Patient Reminders Optimizing Mail-in Prevention Testing for Colorectal Cancer (PROMPT-CRC)
Screening is an important tool for early colorectal cancer detection, and the most recent evidence suggests that early detection significantly improves survival rates. Current medical guidelines recommend that all people aged 45 to 75 be screened regularly. However, actual rates of screening in the United States are much lower than this.
Colonoscopy is the gold standard in colon cancer screening, serving as both screening and prevention. However there are many barriers to colonoscopy uptake, including lack of awareness, patient reticence, scheduling complexity, and market variation in access. Stool testing is a valuable alternative to colonoscopy for low-risk patients. Exact Sciences is the company that makes Cologuard, which is the current best-in-class stool testing for colon cancer screening.
Despite being a convenient at-home screening option, patient engagement with screening via stool testing has room for improvement. Over 40% of Ascension patients who have a stool testing order placed for them never return the screening kit in the mail.
A large body of research demonstrates that interventions informed by behavioral science can support patients in engaging in a variety of preventative health behaviors. Personalized nudges have proven to be among the most effective types of interventions, along with interventions aimed at helping patients overcome barriers to screening. We aim to test whether behavioral nudges can increase stool testing kit return rates.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Screening is an important tool for early colorectal cancer detection, and the most recent evidence suggests that early detection significantly improves survival rates. Current medical guidelines recommend that all people aged 45 to 75 be screened regularly. However, actual rates of screening in the United States are much lower than this, particularly among younger patient cohorts. Screening rates are still lower for patients who are "socially vulnerable" - a measure of the degree to which social and demographic factors make them vulnerable to health disparities.
Colonoscopy is the gold standard in colon cancer screening, serving as both screening and prevention. However there are many barriers to colonoscopy uptake, including lack of awareness, patient reticence, scheduling complexity, and market variation in access. Stool testing is a valuable alternative to colonoscopy for low-risk patients. Exact Sciences is the company that makes Cologuard, which is the current best-in-class stool testing for colon cancer screening.
Despite being a convenient at-home screening option, patient engagement with screening via stool testing has room for improvement. Over 40% of Ascension patients who have a stool testing order placed for them never return the screening kit in the mail.
A large body of research demonstrates that interventions informed by behavioral science can support patients in engaging in a variety of preventative health behaviors. Personalized nudges have proven to be among the most effective types of interventions, along with interventions aimed at helping patients overcome barriers to screening.4 We aim to test whether behavioral nudges can increase stool testing kit return rates.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
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St Louis, Missouri, United States, 63134
- Ascension Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 45-75
- Have either a mobile phone number or an email address on file with the health system
- Included in and non-compliant on the Ascension Colon Cancer Screening Clinical Priority Goal measure.
- Have consented to receive electronic communications from the health system
- Ascension primary care provider placed an order for stool testing between 60 and 180 days prior to the intervention.
- No record of Cologuard stool testing lab results returned within 60 days of the order being placed.
Exclusion Criteria:
- Patients whose primary care providers are exempted from the campaign by the health system
- Patients with a record of having been screened for colorectal cancer through some other method during the time since the initial order for Cologuard stool testing was placed.
- Have received a nudge campaign from the Clinical Transformation team in the past 90 days
- Patients who have previously opted out of receiving electronic communications from the health system in our message delivery platform (Salesforce)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Group receiving the messages
|
Patients in the Experimental Condition will receive a set of up to three email and text messages over the course of five days, while also receiving usual care which could include messaging from their practice or the electronic health record.
|
|
No Intervention: Control Group
Group not receiving the messages
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage kit return at 4 weeks
Time Frame: 4 weeks from date first message was sent
|
Percentage of patients who have Cologuard stool testing lab results returned 4 weeks after receiving the intervention
|
4 weeks from date first message was sent
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage kit return at 8 weeks
Time Frame: 8 weeks from date first message was sent
|
Percentage of patients who have Cologuard stool testing lab results returned 8 weeks after receiving the intervention
|
8 weeks from date first message was sent
|
|
Percentage kit return at 12 weeks
Time Frame: 12 weeks from date first message was sent
|
Percentage of patients who have Cologuard stool testing lab results returned 12 weeks after receiving the intervention
|
12 weeks from date first message was sent
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura Feemster, MD MS, Ascension Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAS20240016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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