Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Diseases

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Individuals randomized to Group 1 will receive usual medical care and will not be directly contacted at any point of the trial. Study data and outcomes will be abstracted from the EMR.

Individuals randomized to Group 2 will receive mailed outreach invitation.

Individuals randomized to Group 3 will receive mailed outreach invitation and patient navigation.

Individuals randomized to Group 2 will receive:

1. Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test.
2. "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion. Up to three attempts will be made. All communications will use standard English or Spanish scripts.
3. Centralized process to promote guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic.

Mailed Outreach Invitation

Individuals randomized to Group 3 will receive:

1. Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test.
2. "Live" phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion "and address patients' self-reported barriers to HCC screening (e.g., it does not apply to me). Up to three attempts will be made. All communications will use standard English or Spanish scripts.
3. Centralized navigation to promote screening completion (i.e., appointment reminder phone calls from patient navigator) and guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic.

Mailed Outreach Invitation and Patient Navigation

Amit Singal, MD

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.

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

RCT of Strategies to Improve Screening Rates Among a Cohort of Cirrhotic Patients at High Risk for Developing HCC in a Safety-net Health System

Defined as the proportion of patients completing HCC screening within 6 months of randomization.

Defined as the proportion of patients completing HCC screening every 6 months within 18 months of randomization.

Defined as the proportion of patients completing HCC screening every 7 months within 21 months of randomization.

Defined as proportion of patients with HCC and the proportion of patients with early HCC.

Defined as proportion of patients completing any HCC screening.

Simple total program costs will be calculated for the intervention arms (Groups 2 and 3) and compared with a one-way ANOVA model.

Defined as the proportion of time up-to date with HCC screening.

Defined as the proportion of patients with a suspicious lesion (as any solid-appearing mass ≥1 cm in diameter not characterized as benign).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System	NCT02312817	Carcinoma, Hepa... Liver Neoplasms	Mailed Outreach... Mailed Outreach...	21 Years -	University of Texas Southwestern Medical Center
RCT of Screening Strategies Among Patients at High Risk for Developing HCC in a Safety-net Health System	NCT02312817	Carcinoma, Hepa... Liver Neoplasms	Mailed Outreach... Mailed Outreach...	21 Years -	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for mailed outreach invitation and patient navigation