CompletedNot Applicable

RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System

United States1,800 participantsStarted 2014-12

Plain-language summary

Hepatocellular carcinoma (HCC) is the 9th leading cause of cancer-related death in the US and one of the leading causes of death in patients with cirrhosis. Fewer than 1 in 5 high-risk patients undergo HCC screening, with lower rates in non-Caucasian and low socioeconomic status patients receiving care through safety-net health systems. Screening and follow-up failures lead to more advanced cancers, when curative therapies are not available and survival is significantly worse. Over 60% of HCC are diagnosed at advanced stages, due to poor recognition of high-risk patients, underuse of screening among these patients, and poor follow-up of abnormal screening tests. To address these barriers, the investigators propose to conduct a comparative effectiveness research randomized controlled trial of three screening strategies among a socioeconomically disadvantaged and racially diverse cohort of cirrhotic patients at high risk for developing HCC. Overall, 1800 patients attending Parkland, the Dallas safety-net health system, will be randomized to: * Group 1: Usual care, with visit-based HCC screening per discretion of individual providers * Group 2: Mailed HCC screening invitation outreach to eligible patients (low resource intensity) * Group 3: Mailed HCC screening invitation outreach to eligible patients combined with centralized patient navigation to promote screening completion and follow-up (high resource intensity) Through three specific aims, this effectiveness research randomized controlled trial will: * Aim 1: Engage stakeholders in design and implementation of HCC screening outreach interventions. * Aim 2: Compare the clinical effectiveness and patient acceptability of the intervention strategies to increase completion of one-time and repeat HCC screening. * Aim 3: Evaluate whether intervention effects are moderated by patient sex, race, ethnicity, English proficiency, and connectedness to primary care. The screening intervention strategies combine EMR-enabled case identification, system-level screening outreach, and patient navigation to improve identification of previously unrecognized cirrhotic patients, promote HCC screening completion, and facilitate follow-up of abnormal screening tests. This study will engage stakeholders throughout the research process, evaluate the effectiveness and acceptability of HCC screening strategies, and determine which patient subgroups benefit the most.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

As the risk of HCC is significant in those with cirrhosis regardless of age, gender, or race, we will include adult patients with cirrhosis of all ages (\> 21 years old), both sexes, and all races/ethnicities who speak English or Spanish. Our study leverages Parkland's electronic medical record (EMR) and uses a novel EMR-enabled case-finding algorithm to identify patients with known cirrhosis, using ICD-9 codes, as well as those with unrecognized but suspected cirrhosis, using a set of laboratory data. Patients with ICD-9 codes for cirrhosis or cirrhosis complication will be eligible for study enrollment if they meet the following criteria: * One or more encounter with ICD-9 codes 456.0, 456.1, 456.2, 456.21, 567.23, 572.2, 572.3, and 572.4; OR, * Two or more encounters with ICD-9 codes 571.2 and/or 571.5; OR, * One encounter with ICD-9 codes 571.2 or 571.5 from a Parkland primary care clinic, GI, or women's health center. Patients with an AST to platelet ratio index (APRI) \> 1.5 in combination with a platelet count \< 300, and aspartate aminotransferase (AST) \< 1,000 during study enrollment will be eligible. We will exclude patients who have known HCC or a suspicious appearing mass on imaging within six months prior to ascertainment of eligibility, as these patients require further diagnostic testing instead of routine screening. We will exclude patients with Child Pugh class C cirrhosis or other significant comorbid conditions with a life expectancy less than one yea…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

One-time Screening

Timeframe: Outcomes will be adjudicated 6 months after randomization.

Repeat Screening (Every 6 Months)

Timeframe: Outcomes will be adjudicated 18 months after randomization.

Trial details

NCT IDNCT02312817

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

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