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Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

Primary Purpose

Colorectal Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No Direct Patient Outreach
Direct Patient Outreach: Colonoscopy Only
Direct Patient Outreach: Sequential Choice
Visit-Based Nudge/Text
No Nudge/Text
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring Prevention, Cancer Screening, Behavioral Economics

Eligibility Criteria

50 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Active order for Fecal Immunochemical Test (FIT) in the last 60 days

Sites / Locations

  • Penn Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1A: Usual Care

Arm 2A: Colonoscopy Only and No Nudge/Text

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

Arm 3A: Sequential Choice and No Nudge/Text

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

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

CRC screening completion at 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

CRC screening rate
CRC screening completion at 3 years by any modality
Choice of test
The proportion of patients who complete CRC screening by screening type

Full Information

First Posted
January 12, 2023
Last Updated
September 22, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05693649
Brief Title
Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening
Official Title
Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
December 21, 2026 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Prevention, Cancer Screening, Behavioral Economics

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1A: Usual Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2A: Colonoscopy Only and No Nudge/Text
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2B: Colonoscopy Only and Visit-Based Nudge/Text
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 3A: Sequential Choice and No Nudge/Text
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 3B: Sequential Choice and Visit-Based Nudge/Text
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No Direct Patient Outreach
Intervention Description
Patient will not receive direct outreach prompting them to schedule and/or complete colorectal cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Direct Patient Outreach: Colonoscopy Only
Intervention Description
Patient will receive direct outreach including an order to schedule and complete colonoscopy.
Intervention Type
Behavioral
Intervention Name(s)
Direct Patient Outreach: Sequential Choice
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Visit-Based Nudge/Text
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No Nudge/Text
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRC screening completion at 3 years
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
CRC screening rate
Description
CRC screening completion at 3 years by any modality
Time Frame
3 years
Title
Choice of test
Description
The proportion of patients who complete CRC screening by screening type
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Active order for Fecal Immunochemical Test (FIT) in the last 60 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Behavioral Economic Approaches for Population-Based Colorectal Cancer Screening

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