Viewing Study NCT04831827



Ignite Creation Date: 2024-05-06 @ 4:00 PM
Last Modification Date: 2024-10-26 @ 2:01 PM
Study NCT ID: NCT04831827
Status: WITHDRAWN
Last Update Posted: 2021-10-27
First Post: 2021-04-01

Brief Title: Promoting Equity for Cancer Screening and Follow-up
Sponsor: Mayo Clinic
Organization: Mayo Clinic

Study Overview

Official Title: Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up PREMiS
Status: WITHDRAWN
Status Verified Date: 2021-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Insufficient study resources and change in practice
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a randomized trial to assess the efficacy of reminder mechanisms on colorectal cancer CRC screening uptake among a cohort of patients who were previously mailed a multitarget stool DNA mt-sDNA test and did not complete the screening Patients will be identified as being due for CRC screening and will be mailed a mt-sDNA kit to their home Patients who do not complete screening with mt-sDNA within 30 days will be identified and randomized into one of three study arms to receive reminders to complete the mt-sDNA screening The primary outcome is the rate of completion of screening for colorectal cancer with mt-sDNA test
Detailed Description: Colorectal cancer CRC is the third leading cause of cancer-related death in the United States and screening has been shown to reduce mortality from CRC Screening is underutilized in the United States particularly in some communities such as BlacksAfrican Americans American IndiansAlaskan Natives and rural populations contributing to disparities in mortality

For CRC screening mt-sDNA testing is one of several tests that are recommended by the United States Preventive Services Task Force USPSTF As part of a quality improvement program at our institution those who are due for CRC screening are identified using a validated electronic algorithm and a kit is mailed directly to each patient Our intervention is initiated on non-respondents to the mailed mt-sDNA outreach by testing the use of a technology-enabled reminder system

Thirty days after being mailed a mt-sDNA kit patients who have not completed the screening will be randomized to receive a reminder to complete the mt-sDNA screening by one of three mechanisms time 0

1 Automated reminder using the EHR patient portal messaging system
2 Automated reminder using a customized interactive voice response IVR system
3 Personalized reminder phone calls from the clinical team

This will allow for an empirical test of processes that can be employed to improve delivery of CRC screening and reduce preventable deaths in populations that are underserved with evidence-based interventions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None