Filtering by: Implementation Research
Mar
17
12:00 PM12:00
Clinical Trial Designs, Rollout, Stepped-Wedge Designs, Implementation Research

CDIAS PSMG: C. Hendricks Brown and Gregory Simon

Rollout designs in implementation research:  Often necessary and sometimes preferred.

C. Hendricks Brown, PhD
Northwestern University

Gregory Simon, MD, MPH
Kaiser Permanente Washington Health Research Institute

ABSTRACT:
Background: Rollout designs, which include stepped wedge designs, are defined by staggered implementation of new or alternative programs or services. Critiques of stepped wedge and other rollout designs have raised concerns regarding the confounding of true implementation or program effects with unrelated, global changes in service delivery, with some recommending they only be used when traditional parallel-group designs are not practicable. However, rollout designs may sometimes be more suitable than traditional parallel group designs for ethical, scientific, or practical reasons.

Results: We define and provide rationale for and examples of stepped wedge and the larger class of rollout designs, in which all participating units receive a new program or service implementation. Staged implementation in a rollout design may be necessary when denying, rather than delaying, implementation of a known effective service is ethically unacceptable. Scientifically, stepped wedge has increased statistical power relative to an equivalent parallel group design, and some rollout designs have the capability to compare different phases of implementation and sustainment. A rollout design may be practically necessary either because of limited resources and other logistical challenges or community requirements that no site serve as a control. Examples of completed and ongoing rollout trials illustrate how these ethical, scientific, and practical considerations influenced trial designs.

Conclusions: Stepped wedge and other rollout trial designs may be well suited to evaluation of implementation strategies or policy changes. In implementation trials, rollout designs may be necessary for practical reasons, may be required for ethical reasons, and may be preferred for scientific reasons. We summarize when such rollout designs have advantages and drawbacks.

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Jan
14
12:00 PM12:00
Audiences, Context, Evidence, Implementation Research

CDIAS PSMG: Ross Brownson

Revisiting Concepts of Evidence in Implementation Science

Ross Brownson, PhD
Washington University in St. Louis

ABSTRACT:
Evidence, in multiple forms, is a foundation of implementation research. For public health and clinical practice, evidence includes: Type 1 evidence on etiology and burden; Type 2 evidence on effectiveness of interventions; and Type 3: evidence on dissemination and implementation within context. Because current concepts of evidence have been relatively narrow and insufficient, this presentation will identify and discuss challenges and debates about the uses, usefulness, and gaps in evidence for implementation research. Intersecting gaps include the need to: (1) reconsider how the evidence base is determined, (2) improve understanding of contextual effects on implementation, (3) sharpen the focus on health equity in how we approach and build the evidence-base, and (4) learn from audience and stakeholder differences. Recommendations for enhancing the uses and usefulness of evidence will be presented.

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Oct
27
12:00 PM12:00
Primary Care, HIV Prevention, Intervention, Stepped-Wedge Designs, PrEP, eHealth, Implementation Research

PSMG: Innovations in Ending the HIV Epidemic Series - Parya Saberi and Wayne Steward

A tailored clinic-level intervention using a stepped-wedge design to increase PrEP uptake in primary care settings

Parya Saberi, PharmD, MAS, AAHIVP
University of California, San Francisco

Wayne Steward, PhD, MPH
University of California, San Francisco

ABSTRACT:
Lack of healthcare provider knowledge, capacity, and willingness to prescribe PrEP are barriers to PrEP delivery in clinical settings. In this presentation, we will discuss details of the PrEP Optimization Intervention (PrEP-OI) which combines a PrEP Coordinator with an online panel management tool to assist providers with PrEP uptake, persistence, and management in a large safety-net system. The intervention was rolled out at 12 primary care San Francisco Department of Public Health clinics using a stepped-wedge design preceding a follow-up phase. Additionally, we will review the challenges the study overcame with the development of PrEP-OI's technology-based component, onboarding and implementation, and response to the SARS-CoV-2 pandemic.

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