NCT04746469

Brief Summary

As a part of UCLA Health's continued goal of improving patient care the investigators are updating our mailing campaign for our FIT Kit colorectal cancer screening that the investigators administer 2 times per year to include an automated phone call reminder to patients who are overdue for average-risk colorectal cancer screening and enrolled in a mailed FIT program. This will help the investigators evaluate if automated phone calls are effective at improving compliance with CRC screening, in addition to mailed FIT and embedded electronic health record (EHR) portal messages to patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 2, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.9 years

First QC Date

January 24, 2021

Last Update Submit

September 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall colorectal cancer screening uptake (any modality)

    Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.

    6 months

Secondary Outcomes (1)

  • Colorectal cancer screening uptake by modality

    6 months

Study Arms (2)

Control

NO INTERVENTION

This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)

Intervention

EXPERIMENTAL

This group will receive standard FIT mailer protocol (as above) PLUS delayed automated phone reminder

Behavioral: Delayed automated phone call

Interventions

Cipher provides automated phone calls to patients; in this case the script for Cipher was modified to provide patients a reminder to return FIT kits, allow patients to request a new kit in case they need a replacement, and to allow patients to provide information if they already completed CRC screening

Also known as: Cipher phone reminder
Intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overdue for average-risk colorectal cancer screening
  • Active primary care provider at UCLA seen within last 3 years

You may not qualify if:

  • Inactive mychart status at time of enrollment
  • Died within follow-up period
  • Received FIT kit in prior 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Health Department of Medicine, Quality Office

Los Angeles, California, 90095, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: \~2500 patients who are overdue for average-risk CRC screening and are enrolled in UCLA Health biannual mailed FIT program will be randomized to either control (mailed FIT kit + standard messaging) or intervention (mailed FIT Kit + standard messaging + delayed automated phone reminder)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2021

First Posted

February 9, 2021

Study Start

September 2, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations