Project OASIS: Optimizing Approaches to Select Implementation Strategies

Hepatocellular Carcinoma Clinical Trial

— OASIS  

Official title:

Project OASIS: Optimizing Approaches to Select Implementation Strategies

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06061328
• Other study ID #: IIR 22-033
• Secondary ID: 1I01HX003610-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: October 31, 2027

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8020
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatocellular Carcinoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Ann Arbor Healthcare System, VA Palo Alto Health Care System, VA Pittsburgh Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Acceptability of Intervention Measure (AIM)	Acceptability refers to a given innovation being perceived as agreeable, palatable, or satisfactory by implementation stakeholders. The AIM is a 4-item measure scored on a 5-point Likert scale.	up to 4 weeks, 6 months post-intervention
Secondary	Intervention Appropriateness Measure (IAM)	Appropriateness is the perceived fit of an innovation to address a particular issue or problem. The IAM is a 4-item measure on a 5-point Likert scale.	up to 4 weeks, 6 months post-intervention
Secondary	Feasibility of Intervention Measure (FIM)	Feasibility refers to the extent to which an innovation can be successfully used within a given setting. The FIM is a 4-item measure on a 5-point Likert scale.	up to 4 weeks, 6 months post-intervention