Pragmatic Measurement Archives - Page 2 of 2 - Implementation Science at UW

✪ Integrating HPV self-collect into primary care to address cervical cancer screening disparities

Abstract:

Human papillomavirus (HPV) self-collect shows promise to increase cervical cancer screening rates in underscreened populations, such as Somali patients, but little is known about how to integrate such an approach in primary care. In this study, primary care providers and staff who provide primary care services to Somali women were asked for their views on integrating HPV self-collect into routine care to address cervical cancer screening disparities. Thirty primary care providers and staff participated in semi-structured interviews exploring their views on HPV self-collect and their anticipated needs or barriers to implementing this approach into the clinic generally and with specific patient populations, such as Somali women. A thematic analysis using the constructivist version of grounded theory was undertaken. Providers and staff anticipate positive patient reaction to the option of HPV self-collect, and were interested in using this approach both for Somali patients and for all patients in general. HPV self-collect was viewed as straightforward to integrate into existing clinic workflows. Providers largely lacked awareness of the evidence supporting primary HPV testing and HPV self-collect specifically, sharing concerns about effectiveness of self-collect and the lack of a physical exam. Providers felt clinic-wide staff education and patient education, along with strategies to address disparities, such as cultural and linguistic tailoring would be needed for successful implementation. Integrating HPV self-collect as an option in the cervical cancer screening process in a primary care clinical encounter offers considerable opportunity to address health disparities and may benefit all patients

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

✪ Protocol for a hybrid type 3 effectiveness-implementation trial of a pragmatic individual-level implementation strategy for supporting school-based prevention programming

Abstract:

Background

For approximately one in five children who have social, emotional, and behavioral (SEB) challenges, accessible evidence-based prevention practices (EBPPs) are critical. In the USA, schools are the primary setting for children’s SEB service delivery. Still, EBPPs are rarely adopted and implemented by front-line educators (e.g., teachers) with sufficient fidelity to see effects. Given that individual behavior change is ultimately required for successful implementation, focusing on individual-level processes holds promise as a parsimonious approach to enhance impact.

Beliefs and Attitudes for Successful Implementation in Schools for Teachers (BASIS-T) is a pragmatic, multifaceted pre-implementation strategy targeting volitional and motivational mechanisms of educators’ behavior change to enhance implementation and student SEB outcomes. This study protocol describes a hybrid type 3 effectiveness-implementation trial designed to evaluate the main effects, mediators, and moderators of the BASIS-T implementation strategy as applied to Positive Greetings at the Door, a universal school-based EBPP previously demonstrated to reduce student disruptive behavior and increase academic engagement.

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

✪ Dissemination and implementation analysis of the Ross procedure in adults: Time to update the guidelines?

Abstract:

Background

The science of dissemination and implementation (D&I) aims to improve the quality and effectiveness of care by addressing the challenges of incorporating research and evidence-based practice into routine clinical practice. This lens of D&I has challenged the interpretation and incorporation of data, noting that failure of a given therapy may not reflect lack of efficacy, but instead reflect an imperfect implementation. The aim of this manuscript is to review the influence of the Ross procedure’s historical context on its D&I.

Method

A contextual baseline of the Ross procedure was defined from the procedure’s original description in the literature to major publications since the 2017 valvular heart disease guidelines. D&I evaluation was conducted using the Consolidated Framework for Implementation Research (CFIR), using constructs from each of the five respective domains to define the main determinants.

Results

Each of the five CFIR domains appears to be correlated with a factor influencing the Ross procedure’s varied history of enthusiasm and acceptance. The complex nature of Ross required adaptation for optimization, with a strong correlation of center volume on outcomes that were not considered in non-contemporary studies. Outcomes later published from those studies influenced social and cultural contexts within the aortic surgery community, and led to further organizational uncertainty, resulting in slow guideline incorporation.

Conclusion

The D&I of the Ross procedure was a result of inadequate appreciation of technical complexity, effect of patient selection, and complex aortic surgery experience, resulting in dismissal of an efficacious procedure due to a misunderstanding of effectiveness

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

✪ Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial

Abstract:

Background

Sepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement developed sepsis “bundles” (goals to accomplish over a specific time period) to facilitate SSC guideline implementation in clinical practice. Using the SSC 3-h bundle as a base, the Centers for Medicare and Medicaid Services developed a 3-h sepsis bundle that has become the national standard for early management of sepsis. Emerging observational data, from an analysis conducted for the AIMS grant application, suggest there may be additional mortality benefit from even earlier implementation of the 3-h bundle, i.e., the 1-h bundle.

Method

The primary aims of this randomized controlled trial are to: (1) examine the effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and (2) examine the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle. This study will be entirely conducted in the Emergency Department at 18 sites. A secondary aim is to identify clinical sepsis phenotypes and their impact on treatment outcomes.

Discussion

This cluster-randomized trial, employing implementation science methodology, is timely and important to the field. The hybrid effectiveness-implementation design is likely to have an impact on clinical practice in sepsis management by providing a rigorous evaluation of the 1- and 3-h bundles.

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

✪ Econometric evaluation of implementing a behavioral health integration intervention in primary care settings

Abstract:

Integrated behavioral health (IBH) is an approach to patient care that brings medical and behavioral health providers (BHPs) together to address both behavioral and medical needs within primary care settings. A large, pragmatic, national study aimed to test the effectiveness and measure the implementation costs of an intervention to improve IBH integration within primary care practices (IBH-PC). Assess the time and cost to practices of implementing a comprehensive practice-level intervention designed from the perspective of clinic owners to move behavioral service integration from co-location toward full integration as part of the IBH-PC study. IBH-PC program implementation costs were estimated in a representative sample of 8 practices using standard micro-econometric evaluation of activities outlined in the implementation workbook, including program implementation tasks, remote quality improvement coaching services, educational curricula, and learning community activities, over a 24-month period. The total median cost of implementing the IBH-PC program across all stages was $20,726 (range: $12,381 - $60,427). The median cost of the Planning Stage was $10,258 (range: $4,625 - $14,840), while the median cost of the Implementation Stage was $9,208 (range: $6,017 – 49,993). There were no statistically significant differences in practice or patient characteristics between the 8 selected practices and the larger IBH-PC practice sample (N=34). This study aimed to quantify the relative costs associated with integrating behavioral health into primary care. Although the cost assessment approach did not include all costs (fixed, variable, operational, and opportunity costs), the study aimed to develop a replicable and pragmatic measurement process with flexibility to adapt to emerging developments in each practice environment, providing a reasonable ballpark estimate of costs associated with implementation to help guide future executive decisions.

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

✪ Co-developed implementation guidelines to maximize acceptability, feasibility, and usability of mobile phone supervision in Kenya

Abstract:

Opportunities exist to leverage mobile phones to replace or supplement in-person supervision of lay counselors. However, contextual variables, such as network connectivity and provider preferences, must be considered. Using an iterative and mixed methods approach, we co-developed implementation guidelines to support the implementation of mobile phone supervision with lay counselors and supervisors delivering a culturally adapted trauma-focused cognitive behavioral therapy in Western Kenya. Guidelines were shared and discussed with lay counselors in educational outreach visits led by supervisors. We evaluated the impact of guidelines and outreach on the acceptability, feasibility, and usability of mobile phone supervision. Guidelines were associated with significant improvements in acceptability and usability of mobile phone supervision. There was no evidence of a significant difference in feasibility. Qualitative interviews with lay counselors and supervisors contextualized how guidelines impacted acceptability and feasibility – by setting expectations for mobile phone supervision, emphasizing importance, increasing comfort, and sharing strategies to improve mobile phone supervision. Introducing and discussing co-developed implementation guidelines significantly improved the acceptability and usability of mobile phone supervision. This approach may provide a flexible and scalable model to address challenges with implementing evidence-based practices and implementation strategies in lower-resourced areas.

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

✪ Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis

Abstract:

Background

Over the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and implementation studies have natural areas of overlap, particularly relating to the goal of using clinical trial data to leverage health care system policy changes. Few investigations have addressed pragmatic and implementation science randomized trial methods development while also considering policy impact.

Methods

The investigation used the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) and PRECIS-2-Provider Strategies (PRECIS-2-PS) tools to evaluate the design of two multisite randomized clinical trials that targeted patient-level effectiveness outcomes, provider-level practice changes and health care system policy. Seven raters received PRECIS-2 training and applied the tools in the coding of the two trials. Descriptive statistics were produced for both trials, and PRECIS-2 wheel diagrams were constructed. Interrater agreement was assessed with the Intraclass Correlation (ICC) and Kappa statistics. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) qualitative approach was applied to understanding integrative themes derived from the PRECIS-2 ratings and an end-of-study policy summit.

Results

The ICCs for the composite ratings across the patient and provider-focused PRECIS-2 domains ranged from 0.77 to 0.87, and the Kappa values ranged from 0.25 to 0.37, reflecting overall fair-to-good interrater agreement for both trials. All four PRECIS-2 wheels were rated more pragmatic than explanatory, with composite mean and median scores ≥ 4. Across trials, the primary intent-to-treat analysis domain was consistently rated most pragmatic (mean = 5.0, SD = 0), while the follow-up/data collection domain was rated most explanatory (mean range = 3.14–3.43, SD range = 0.49–0.69). RAPICE field notes identified themes related to potential PRECIS-2 training improvements, as well as policy themes related to using trial data to inform US trauma care system practice change; the policy themes were not captured by the PRECIS-2 ratings.

Conclusions

The investigation documents that the PRECIS-2 and PRECIS-2-PS can be simultaneously used to feasibly and reliably characterize clinical trials with patient and provider-level targets. The integration of pragmatic and implementation science clinical trial research methods can be furthered by using common metrics such as the PRECIS-2 and PRECIS-2-PS. Future study could focus on clinical trial policy research methods development.

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

Authors:

✪ Open Access

Read the full text in the open access journal Preventative Medicine Reports

Abstract:

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Authors:

✪ Open Access

Read the full text in the open access journal The cardiothoracic surgeon

Abstract:

Background

Method

Results

Conclusion

Authors:

✪ Open Access

Read the full text in the open access journal Trials

Abstract:

Abstract:

Background

Method

Discussion

Authors:

✪ Open Access

Read the full text in the open access journal Translational Behavioral Medicine

Abstract:

Authors:

✪ Open Access

Read the full text in the open access journal Cambridge Prisms: Global Mental Health

Abstract:

Authors:

✪ Open Access

Read the full text in the open access journal Trials

Abstract:

Background

Methods

Results

Conclusions

Authors: