NCT04248816

Brief Summary

This is a 3-arm pilot randomized controlled trial applying behavioral economic approaches (opt-out framing and financial incentives) to encourage patients with liver cirrhosis to complete regular surveillance ultrasounds which may allow for earlier diagnosis of and better outcomes for hepatocellular carcinoma (HCC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
615

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

November 19, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 14, 2023

Completed
Last Updated

February 14, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 27, 2020

Results QC Date

November 22, 2022

Last Update Submit

January 19, 2023

Conditions

Hepatocellular CarcinomaCirrhosis

Keywords

Behavioral EconomicsScreeningOutreach

Outcome Measures

Primary Outcomes (1)

  • HCC Screening Completion

    The percentage of subjects who have a surveillance abdominal ultrasound.

    6 months

Secondary Outcomes (1)

  • HCC Screening Method

    6 months

Study Arms (3)

Usual Care

EXPERIMENTAL

Standard of care

Behavioral: Usual care

Opt-out

EXPERIMENTAL

Facilitated outreach and opt-out framing

Behavioral: Opt-out

Opt-out + Incentive

EXPERIMENTAL

Facilitated outreach and opt-out framing plus a financial incentive

Behavioral: Opt-out + Incentive

Interventions

Usual careBEHAVIORAL

Subjects will receive outreach through their providers as is standard of care.

Usual Care
Opt-outBEHAVIORAL

Research staff will send a letter to patients encouraging them to get a surveillance ultrasound and include an order slip for them to get it done at a health system facility.

Opt-out
Opt-out + IncentiveBEHAVIORAL

Research staff will send a letter to patients encouraging them to get a surveillance ultrasound and include an order slip plus an unconditional $20 incentive for them to get it done at a health system facility.

Opt-out + Incentive

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are 18+ years old
  • Current diagnosis of cirrhosis or advanced fibrosis
  • or more visits to a Penn Gastroenterology/Hepatology practice in the preceding two years
  • Currently followed by Penn Gastroenterology/Hepatology
  • Must live in the Philadelphia Metropolitan Statistical Area

You may not qualify if:

  • History of HCC or other liver carcinoma diagnosis
  • History of liver transplant
  • Completed HCC screening within the past 7 months
  • Have a future screening scheduled
  • Have a different screening modality recommended by their physician (MRI, CT, etc.)
  • Patients with metastatic cancer
  • Patients receiving hospice care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularFibrosis

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Shivan Mehta
Organization
University of Pennsylvania
shivan.mehta@pennmedicine.upenn.edu
215-898-6027

Study Officials

  • Shivan Mehta, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 30, 2020

Study Start

November 19, 2020

Primary Completion

November 26, 2021

Study Completion

February 14, 2022

Last Updated

February 14, 2023

Results First Posted

February 14, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)