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A Guide to Implementation Science for Phase 3 Clinical Trialists: Designing Trials for Evidence Uptake

Authors:

Harriette G.C. Van Spall, Laura Desveaux, Tracy Finch, Cara C. Lewis, George A. Mensah, Yves Rosenberg, Kavita Singh, Francois Venter, Bryan J. Weiner, Faiez Zannad

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: November 2024

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

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review

Authors:

Terren Green, Hayden B. Bosworth, Gloria D. Coronado, Lynn DeBar, Beverly B. Green, Susan S. Huang, Jeffrey G. Jarvik, Vincent Mor, Douglas Zatzick, Kevin P. Weinfurt & Devon K. Check

University of Washington affiliated authors are displayed in bold.

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Published: January 2024

Read the full text in the Journal of General Internal Medicine

✪ 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

✪ De-implementing and sustaining an intervention to eliminate nursing home resident bed and chair alarms: Interviews on leadership and staff perspectives

Authors:

Christine W. Hartmann, Christopher Gillespie, George G. Sayre, & A. Lynn Snow

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2021

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

Abstract:

Background

Improving nursing home quality of care relies partly on reducing or stopping ineffective or harmful practices, a process known as de-implementation. We know little about de-implementation in this setting. Relatively recent policy changes reclassified resident position-change (bed and chair) alarms, which monitor resident movement, as restraints. This created an optimal environment in which to study impressions of an alarm de-implementation and sustainment intervention.

Methods

This cross-sectional interview study focused on understanding participants’ experience of a quality improvement program in the Department of Veterans Affairs Community Living Centers (nursing homes). The program’s goal was to improve resident outcomes and staff communication and teamwork through, among other foci, eliminating resident position-change alarms. The Community Living Centers were located in geographically dispersed areas of the continental United States. Interview participants were leadership and staff members from seven Community Living Centers. We conducted in-depth, semi-structured qualitative interviews using a convenience sample and used a thematic analytic approach.

Results

We conducted seventeen interviews. We identified five main themes: Initiating De-implementation (compelling participants with evidence, engaging local leadership, and site-level education and training), Changing Expectations (educating staff and family members), Using Contrasting Approaches (gradual or abrupt elimination of alarms), Witnessing Positive Effects of De-implementation (reduction in resident falls, improved resident sleep, reduction in distressing behaviors, and increased resident engagement), and Staying the Course (sustainment of the initiative).

Conclusions

Findings highlight how participants overcame barriers and successfully eliminated resident position-change alarms and sustained the de-implementation through using convincing evidence for the initiative, local leadership involvement and support, and staff and family member education and engagement. These findings and the resulting three-phase process to support nursing homes' de-implementation efforts expand the de-implementation science knowledge base and provide a promising framework for other nursing home-based de-implementation initiatives.

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

De-implementing Inhaled Corticosteroids to Improve Care and Safety in COPD Treatment: Primary Care Providers’ Perspectives

Authors:

Krysttel Stryczek, Colby Lea, Chris Gillespie, George Sayre, Scott Wanner, Seppo T. Rinne, Renda Soylemez Wiener, Laura Feemster, Edmunds Udris, David H. Au, & Christian D. Helfrich

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Published: January 2020

Read the full text in the subscription access Journal of General Internal Medicine

✪ Addressing low-value pharmacological prescribing in primary prevention of CVD through a structured evidence-based and theory-informed process for the design and testing of de-implementation strategies: the DE-imFAR study

Authors:

Alvaro Sanchez, Jose Ignacio Pijoan, Susana Pablo, Marta Mediavilla, Rita Sainz de Rozas, Itxasne Lekue, Susana Gonzalez-Larragan, Gaspar Lantaron, Jon Argote, Arturo García-Álvarez, Pedro Maria Latorre, Christian D. Helfrich & Gonzalo Grandes

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2020

Read the full text in the open access journal Implementation Science

Abstract:

Background

De-implementation or abandonment of ineffective or low-value healthcare is becoming a priority research field globally due to the growing empirical evidence of the high prevalence of such care and its impact in terms of patient safety and social inefficiency. Little is known, however, about the factors, barriers, and facilitators involved or about interventions that are effective in promoting and accelerating the de-implementation of low-value healthcare. The De-imFAR study seeks to carry out a structured, evidence-based, and theory-informed process involving the main stakeholders (clinicians, managers, patients, and researchers) for the design, deployment, and assessment of de-implementation strategies for reducing low-value pharmacological prescribing.

Methods

A phase I formative study using a systematic and comprehensive framework based on theory and evidence for the design of implementation strategies—specifically, the Behavior Change Wheel (BCW)—will be conducted to design and model de-implementation strategies to favor reductions in low-value pharmacological prescribing of statins in primary prevention of cardiovascular disease (CVD) by main stakeholders (clinicians, managers, patients, and researchers) in a collegiate way. Subsequently, a phase II comparative hybrid trial will be conducted to assess the feasibility and potential effectiveness of at least one active de-implementation strategy to reduce low-value pharmacological prescribing of statins in primary prevention of CVD compared to the usual procedures for dissemination of clinical practice guidelines (“what-not-to-do” recommendations). A mixed-methods evaluation will be used: quantitative for the results of the implementation at the professional level (e.g., adoption, reach and implementation or execution of the recommended clinical practice); and qualitative to determine the feasibility and perceived impact of the de-implementation strategies from the clinicians’ perspective, and patients’ experiences related to the clinical care received.

Discussion

The DE-imFAR study aims to generate valid scientific knowledge about the design and development of de-implementation strategies using theory- and evidence-based methodologies suggested by implementation science. It will explore the effectiveness of these strategies and their acceptability among clinicians, policymakers, and patients. Its ultimate goal is to maximize the quality and efficiency of our health system by abandoning low-value pharmacological prescribing.

Trial Registration

Clinicaltrials.gov identifier: NCT04022850. Registered 17 July 2019

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

✪ Factors Influencing Primary Care Providers’ Unneeded Lumbar Spine MRI Orders for Acute, Uncomplicated Low-Back Pain: a Qualitative Study

Authors:

Andrea L. Nevedal, Eleanor T. Lewis, Justina Wu, Josephine Jacobs, Jeffrey G. Jarvik, Roger Chou, & Paul G. Barnett

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2019

Read the full text, open access in the subscription Journal of General Internal Medicine

Abstract:

Background

Clinical practice guidelines suggest that magnetic resonance imaging of the lumbar spine (LS-MRI) is unneeded during the first 6 weeks of acute, uncomplicated low-back pain. Unneeded LS-MRIs do not improve patient outcomes, lead to unnecessary surgeries and procedures, and cost the US healthcare system about $300 million dollars per year. However, why primary care providers (PCPs) order unneeded LS-MRI for acute, uncomplicated low-back pain is poorly understood.

Objective

To characterize and explain the factors contributing to PCPs ordering unneeded LS-MRI for acute, uncomplicated low-back pain.

Design

Qualitative study using semi-structured interviews.

Participants

Veterans Affairs PCPs identified from administrative data as having high or low rates of guideline-concordant LS-MRI ordering in 2016.

Approach

Providers were interviewed about their use of LS-MRI for acute, uncomplicated low-back pain and factors contributing to their decision-making. Directed content analysis of transcripts was conducted to identify and compare environmental-, patient-, and provider-level factors contributing to unneeded LS-MRI.

Key Results

Fifty-five PCPs participated (8.6% response rate). Both low (n = 33) and high (n = 22) guideline-concordant providers reported that LS-MRIs were required for specialty care referrals, but they differed in how other environmental factors (stringency of radiology utilization review, management of patient travel burden, and time constraints) contributed to LS-MRI ordering patterns. Low- and high-guideline-concordant providers reported similar patient factors (beliefs in value of imaging and pressure on providers). However, provider groups differed in how provider-level factors (guideline familiarity and agreement, the extent to which they acquiesced to patients, and belief in the value of LS-MRI) contributed to LS-MRI ordering patterns.

Conclusions

Results describe how diverse environmental, patient, and provider factors contribute to unneeded LS-MRI for acute, uncomplicated low-back pain. Prior research using a single intervention to reduce unneeded LS-MRI has been ineffective. Results suggest that multifaceted de-implementation strategies may be required to reduce unneeded LS-MRI.

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