CirrhosisOASISNCT06061328
Project OASIS: Optimizing Approaches to Select Implementation Strategies
A study testing OASIS DA training and Current DA Tool training in people with Cirrhosis and Hepatocellular Carcinoma, run by VA Office of Research and Development at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Hepatocellular Carcinoma
- What is being tested?
- OASIS DA training and Current DA Tool training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,020 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Veterans post-transplant or with active hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
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.
Read the 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
- Being tested
- OASIS DA training, Current DA Tool training
- 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
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OASIS DA trainingBehavioural
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 trainingBehavioural
The CFIR-ERIC Matching Tool is a currently available decision aid tool for selecting implementation strategies that is based on expert opinion.
| Study group | Role | What they receive |
|---|---|---|
| OASIS DA | Experimental | Half of the sites will be randomized to receive training on the OASIS decision aid. Receives: 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. Receives: Behavioral: Current DA Tool training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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.
Measured: 6 months post-intervention
Secondary outcomes (3)
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.
Measured: up to 4 weeks, 6 months post-intervention
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.
Measured: up to 4 weeks, 6 months post-intervention
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.
Measured: up to 4 weeks, 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Feb 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 8,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Pittsburgh Healthcare System, VA Palo Alto Health Care System
- Responsible party
- Sponsor
- Investigators
- Shari S Rogal, MD MPH, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061328
- Sponsor's protocol ID
- IIR 22-033
- Other IDs
- 1I01HX003610-01A2
- Acronym
- OASIS
- Status last verified
- Feb 2026
- First submitted
- 21 Sep 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project OASIS: Optimizing Approaches to Select Implementation Strategies
- ClinicalTrials.gov ID
- NCT06061328
- Acronym / sponsor ID
- OASIS / IIR 22-033
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8,020 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Pittsburgh Healthcare System, VA Palo Alto Health Care System
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| OASIS DA | Experimental | Behavioral: OASIS DA trainingHalf of the sites will be randomized to receive training on the OASIS decision aid. |
| Current DA Tool | Active comparator | Behavioral: Current DA Tool trainingHalf of the sites will be randomized to receive training on the current decision aid tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- Physicians, advance practice providers, nurses, leadership, and staff engaged with selecting and applying implementation strategies to improve care at a participating VA medical center
Key exclusion criteria (1 listed)
- Veterans post-transplant or with active hepatocellular carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OASIS DA trainingThe 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. | Behavioural | OASIS DA |
| Current DA Tool trainingThe CFIR-ERIC Matching Tool is a currently available decision aid tool for selecting implementation strategies that is based on expert opinion. | Behavioural | Current DA Tool |
Primary outcome
Reach as assessed by hepatocellular carcinoma (HCC) screening rates
Time frame: measured quarterly 1 year pre-intervention through 6 months post-intervention
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.
Effectiveness as assessed by patient outcomes
Time frame: measured quarterly 1 year pre-intervention through 6 months post-intervention
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.
Adoption as assessed by % improvement in HCC screening performance
Time frame: measured quarterly 1 year pre-intervention through 6 months post-intervention
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.
Implementation as assessed by fidelity to HCC screening recommendations
Time frame: measured quarterly 1 year pre-intervention through 6 months post-intervention
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).
Maintenance as assessed by maintenance of other measures
Time frame: 6 months post-intervention
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.
3 secondary outcomes
Acceptability of Intervention Measure (AIM)
Time frame: up to 4 weeks, 6 months post-intervention
Intervention Appropriateness Measure (IAM)
Time frame: up to 4 weeks, 6 months post-intervention
Feasibility of Intervention Measure (FIM)
Time frame: up to 4 weeks, 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shari S Rogal, MD MPH principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OASIS DA training and Current DA Tool training in people with Cirrhosis and Hepatocellular Carcinoma, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach as assessed by hepatocellular carcinoma (HCC) screening rates (time frame: measured quarterly 1 year pre-intervention through 6 months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.