NCT06061328

Project OASIS: Optimizing Approaches to Select Implementation Strategies

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,020 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Barriers that prevent healthcare methods supported by science from being adopted in the real world have led to low-quality, inequitable medical care. Implementation science aims to bridge the evidence-to-practice gap but still lacks simple and convenient methods to identify implementation barriers, systematically track which strategies work to improve care, and provide accessible data and expert recommendations to guide implementation strategy selection for use in research and practice. Project OASIS (Optimizing Approaches to Select Implementation Strategies) will conduct a hybrid type-III, cluster-randomized trial of a new decision aid tool that matches site variables and barriers to successful implementation strategies.

Detailed description

Implementation science aims to improve the uptake of evidence-based health care practices (EBPs) by defining barriers that prevent their use, offering strategies to overcome these barriers, and developing methods that help clinicians and researchers choose strategies that best address the barriers they encounter. With strategy selection often being inefficient and idiosyncratic, experts have called for methods to make strategy selection scientific, data-driven, and "precise." This "precision implementation" causes a critical need to identify implementation barriers and facilitators quickly and uniformly, track implementation strategy use and effectiveness, and incorporate data and expert knowledge into the process of matching strategies to barriers. Without these improvements, there is a risk of perpetuating implementation failures and health care disparities. Project OASIS (Optimizing Approaches to Select Implementation Strategies) will conduct a cluster-randomized, hybrid type III trial to compare a machine learning derived decision aid (DA) for selecting implementation strategies with a current expert opinion-based tool in 20 VA medical centers. The investigators will apply the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework and assess rates of hepatocellular carcinoma screening (an EBP) for Veterans with cirrhosis at these sites. As this is a facility-level intervention, Veterans with cirrhosis will be cluster randomized to the DA vs. Current Tool arms. The investigators anticipate that Veterans at sites in the DA arm will be significantly more likely to receive screening than Veterans at sites in the Current Tool arm.

Conditions

• Cirrhosis
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BEHAVIORAL	OASIS DA training	The OASIS decision aid is a novel implementation strategy selection tool developed by a multidisciplinary team of experts using machine learning algorithms and user-centered design approaches.
BEHAVIORAL	Current DA Tool training	The CFIR-ERIC Matching Tool is a currently available decision aid tool for selecting implementation strategies that is based on expert opinion.

Timeline

• Start date: 2024-02-01
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2023-09-29
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States