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Project OASIS: Optimizing Approaches to Select Implementation Strategies

NCT ID: NCT06061328

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

8020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2027-10-31

Brief Summary

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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

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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

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Cirrhosis Hepatocellular Carcinoma

Keywords

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Implementation science Implementation strategies Implementation barriers Consolidated Framework for Implementation Research Expert Recommendations for Implementing Change Precision implementation Liver cancer Early detection of cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This hybrid type III trial will compare the effectiveness and implementation of the decision aid (DA) vs. Current Tool to improve liver cancer screening for Veterans with cirrhosis in 20 VA sites, as well as assess how users make decisions based on the source of the recommendation (e.g., expert opinion vs. machine-derived). VA clinicians in both arms will receive a one-time 1-hour webinar training on either the new DA or the Current Tool. Trainers will be available to provide technical assistance after the webinars during the 6-month implementation phase but will not provide additional implementation support. Participants will be encouraged to initiate the recommended strategies within 3 months of training.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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OASIS DA

Half of the sites will be randomized to receive training on the OASIS decision aid.

Group Type EXPERIMENTAL

OASIS DA training

Intervention Type BEHAVIORAL

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.

Current DA Tool

Half of the sites will be randomized to receive training on the current decision aid tool.

Group Type ACTIVE_COMPARATOR

Current DA Tool training

Intervention Type BEHAVIORAL

The CFIR-ERIC Matching Tool is a currently available decision aid tool for selecting implementation strategies that is based on expert opinion.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Veterans:

* Veterans with two outpatient or one inpatient codes for cirrhosis or its complications who had an encounter in the prior 18 months at a participating VA medical center

VA clinicians:

* Physicians, advance practice providers, nurses, leadership, and staff engaged with selecting and applying implementation strategies to improve care at a participating VA medical center

Exclusion Criteria

* Veterans post-transplant or with active hepatocellular carcinoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Pittsburgh Healthcare System

FED

Sponsor Role collaborator

VA Palo Alto Health Care System

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shari S Rogal, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

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VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IIR 22-033

Identifier Type: -

Identifier Source: org_study_id

1I01HX003610-01A2

Identifier Type: NIH

Identifier Source: secondary_id

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