programmatic capacity to effectively implement evidence-based interventions at scale. Yet there remains a lack of robust analytic methods to accurately assess mortality and describe the drivers of interventions’ implementation success at both national and subnational levels. The field of implementation science and its defining targets and tools is well positioned to address this knowledge gap by integrating qualitative and quantitative research methods into an adaptable evaluation framework that can be tailored to meet the specific needs across varying country contexts. These tools enhance the measurement of population health outcomes and provide crucial evidence on implementation barriers and facilitators that can inform policies that can be adjusted for diverse contexts. This commentary aims to emphasize the role of implementation research in understanding how exemplar countries achieved significant improvements in child survival and in identifying replicable lessons for other settings. Ultimately, all manuscripts underscore the relevance of implementation research in bolstering the reduction of under-five mortality.

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

✪ Raising the issue of quality in implementation science reporting in global health: Implications for health planning and practice

Authors:

Alexandra L. Rose, Helen E. Jack, Muneera A. Rasheed, Jessica F. Magidson

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text open access in The International Journal of Health Planning and Management

Abstract:

Implementation outcomes, which focus on the barriers to, and facilitators and processes of healthcare delivery, are critical to translating research evidence to health planning and practice and to improving healthcare delivery. This article summarizes key quality issues in reporting of implementation science outcomes within global health and describes the ways in which this presents a challenge for shifting health planning and practice across low-resource health systems. This article also suggests that the wider use of reporting guidelines for implementation outcomes could help address this issue.

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

✪ Adjunctive interventions: Change methods directed at recipients that support uptake and use of health innovations

Authors:

Justin D. Smith, Dennis H. Li, James L. Merle, Brennan Keiser, Brian Mustanski & Nanette D. Benbow

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal Implementation Science

Abstract:

Background

Implementation science groups change methods into two categories: (1) clinical, behavioral, or biomedical intervention targeting recipient’s health outcomes and (2) implementation strategies targeting the delivery system. Differentiating interventions from strategies based on their intended functions is critical to accurately attributing their effects to health or implementation outcomes. However, in coordinating 200+ HIV implementation research projects and conducting systematic reviews, we identified change methods that had characteristics of both interventions and strategies that were inconsistently categorized. To alleviate confusion and improve change method specification, we propose that implementation science should adopt an extant but rarely used term—adjunctive interventions—to classify change methods that are distinct from the common intervention/strategy taxonomy

Main text

Adjunctive interventions as change methods that target recipients (e.g., patients, participants) of a health intervention but are designed to increase recipients’ motivation, self-efficacy, or capacity for initiating, adhering to, complying with, or engaging with the health intervention over time. In two of our published reviews on implementation of HIV interventions, 25 out of 45 coded change methods fell into this gray area between strategy and intervention. We also noted instances in which the same change method was labelled as the intervention (“the thing”), as an adjunctive intervention, or an implementation strategy in different studies—further muddying the waters. Adjunctive interventions are distinguished from other change methods by their intended targets, desired outcomes, and theory of action and causal processes. Whereas health interventions target recipients and have a direct, causal effect on the health outcome, adjunctive interventions enhance recipients’ attitudes and behaviors to engage with the intervention and have an indirect causal link to the health outcome via increasing the probability of recipients’ utilization and adherence to the intervention. Adjunctive interventions are incapable of directly producing the health outcome and will themselves require implementation strategies to effectively impact sustained uptake, utilization, and adherence. Case examples, logic modeling, and considerations (e.g., relationship to consumer engagement strategies) for adjunctive intervention research are provided

Conclusion

Conceptualizing adjunctive interventions as a separate type of change method will advance implementation research by improving tests of effectiveness, and the specification of mechanisms and outcomes.

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

✪ Formative Evaluation of a Comprehensive Self-Management Intervention for Irritable Bowel Syndrome, Comorbid Anxiety, and Depression: Mixed Methods Study

Authors:

Kendra Kamp, Pei-Lin Yang, Emily Friedman, Alejandra Lopez, Sarah Iribarren, Pamela Barney, Sean Munson, Margaret Heitkemper, & Rona Levy

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2023

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

Abstract:

Background

Irritable bowel syndrome (IBS) is a disorder of the gut-brain interaction that is associated with abdominal pain, altered bowel patterns, and reduced quality of life. Up to 50% of patients with IBS also report anxiety or depressive symptoms. Although effective self-management interventions exist for individuals with IBS, few have been effectively implemented, and most do not consider the unique needs of patients with comorbid IBS and anxiety or depression.

Objective

This study aimed to determine the anticipated acceptability, appropriateness, feasibility, and usability of a comprehensive self-management intervention using an implementation science and human-centered design approach among individuals with comorbid IBS and anxiety or depression and health care providers.

Methods

A convergent mixed methods design was used to elicit feedback on the comprehensive self-management intervention outline and content to identify refinement needs before testing. Patients with IBS and moderate to severe anxiety or depression and health care providers were purposefully sampled from primary care and gastroenterology settings. Participants completed semistructured interviews and surveys on anticipated acceptability, appropriateness, feasibility, and usability.

Results

Patient participants (n=12) were on average 36.8 (SD 12.2) years of age, and 42% (5/12) were currently receiving psychological therapy. Health care providers (n=14) were from primary care (n=7) and gastroenterology (n=7) settings. The mean usability scores (out of 100) were 52.5 (SD 14.5) for patients and 45.6 (SD 11.6) for providers. For patients and providers, qualitative data expanded the quantitative findings for acceptability and appropriateness. Acceptability findings were the comprehensive nature of the intervention and discussion of the gut-brain interaction. For appropriateness, participants reported that the intervention provided structure, accountability, and support. Feasibility was confirmed for patients, but there was a divergence of findings between quantitative and qualitative measures for providers. Patients focused on intervention feasibility, while providers focused on implementation feasibility in the clinic. Identified usability issues to address before implementation included the intervention delivery format, length, and lack of integration into health care settings that, if not addressed, may limit the reach of the intervention

Conclusions

Patients and health care providers found the intervention acceptable and appropriate. Several feasibility and usability issues were identified, including intervention delivery methods, length of intervention, and the best methods to implement in the clinic setting. The next steps are to refine the intervention to address the identified issues and test in a pilot study whether addressing usability issues leads to the anticipated improvements in implementation and uptake.

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

✪ The relationship between first-level leadership and inner-context and implementation outcomes in behavioral health: a scoping review

Authors:

Rosemary D. Meza, Noah S. Triplett, Grace S. Woodard, Prerna Martin, Alya N. Khairuzzaman, Gabrielle Jamora, & Shannon Dorsey

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2021

Read the full text in the open access journal Implementation Science

Abstract:

Background

First-level leadership is uniquely positioned to support evidence-based practice (EBP) implementation for behavioral health due to first-level leaders’ access to and relationship with service providers. First-level leaders are individuals who directly supervise and manage frontline employees who do not manage others. However, first-level leadership is underrepresented in existing reviews of the impact of leadership on EBP implementation. This review describes the relationship between first-level leadership and implementation determinants and outcomes.

Methods

A scoping review was performed to synthesize the literature on the relationship between first-level leadership and inner-context and implementation outcomes. A literature search was conducted in PubMed, Eric, PsycINFO, CINAHL, Scopus, and Web of Science. To be eligible, studies had to examine first-level leadership, be conducted in settings providing behavioral health services, and examine the relationship between first-level leadership and an implementation or inner-context outcome. Data extraction and synthesis were performed to describe study characteristics, leader-outcome relationships, and overlap in leadership frameworks.

Results

Twenty-one records met our inclusion criteria. Studies primarily relied on observational designs and were often cross-sectional. Studies more often examined general leadership rather than leadership strategically focused on EBP implementation (i.e., strategic implementation leadership). Our findings suggest that several forms of first-level leadership are inconsistently related to a broad set of implementation determinants, with infrequent examination of specific implementation outcomes. The broad set of implementation determinants studied, limited number of replications, and inconsistent findings have resulted in sparse evidence for any specific leadership-outcome relationship. The greatest accumulation of evidence exists for general leadership’s positive relationship with providers’ EBP attitudes, most notably in the form of transformational leadership. This was followed by evidence for strategic implementation leadership facilitating general implementation. Our synthesis revealed moderate conceptual overlap of strategic implementation leadership behaviors described in the theory of implementation leadership and theory of middle managers’ role in implementation.

Conclusions

Our findings suggest that first-level leadership may play an important role in shaping implementation determinants and outcomes, but consistent empirical support is sparse and confidence dampened by methodological issues. To advance the field, we need studies that adopt stronger methodological rigor, address the conceptual overlap in leadership frameworks, examine a broader set of implementation outcomes, and examine conditions under which leadership impacts implementation.

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

Expected Organizational Costs for Inserting Prevalence Information Into Lumbar Spine Imaging Reports

Authors:

Brian W. Bresnahan, Jeffrey G. Jarvik, Eric N. Meier, Kathryn T. James, Laura S. Gold, Sean D. Rundell, Judith A. Turner, Pradeep Suri, Patrick H. Luetmer, Janna L. Friedly, Karen J. Sherman,
Patrick J. Heagerty, David F. Kallmes, Andrew L. Avins, Brent D. Griffith, & Larry G. Kessler

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: June 2021

Read the full text in the subscription access Journal of the American College of Radiology