Clinical trial NCT06710509: Patient Reminders Optimizing Mail-in Prevention Testing for Colorectal Cancer
Official title: Patient Reminders Optimizing Mail-in Prevention Testing for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colon Cancer Screening
Keywords: colon cancer screening
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
First posted: 2024-11-29
Enrollment: 2400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage kit return at 4 weeks
timeFrame: 4 weeks from date first message was sent
Secondary outcomes:
measure: Percentage kit return at 8 weeks
timeFrame: 8 weeks from date first message was sent
measure: Percentage kit return at 12 weeks
timeFrame: 12 weeks from date first message was sent
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Ascension Health
state: Missouri
Study officials:
affiliation: Ascension Health
name: Emily Rosenzweig
role: PRINCIPAL_INVESTIGATOR
References: