Clinical trial NCT06061328: Project OASIS: Optimizing Approaches to Select Implementation Strategies
Official title: Project OASIS: Optimizing Approaches to Select Implementation Strategies
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cirrhosis
Hepatocellular Carcinoma
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Pittsburgh Healthcare System
name: VA Palo Alto Health Care System
First posted: 2023-09-29
Enrollment: 8020
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reach as assessed by hepatocellular carcinoma (HCC) screening rates
timeFrame: measured quarterly 1 year pre-intervention through 6 months post-intervention
measure: Effectiveness as assessed by patient outcomes
timeFrame: measured quarterly 1 year pre-intervention through 6 months post-intervention
measure: Adoption as assessed by % improvement in HCC screening performance
timeFrame: measured quarterly 1 year pre-intervention through 6 months post-intervention
measure: Implementation as assessed by fidelity to HCC screening recommendations
timeFrame: measured quarterly 1 year pre-intervention through 6 months post-intervention
measure: Maintenance as assessed by maintenance of other measures
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Acceptability of Intervention Measure (AIM)
timeFrame: up to 4 weeks, 6 months post-intervention
measure: Intervention Appropriateness Measure (IAM)
timeFrame: up to 4 weeks, 6 months post-intervention
measure: Feasibility of Intervention Measure (FIM)
timeFrame: up to 4 weeks, 6 months post-intervention
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Shari S Rogal, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: