Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05693649
Collaborator
(none)
20,000
1
5
46
435.1

Study Details

Study Description

Brief Summary

This is a 3-year pragmatic, randomized clinical trial among average-risk patients at diverse primary care practices who are overdue for colorectal (CRC) screening. This project aims to evaluate the effect of a centralized program that includes direct outreach to patients and visit-based, clinician directed nudges facilitated by the electronic health record (EHR) with follow-up text messaging on the uptake of CRC screening. The primary outcome is CRC screening completion at 3 years. Patient and clinician factors impacting the experience and effectiveness of the intervention will be explored through surveys and qualitative interviews.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: No Direct Patient Outreach
  • Behavioral: Direct Patient Outreach: Colonoscopy Only
  • Behavioral: Direct Patient Outreach: Sequential Choice
  • Behavioral: Visit-Based Nudge/Text
  • Behavioral: No Nudge/Text
N/A

Detailed Description

Despite effective strategies for prevention, early detection, and treatment, colorectal cancer (CRC) remains the second leading cause of cancer death in the United States (US). While there have been considerable policy and system-level efforts to increase CRC screening rates, uptake remains well below national goals of 80% participation. Members of racial and ethnic minorities are even further behind. Approaches to increase population-based screening can consider [1] how screening is encouraged by targeting the clinicians who typically order or recommend the procedure or the patient who completes it; and [2] the kind of screening offered (e.g., colonoscopy or fecal immunochemical testing [FIT]). This project simultaneously tests interventions along both of these dimensions.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20000 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
May 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1A: Usual Care

Patients assigned to the Usual Care arm will receive current usual care and will not receive direct patient outreach or any visit-based interventions from this trial.

Behavioral: No Direct Patient Outreach
Patient will not receive direct outreach prompting them to schedule and/or complete colorectal cancer screening.

Behavioral: No Nudge/Text
Patient's clinician will not receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will not receive a text message 3 days after visit reminding them to complete colorectal cancer screening.

Experimental: Arm 2A: Colonoscopy Only and No Nudge/Text

Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. Patients randomized to this arm will not receive visit-based interventions.

Behavioral: Direct Patient Outreach: Colonoscopy Only
Patient will receive direct outreach including an order to schedule and complete colonoscopy.

Behavioral: No Nudge/Text
Patient's clinician will not receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will not receive a text message 3 days after visit reminding them to complete colorectal cancer screening.

Experimental: Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text

Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. Patients randomized to this arm who attend a visit with their Primary Care Physician (PCP) will additionally receive a visit-based, clinician directed nudge to discuss colorectal cancer screening and a follow-up text 3 days post-visit to encourage screening completion.

Behavioral: Direct Patient Outreach: Colonoscopy Only
Patient will receive direct outreach including an order to schedule and complete colonoscopy.

Behavioral: Visit-Based Nudge/Text
Patient's clinician will receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will also receive a text message 3 days after visit reminding them to complete colorectal cancer screening.

Experimental: Arm 3A: Sequential Choice and No Nudge/Text

Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. If not completed, patients will receive an order and a mailed fecal immunochemical test (FIT) with a reminder to complete CRC screening. Patients randomized to this arm will not receive visit-based interventions.

Behavioral: Direct Patient Outreach: Sequential Choice
Patient will receive direct outreach including an order to schedule and complete colonoscopy then an at-home fecal immunochemical test (FIT) if colonoscopy is not completed.

Behavioral: No Nudge/Text
Patient's clinician will not receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will not receive a text message 3 days after visit reminding them to complete colorectal cancer screening.

Experimental: Arm 3B: Sequential Choice and Visit-Based Nudge/Text

Using bulk ordering, patients assigned to this arm will receive an order for colonoscopy and direct outreach (via text message and either the electronic patient portal or mailed letter, depending on their patient portal status) informing them they are overdue for CRC screening. If not completed, patients will receive an order and a mailed fecal immunochemical test (FIT) with a reminder to complete CRC screening. Patients randomized to this arm who attend a visit with their Primary Care Physician (PCP) will additionally receive a visit-based, clinician directed nudge to discuss colorectal cancer screening and a follow-up text 3 days post-visit to encourage screening completion.

Behavioral: Direct Patient Outreach: Sequential Choice
Patient will receive direct outreach including an order to schedule and complete colonoscopy then an at-home fecal immunochemical test (FIT) if colonoscopy is not completed.

Behavioral: Visit-Based Nudge/Text
Patient's clinician will receive an alert prompting them to discuss colorectal cancer screening with their patient upon visit. Patient will also receive a text message 3 days after visit reminding them to complete colorectal cancer screening.

Outcome Measures

Primary Outcome Measures

  1. CRC screening completion at 3 years [3 years]

    CRC screening completion at 3 years, which could be satisfied by any one of the following: colonoscopy completion at any time, negative FIT completed 2 times, or positive FIT followed by diagnostic colonoscopy within 1 year.

Secondary Outcome Measures

  1. CRC screening rate [3 years]

    CRC screening completion at 3 years by any modality

  2. Choice of test [3 years]

    The proportion of patients who complete CRC screening by screening type

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 72 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients ages 50-72

  • Followed by Primary Care with a participating Penn Medicine PCP listed and at least one visit in the last 2 years

  • Not up to date on colorectal cancer screening per Health Maintenance (no colonoscopy in the last 10 years, stool testing in the last year, flexible sigmoidoscopy in the last 5 years, MT-sDNA in the last 3 years).

Exclusion Criteria:
  • Personal or significant family history of CRC, colonic polyps, hereditary nonpolyposis colorectal cancer syndrome, familial adenomatous polyposis syndrome, other gastrointestinal cancer, gastrointestinal bleeding, iron-deficiency anemia, or inflammatory bowel disease

  • History of total colectomy, dementia or metastatic cancer

  • Currently on hospice or receiving palliative care

  • Uninsured or self-pay patients

  • Currently scheduled for a colonoscopy or sigmoidoscopy

  • Active order for multitarget stool DNA testing (MT-sDNA)

  • History of paraplegia or quadriplegia

  • Elevated chance of mortality within 3 years according to mortality risk algorithm

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn Medicine Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Shivan Mehta, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shivan Mehta, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05693649
Other Study ID Numbers:
  • UPCC 14022
First Posted:
Jan 23, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shivan Mehta, Principal Investigator, Abramson Cancer Center of the University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023