Promoting Equity for Cancer Screening and Follow-up

Promoting Equity Through Multicomponent Strategies for Cancer Screening and Follow-up (PREMiS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal (Colon or Rectal) Cancer
• Intervention / Treatment: Other: IVR Reminder; Other: Phone call from research team; Other: EHR Portal message

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 Blacks/African Americans, American Indians/Alaskan 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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults, between 50 to 75 years old.
• Due for colorectal cancer screening based on not having a record of a colonoscopy within 10 years, sigmoidoscopy, or CT colonography within 5 years, mt-sDNA within 3 years, or FIT within 1 year.
• Asymptomatic for colorectal cancer such as rectal bleeding or reported abdominal mass.

Exclusion Criteria:

• For the intervention study, patients will be restricted to those aged 50 to 75 years and are due for colorectal cancer screening.
• We will exclude any patient who has:
• Had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, mt-sDNA within 3 years, CT colonography within 5 years, and FOBT/FIT within twelve months of inclusion into the study;
• A diagnosis of CRC or other GI cancer;
• History of confirmed Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis) or other colitis;
• Had a colectomy, partial or total;
• A diagnosis of Lynch Syndrome;
• A diagnosis of Familial Adenomatous Polyposis (FAP);
• Iron deficiency anemia;
• Lower GI bleeding;
• A metastatic (Stage IV) blood or solid tumor cancer;
• End stage renal disease;
• A first degree relative with CRC prior to age 50 or 2+ first degree relatives diagnosed at any age.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IVR Reminder; Participants will receive an interactive voice reminder	Other: IVR Reminder; Participants will receive an interactive voice reminder (IVR) to complete mt-sDNA screening at day 7 and 21.
Active Comparator: Personalized Phone Call Reminder; Participants will receive a personalized phone call	Other: Phone call from research team; Patients will receive a scripted phone call from the research team to remind them to complete the mt-sDNA screening at day 7 and 21.
Active Comparator: Portal Message Only; Participants will receive a online patient portal message reminder	Other: EHR Portal message; Patients will receive an EHR patient portal message with a scripted message to remind them to complete the mt-sDNA screening at day 7 and 21.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint (intention-to-treat)	The completion rate of mt-sDNA among eligible patients. The primary comparison will be the return rate compared across intervention arms.	Completion by 6 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome (per protocol analysis)	The completion rate of mt-sDNA among eligible patients. The comparison will be the return rate compared across intervention arms, excluding participants who received an alternative intervention due to not having appropriate portal access.	Completion by 6 months post randomization

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Chyke Doubeni, MBBS, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 20-012010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No