Implementation Strategy Training for Liver Cancer

(OASIS Trial)

Overseen By Shari S Rogal, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Post-transplant, Hepatocellular carcinoma

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to better implement trusted medical practices to improve liver cancer care at VA medical centers. It tests two training methods—one using a new decision aid tool called OASIS and the other using the current decision aid tool—to determine which more effectively helps clinicians choose the best strategies for patient care. Veterans who have experienced cirrhosis (liver scarring) or its complications and have recently visited a participating VA medical center are good candidates. The research aims to make healthcare more consistent and fair by improving the implementation of medical strategies. As an unphased trial, this study offers veterans the opportunity to contribute to enhancing healthcare delivery and ensuring fair treatment practices.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this decision aid tool training is safe?

Research has shown that decision-support tools, such as the OASIS DA training, are generally safe. These tools guide medical decisions without causing physical harm. While specific data on the safety of OASIS DA training is lacking, studies on similar tools indicate they are safe and well-tolerated.

The OASIS DA training targets healthcare provider training, so participants should not anticipate medical risks. Reports of negative effects from similar decision-support tools have not emerged, suggesting their safety.

Overall, participating in training like OASIS DA seems to be a low-risk method to enhance healthcare practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve decision-making strategies for liver cancer treatment through innovative training methods. The OASIS decision aid training offers a fresh approach by potentially enhancing the way healthcare providers communicate options to patients, making complex information more accessible and understandable. By comparing the OASIS DA training with the current decision aid tool, researchers hope to discover which method better supports patients in making informed choices about their care. This could lead to more personalized and effective treatment decisions for liver cancer patients.

What evidence suggests that this trial's decision aid tools could be effective for improving liver cancer care?

Research has shown that tools like the OASIS DA, a training option in this trial, help doctors make better treatment choices for liver cancer. The OASIS DA tool uses advanced technology to match specific details with optimal treatment options, aiming to improve care quality. Studies have found that these tools reduce disagreements in treatment decisions, particularly for cancer. Other research supports that decision aids in apps assist cancer patients by simplifying information and easing decision-making. These tools are designed to facilitate collaboration between doctors and patients, leading to more effective and personalized care. ^{1 3 6 7 8}

Who Is on the Research Team?

Shari S. Rogal, MD MPH

Principal Investigator

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Are You a Good Fit for This Trial?

This trial is for veterans who've had recent medical care at a VA center and have liver cirrhosis or related complications, as well as healthcare providers involved in improving care at these centers. It's not for those who've had a liver transplant or currently have active liver cancer.

Inclusion Criteria

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

Exclusion Criteria

I am a veteran who has undergone a transplant.

I am a veteran with active liver cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Sites receive training on either the OASIS decision aid or the current decision aid tool

4 weeks

1 visit (in-person)

Intervention

Implementation of the decision aid tools at VA medical centers to improve HCC screening rates

6 months

Quarterly assessments

Follow-up

Participants are monitored for effectiveness and maintenance of the intervention

6 months

Quarterly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Current DA Tool training
• OASIS DA training

Trial Overview Project OASIS is testing a new decision aid tool against the current one to see which better identifies barriers and matches strategies to improve healthcare implementation. This study randomly assigns different VA centers to use either the new or current tool.

How Is the Trial Designed?

Group I: OASIS DA Experimental Treatment 1 Intervention

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

Group II: Current DA Tool Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

VA Ann Arbor Healthcare System

Collaborator

Trials

19

Recruited

10,300+

VA Pittsburgh Healthcare System

Collaborator

Trials

36

Recruited

15,900+

Citations

1. withpower.com withpower.com/trial/phase-carcinoma-hepatocellular-10-2023-38032

Implementation Strategy Training for Liver Cancer (OASIS Trial) This trial tests a new decision aid tool that uses machine learning to help healthcare providers choose the best strategies for implementing effective ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9822660/

An Open-Access, Interactive Decision-Support Tool to ... A free, open-access decision-support tool for liver lesions that incorporates current guideline recommendations in a user-friendly interface

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03926039

Sharing Decision-making Program for HCC Patients ... Aim: Explore the effectiveness of sharing decision-making program interventions in the early stage of HCC to reduce treatment decisions conflicts and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9152304/

Effects of a smartphone application named “Shared ... Evidence shows that decision aids are effective for cancer patients through mobile applications (apps), for example, the decision aid software ...

5. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/research/survivorship-cancer-outcomes-research-initiative/research-clinical-trials

Survivorship and Cancer Care Delivery Research and ... SCOR researchers investigate survivorship from all angles and conduct clinical trials in order to find the best possible treatments for patients.

6. store.decisionhealth.com store.decisionhealth.com/oasis-e-trainer-2nd-edition

OASIS-E Trainer, Second Edition DecisionHealth's OASIS-E Trainer, Second Edition provides the assessment and care planning strategies you'll need to achieve OASIS-E accuracy and quality ...

7. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-022-01883-w

Effects of a smartphone application named “Shared Decision ... The goal of this study is to explore the effects of a “Shared Decision Making Assistant” smartphone application on the decision-making of informed patients ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1743919122006197

Development and validation of safety and efficacy ... The proposed SEARCHER model demonstrated good performance to individually predict safety and efficacy of hepatectomy in elderly patients with HCC.