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Implementation Evaluation of the ExPAND Trial

Cropped shot of a female nurse showing her patient something on a digital tablet
Assessing efforts to support informed decision-making for older adults with kidney failure
  • Client
    Patient-Centered Research Outcomes Institute (PCORI)
  • Dates
    2024 – 2028

Problem

George Washington University wanted to evaluate ExPAND, a program to help older adults with kidney failure make more informed treatment decisions. 

The George Washington University’s Expanding and Promoting Alternative Care and Knowledge in Decision-making (ExPAND) Trial focuses on improving treatment options for older adults with kidney failure. This $12 million PCORI-funded study aims to transform treatment decision-making for older adults with kidney failure by comparing two approaches to shared decision-making (SDM):

  • Approach 1 implements kidney disease education (KDE) programs presenting all treatment options, evidence-based decision aids, and staff trained in SDM.
  • Approach 2 adds a kidney supportive care (KSC) program providing additional palliative care support for patients choosing alternative treatment plans.

A rigorous implementation evaluation using established implementation science methodologies and frameworks is crucial to understand how these strategies function in real-world settings to inform how they can be effectively sustained and scaled. This can help potentially transform care delivery for older adults with kidney failure.

Solution

NORC is using rigorous implementation science frameworks to evaluate ExPAND.

Faced with a challenge of evaluating two complex interventions across different practice settings, NORC has designed and is implementing a comprehensive mixed-methods evaluation approach grounded in the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and Consolidated Framework for Implementation Research (CFIR). Together, these frameworks offer a rigorous yet flexible structure for evaluating both outcomes and context. As part of this ongoing effort, NORC has developed six aims:

  • Aim 1: Examine adoption of interventions
  • Aim 2: Examine contextual factors that influenced adoption of the interventions
  • Aim 3: Examine reach of interventions to patient populations
  • Aim 4: Examine implementation (i.e., fidelity) of the interventions
  • Aim 5: Examine maintenance (i.e., anticipated sustainability) of the interventions
  • Aim 6: Examine contextual factors that influenced implementation and maintenance of the interventions  

NORC’s approach is capturing both measurable outcomes and real-world barriers and facilitators of implementing the two ExPAND approaches. To accomplish this, NORC is leveraging multiple data collection methods—key informant interviews, surveys, site visits, and de-identified patient visit level data from practice sites. NORC’s approach allows for an evaluation that can uncover not just what worked, but why it worked in some settings and not in others.

By systematically assessing how these approaches are adopted, implemented, and maintained across different sites, NORC is delivering actionable insights that will enhance patient-centered care for end-stage renal disease (ESRD) patients. This effort highlights NORC’s expertise in designing and executing mixed methods evaluations that integrate implementation science frameworks to advance patient-centered clinical effectiveness research. It also underscores NORC’s strength in applying theory-driven, adaptive methods to assess and solve complex health services challenges in real-world environments.

Result

Our findings will help understand the overall impact and adoption of ExPAND and inform implementation strategies across different settings.

NORC will produce a final evaluation report that will describe the potential barriers and facilitators to the successful implementation of the two approaches of ExPAND. Specifically, it will examine differences by implementation sites, and potential impact of the interventions based on their adoption, reach, fidelity, and anticipated sustainability. 

Project Leads

“Evaluating implementation in patient-centered comparative clinical effectiveness studies is a key step for understanding the real-world potential of evidence-based interventions. NORC’s findings may support meaningful change in how treatment options are discussed with older patients with kidney failure.”

Senior Research Scientist

“Evaluating implementation in patient-centered comparative clinical effectiveness studies is a key step for understanding the real-world potential of evidence-based interventions. NORC’s findings may support meaningful change in how treatment options are discussed with older patients with kidney failure.”

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