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

Not Applicable

Completed

• Conditions: Carcinoma, Hepatocellular; Liver Neoplasms
• Interventions: Other: Mailed Outreach Invitation and Patient Navigation; Other: Mailed Outreach Invitation

• Registration Number: NCT02312817
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-06-18
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-09
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

• Parkland patients ≥ 21 years of age
• Diagnosis of cirrhosis or meets criteria for suspected cirrhosis
• ≥ 1 outpatient visit during 12 months prior to randomization
• Contact information on file
• English or Spanish speaking

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Exclusion Criteria

• HCC or suspicious mass on imaging
• Any malignancy except malignant neoplasm of skin
• Metastatic solid tumor
• Palliative care referral
• Liver transplant
• Child Pugh C

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	Mailed Outreach Invitation and Patient Navigation	Individuals randomized to Group 3 will receive mailed outreach invitation and patient navigation.
Group 2	Mailed Outreach Invitation	Individuals randomized to Group 2 will receive mailed outreach invitation.

Primary Outcome Measures

Name	Time	Method
One-time Screening	Outcomes will be adjudicated 6 months after randomization.	Defined as the proportion of patients completing HCC screening within 6 months of randomization.
Repeat Screening (Every 6 Months)	Outcomes will be adjudicated 18 months after randomization.	Defined as the proportion of patients completing HCC screening every 6 months within 18 months of randomization.

Secondary Outcome Measures

Name	Time	Method
Repeat Screening (Every 7 Months)	Outcomes will be adjudicated 21 months after randomization.	Defined as the proportion of patients completing HCC screening every 7 months within 21 months of randomization.
HCC and Early HCC	Outcomes will be adjudicated 18 and 21 months after randomization.	Defined as proportion of patients with HCC and the proportion of patients with early HCC.
Any HCC Screening	Outcomes will be adjudicated 18 and 21 months after randomization.	Defined as proportion of patients completing any HCC screening.
Predictors of HCC Screening Completion	Outcomes will be adjudicated 18 and 21 months after randomization.
Intervention Cost	Outcomes will be adjudicated 18 and 21 months after randomization.	Simple total program costs will be calculated for the intervention arms (Groups 2 and 3) and compared with a one-way ANOVA model.
Proportion of Time Covered	Outcomes will be adjudicated 18 and 21 months after randomization.	Defined as the proportion of time up-to date with HCC screening.
Suspicious Lesion	Outcomes will be adjudicated 18 and 21 months after randomization.	Defined as the proportion of patients with a suspicious lesion (as any solid-appearing mass ≥1 cm in diameter not characterized as benign).

Trial Locations

Locations (1)

Parkland Health & Hospital System; 🇺🇸 Dallas, Texas, United States