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✪ A formative mixed methods evaluation of a new Ross program: Why context matters

Authors:

Kyle S. Bilodeau, Frank F. Yang, Michael Shang, Audrey Mossman, David C. Mauchley, Scott DeRoo, & Christopher R. Burke

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2024

Read the full text in the open access journal The Cardiothoracic Surgeon

Abstract:

Background

The Ross procedure is a technically complex operation to address the pathology of the aortic valve. Prior attempts at widespread implementation have been plagued with variations in effectiveness. We report our initial programmatic outcomes using dissemination and implementation (D&I) science frameworks, with an aim to define both programmatic efficacy and effectiveness. The study design was a single center, explanatory sequential mixed methods evaluation of a Ross surgery program from June 2020 to April 2023. Quantitative measures for baseline patient characteristics and postoperative outcomes were summarized. Qualitative measures were obtained using semi-structured interviews and characterized using implementation science frameworks.

Results

A total of 71 patients underwent the Ross procedure at a single academic center. Mean age was 40 years (± 13). There were no perioperative deaths or valve-related reinterventions (0%). During the follow-up period, 2 (2.8%) patients required re-operation and 2 (2.8%) required balloon dilation of the pulmonary homograft. Qualitative measures noted communication and prospective self-audit facilitated measures of effectiveness, as dichotomy within expected vs. observed outcomes led to program modifications. Collaboration across hospital systems promoted adoption and implementation, which led to the incorporation of the Ross procedure into accepted organizational practice.

Conclusions

In this formative evaluation, limited-efficacy outcomes demonstrated similar programmatic success to data from other established centers. With the prerequisite center volume and case selection, the Ross procedure is a safe and efficacious treatment for aortic valvular disease. Implementation science can be used both in real-time and retrospectively to guide organizational efforts to improve outcomes and to improve the translation of results across centers.

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

✪ Virtual versus usual in-office care for multiple sclerosis: The VIRTUAL-MS multi-site randomized clinical trial study protocol

Authors:

Marisa McGinley, Josh J Carlson, Jennifer Reihm, Matthew Plow, Megan Roser, Nikki Sisodia, Jeffrey A Cohen, Anita D Misra-Hebert, Ann A Lazar & Riley Bove

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

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

Abstract:

Background

Multiple sclerosis (MS) affects nearly 1 million people and is estimated to cost $85.4 billion in the United States annually. People with MS have significant barriers to receiving care and telemedicine could substantially improve access to specialized, comprehensive care. In cross-sectional analyses, telemedicine has been shown to be feasible, have high patient and clinician satisfaction, reduce patient costs and burden, and enable a reasonable assessment of disability. However, no studies exist evaluating the longitudinal impact of telemedicine care for MS. Here we describe the study protocol for VIRtual versus UsuAL In-office care for Multiple Sclerosis (VIRTUAL-MS). The main objective of the study is to evaluate the impact of telemedicine for MS care on: patient clinical outcomes, economic costs, patient, and clinician experience.

Methods

This two-site randomized clinical trial will enroll 120 adults with a recent diagnosis of MS and randomize 1:1 to receive in-clinic vs. telemedicine care for 24 months. The primary outcome of the study is worsening in any one of the four Multiple Sclerosis Functional Composite 4 (MSFC4) measures at 24 months. Other study outcomes include patient and clinician satisfaction, major healthcare costs, Expanded Disability Status Scale, treatment adherence, and digital outcomes.

Conclusion

The results of this study will directly address the key gaps in knowledge about longitudinal telemedicine-enabled care in an MS population. It will inform clinical care implementation as well as design of trials in MS and other chronic conditions.

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

✪ Improving safety and preventing falls using an evidence-based, front-line staff huddling practice: protocol for a pragmatic trial to increase quality of care in State Veterans Homes, Katherine Ritchey

Authors:

Princess Nash, Valerie Clark, Eleanor McConnell, Whitney Mills, Robert Morgan, Camilla Pimentel, Katherine Ritchey, Cari Levy, A Lynn Snow, & Christine Hartmann

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Falls in nursing homes are a major cause for decreases in residents’ quality of life and overall health. This study aims to reduce resident falls by implementing the LOCK Falls Programme, an evidence-based quality improvement intervention. The LOCK Falls Programme involves the entire front-line care team in (1) focusing on evidence of positive change, (2) collecting data through systematic observation and (3) facilitating communication and coordination of care through the practice of front-line staff huddles.

Methods and analysis

The study protocol describes a mixed-methods, 4-year hybrid (type 2) effectiveness-implementation study in State Veterans Homes in the USA. The study uses a pragmatic stepped-wedge randomised trial design and employs relational coordination theory and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework to guide implementation and evaluation. A total of eight State Veterans Homes will participate and data will be collected over an 18-month period. Administrative data inclusive of all clinical assessments and Minimum Data Set assessments for Veterans with a State Veterans Home admission or stay during the study period will be collected (8480 residents total). The primary outcome is a resident having any fall. The primary analysis will be a partial intention-to-treat analysis using the rate of participants experiencing any fall. A staff survey (n=1200) and qualitative interviews with residents (n=80) and staff (n=400) will also be conducted. This research seeks to systematically address known barriers to nursing home quality improvement efforts associated with reducing falls.

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

✪ Recruiting Community Health Centers for Implementation Research: Challenges, Implications, and Potential Solutions

Authors:

April Lee, Rachel Gold, Rachel Caskey, Sadia Haider, Teresa Schmidt, Emily Ott, Rinad S. Beidas, Amritha Bhat, William Pinnock, Melinda Vredevoogd, Tess Grover, Jena Wallander Gemkow, and Ian M. Bennett

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text open access in the journal Health Equity

✪ Combining legal epidemiology and implementation science to improve global access to medicines: challenges and opportunities

Authors:

Jeff Lane & Andy Stergachis

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

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

Abstract:

Laws and policies affecting access to medicines have been in the global health spotlight for decades, yet our understanding of their effects remains substantially underdeveloped. The emerging field of legal epidemiology combined with the methods of implementation science presents an opportunity to help address this gap. Legal epidemiology refers to the scientific study and deployment of law as a factor in the cause, distribution, and prevention of disease and injury in a population. Legal epidemiology studies consist of a systematic collection and coding of laws and policies relating to a particular topic. Quasi-experimental or observational research methods can then be applied to take advantage of natural experiments resulting from heterogenous adoption and/or implementation of laws and policies.

Often legal epidemiology studies fail to account for heterogenous law implementation processes, presenting a need and opportunity to integrate implementation science methods. Researchers may face challenges in integrating these methods for access to medicines studies, including data access issues and a complex legal and implementation environment. Yet, the opportunities presented by increasingly transparent legal environments, improved monitoring of medicine availability, universal health coverage expansion, and electronic health and insurance records integration may facilitate overcoming these challenges. Improved collaboration and communication between researchers, health authorities, manufacturers, and health providers from public and private sectors will be critical. In spite of the challenges, combining the fields of legal epidemiology and implementation science may present an important strategy toward creating a legal and policy environment that supports global and equitable access to medicines.

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

✪ The Science of Precision Prevention: Research Opportunities and Clinical Applications to Reduce Cardiovascular Health Disparities

Authors:

Thomas A Pearson, Debbie Vitalis, Charlotte Pratt, Rebecca Campo, Antonis A Armoundas, David Au, Bettina Beech, Olga Brazhnik, Christopher G Chute, Karina W Davidson, Ana V Diez-Roux, Lawrence J Fine, Davera Gabriel, Peter Groenveld, Jaclyn Hall, Alison B Hamilton, Hui Hu, Heng Ji, Amy Kind, William E Kraus, Harlan Krumholz, George A Mensah, Raina M Merchant, Dariush Mozaffarian, David M Murray, Dianne Neumark-Sztainer, Maya Petersen & David Goff

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

Read the full text in the open access journal JACC: Advances

Abstract:

Precision prevention embraces personalized prevention but includes broader factors such as social determinants of health to improve cardiovascular health. The quality, quantity, precision, and diversity of data relatable to individuals and communities continue to expand. New analytical methods can be applied to these data to create tools to attribute risk, which may allow a better understanding of cardiovascular health disparities. Interventions using these analytic tools should be evaluated to establish feasibility and efficacy for addressing cardiovascular disease disparities in diverse individuals and communities. Training in these approaches is important to create the next generation of scientists and practitioners in precision prevention. This state-of-the-art review is based on a workshop convened to identify current gaps in knowledge and methods used in precision prevention intervention research, discuss opportunities to expand trials of implementation science to close the health equity gaps, and expand the education and training of a diverse precision prevention workforce.

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

✪ Supporting Psychosis Research, Implementation, and Training Through an Academic Intermediary–Purveyor Organization

Authors:

Sarah L. Kopelovich, Rachel M. Brian, Akansha Vaswani-Bye, Lydia Chwastiak, Chris McCain, Victoria Shepard, Wenqi Zhang, Mackenzie Tennison, Sarah Fikre, and Maria Monroe-DeVita

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

Read the full text open access in the journal Psychological Services

✪ Enhancing the Introduction and Scale Up of Self-Administered Injectable Contraception (DMPA-SC) in Health Systems (the EASIER Project): Protocol for Embedded Implementation Research

Authors:

Colin Baynes, Petrus S Steyn, Kenneth Sherr, and James Kiarie

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published:August 2023

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

Abstract:

Background

The introduction of self-administered injectable contraception presents an opportunity to address the unmet need for family planning. As ministries of health scale up self-administered injectable contraception, there is a scarcity of knowledge on the implementation practices and contextual conditions that help and hinder these efforts. The World Health Organization has launched the “enhancing self-administered family planning through embedded research project” (EASIER) to address this challenge.

Objective

EASIER’s objectives are to: (1) assess the coverage of self-injectable contraception, and the readiness of health systems to integrate it into the contraceptive method mix; (2) document strategies used to introduce and scale up self-injectable contraception and understand practices that have led to success and challenges; (3) identify the contextual factors that affect the adoption and implementation of self-injectable contraception throughout health systems; (4) understand whether implementation addresses users’ preferences and needs; (5) strengthen collaboration between decision makers, researchers, and implementers; support and build capacity to use evidence.

Methods

EASIER developed a global protocol that implementation research (IR) teams in Burkina Faso, Ghana, and Kenya adapted into country-level embedded IR projects. In all countries (1) at the national level, IR teams evaluate the policy environment for scaling up by conducting a desk review and in-depth interviews; (2) at the local level, IR teams implement quantitative questionnaires on structural and organizational readiness to integrate self-injection into the method mix; (3) in “case study” localities, IR teams conduct in-depth interviews and focus group discussions with implementers, method users, and community members; and (4) IR teams use participatory action research to elicit stakeholder participation and translate findings into programmatic decisions.

Results

EASIER has been launched in all 3 countries. Preliminary findings are available from Burkina Faso and Kenya. In Burkina Faso, IR teams identified the need to strengthen health worker training approaches to ensure that family planning providers at primary health care facilities are adequately oriented to depo-medroxyprogesterone acetate subcutaneous (DMPA-SC) and self-injection and capacitated to initiate women to the method. In addition, they report the need for service communication strategies that reach potential users of the method with knowledge about self-injection and how to initiate the practice. In Kenya, the findings illuminate the need for practice guidelines that county health teams can use to coordinate the rollout of self-administered DMPA-SC. In addition, Kenya’s findings underscore the importance of addressing logistical bottlenecks to help avoid stock-outs.

Conclusions

EASIER presents a strategy to embed IR in contraceptive method introduction and scale-up, address local knowledge needs, devise ways to maximize the impact of new technologies in health systems, and build capacity for using evidence in programmatic decisions. Adaptation and implementation of country-level IR studies will advance the use of IR to strengthen family planning programs.

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