Trial Outcomes & Findings for Hepatocellular Carcinoma Surveillance in Cirrhotics (NCT NCT04248816)

NCT ID: NCT04248816

Last Updated: 2023-02-14

Results Overview

The percentage of subjects who have a surveillance abdominal ultrasound.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 615 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2023-02-14

Participant Flow

Participant milestones

Measure	Usual Care Standard of care Usual care: Subjects will receive outreach through their providers as is standard of care.	Opt-out Facilitated outreach and opt-out framing Opt-out: 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 + Incentive Facilitated outreach and opt-out framing plus a financial incentive Opt-out + Incentive: 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.
Overall Study STARTED	123	245	247
Overall Study COMPLETED	116	224	222
Overall Study NOT COMPLETED	7	21	25

Reasons for withdrawal

Measure	Usual Care Standard of care Usual care: Subjects will receive outreach through their providers as is standard of care.	Opt-out Facilitated outreach and opt-out framing Opt-out: 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 + Incentive Facilitated outreach and opt-out framing plus a financial incentive Opt-out + Incentive: 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.
Overall Study Ineligible post-randomization	7	21	25

Baseline Characteristics

Hepatocellular Carcinoma Surveillance in Cirrhotics

Baseline characteristics by cohort

Measure	Usual Care n=116 Participants Standard of care Usual care: Subjects will receive outreach through their providers as is standard of care.	Opt-out n=224 Participants Facilitated outreach and opt-out framing Opt-out: 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 + Incentive n=222 Participants Facilitated outreach and opt-out framing plus a financial incentive Opt-out + Incentive: 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.	Total n=562 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 11.6 • n=5 Participants	61.4 years STANDARD_DEVIATION 10.9 • n=7 Participants	62.9 years STANDARD_DEVIATION 11.0 • n=5 Participants	62.1 years STANDARD_DEVIATION 11.1 • n=4 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	101 Participants n=7 Participants	92 Participants n=5 Participants	243 Participants n=4 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	123 Participants n=7 Participants	130 Participants n=5 Participants	319 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	26 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	106 Participants n=5 Participants	213 Participants n=7 Participants	207 Participants n=5 Participants	526 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants	88 Participants n=7 Participants	94 Participants n=5 Participants	228 Participants n=4 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	116 Participants n=7 Participants	104 Participants n=5 Participants	286 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

The percentage of subjects who have a surveillance abdominal ultrasound.

Outcome measures

Measure	Usual Care n=116 Participants Standard of care Usual care: Subjects will receive outreach through their providers as is standard of care.	Opt-out n=224 Participants Facilitated outreach and opt-out framing Opt-out: 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 + Incentive n=222 Participants Facilitated outreach and opt-out framing plus a financial incentive Opt-out + Incentive: 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.
HCC Screening Completion	27.6 Percentage of participants Interval 19.5 to 35.7	54.5 Percentage of participants Interval 47.9 to 61.0	54.1 Percentage of participants Interval 47.5 to 60.6

SECONDARY outcome

Timeframe: 6 months

The percentage of subjects who have any hepatocellular carcinoma surveillance.

Outcome measures

Measure	Usual Care n=116 Participants Standard of care Usual care: Subjects will receive outreach through their providers as is standard of care.	Opt-out n=224 Participants Facilitated outreach and opt-out framing Opt-out: 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 + Incentive n=222 Participants Facilitated outreach and opt-out framing plus a financial incentive Opt-out + Incentive: 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.
HCC Screening Method	32.8 Percentage of patients Interval 24.2 to 41.3	59.4 Percentage of patients Interval 52.9 to 65.8	57.2 Percentage of patients Interval 50.7 to 63.7

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Opt-out

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Opt-out + Incentive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 12 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Shivan Mehta

University of Pennsylvania

Phone: 215-898-6027

Email: shivan.mehta@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place