Project OASIS: Optimizing Approaches to Select Implementation Strategies

NCT06061328 | Enrolling By Invitation DMC

• 2 other identifiers: IIR 22-0331I01HX003610-01A2
• Study Type: interventional
• Target: 8,020
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma; Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Reach as assessed by hepatocellular carcinoma (HCC) screening rates

  Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of active VA patients with a diagnosis of cirrhosis receiving guideline-concordant abdominal imaging every 6 months.

  measured quarterly 1 year pre-intervention through 6 months post-intervention

• Effectiveness as assessed by patient outcomes

  Effectiveness is the impact of an intervention on important individual outcomes. Patient outcomes such as cancers detected and linkage to curative treatment will be used to assess effectiveness.

  measured quarterly 1 year pre-intervention through 6 months post-intervention

• Adoption as assessed by % improvement in HCC screening performance

  Adoption is the absolute number, proportion, and representativeness of settings/people who are willing to initiate a program. The investigators will assess adoption by the percent improvement in screening performance at intervention sites from pre- to post-intervention.

  measured quarterly 1 year pre-intervention through 6 months post-intervention

• Implementation as assessed by fidelity to HCC screening recommendations

  Implementation is the extent to which an intervention is delivered as intended. The investigators will assess implementation by the proportion of patients at an intervention site receiving all hepatocellular carcinoma screening as recommended (correct timing and modality).

  measured quarterly 1 year pre-intervention through 6 months post-intervention

• Maintenance as assessed by maintenance of other measures

  Maintenance is the extent to which a program becomes part of routine organizational practices. The investigators will assess maintenance by sustainment of all above outcomes at 6 months post-intervention.

  6 months post-intervention

Secondary Outcomes (3)

• Acceptability of Intervention Measure (AIM)

  up to 4 weeks, 6 months post-intervention

• Intervention Appropriateness Measure (IAM)

  up to 4 weeks, 6 months post-intervention

• Feasibility of Intervention Measure (FIM)

  up to 4 weeks, 6 months post-intervention

Study Arms (2)

OASIS DA

EXPERIMENTAL

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

Behavioral: OASIS DA training

Current DA Tool

ACTIVE COMPARATOR

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

Behavioral: Current DA Tool training

Interventions

OASIS DA training 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.

OASIS DA

Current DA Tool training BEHAVIORAL

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

Current DA Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Veterans post-transplant or with active hepatocellular carcinoma

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Pittsburgh Healthcare System: collaborator
• VA Palo Alto Health Care System: collaborator

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Fibrosis; Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Shari S Rogal, MD MPH

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 29, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)