Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates

Colorectal Cancer Clinical Trial

Official title:

Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates: A Randomized Quality Improvement Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115916
• Other study ID #: FITPrimer
• Status: Completed
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: November 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Behavioral economics principles have increasingly been shown to improve health outcomes in the United States. They offer the ability to implement simple, low-cost and effective interventions to address key health issues without sacrificing the autonomy of patients. Colorectal cancer (CRC) screening is a key area where behavioral economics principles can help improve health outcomes. Despite being the second leading cause of cancer related death, the rate of CRC screening remains well below national targets. Interventions to address these issues, and improve screening rates at our institution have including implementing a Mailed FIT outreach program, and adding an informational letter that utilizes behavioral economic principles. To further improve our screening rates, this project builds upon our previous efforts to include a randomized electronic message primer via patients electronic patient portal, to help alert them of incoming FIT Kit and complete screening. This study will contribute to the growing literature of behavioral economics in medicine, while addressing an important health issue.

Description:

Colorectal cancer (CRC) is the second leading cause of death from cancers affecting both men and women in the United States. One in 17 Americans will suffer from CRC during his/her lifetime. Early detection by screening has been shown to reduce CRC mortality. Despite screening recommendations, the U.S. screening rate remains well below the national benchmark of 80% as established by the National Colorectal Cancer Roundtable. The U.S. Multi-Society Task Force (MSTF), however, does recommended FIT and colonoscopy as first line screening modalities for CRC in 2017. To help address the issue of suboptimal CRC screening, the investigators implemented an intervention utilizing the principles of behavioral economics to improve screening rates. Studies in behavioral economics and psychology indicate that how information or choice is framed impacts behavior in predictable ways, which has applications in health and medicine, including the design of CRC screening strategies. This project builds upon our institutions continued quality improvement efforts utilizing behavioral economics principles to improve CRC screening, through improving the choice architecture, framing and salience of information to incentivize routine screening.

For this project the investigators will leverage our electronic health records (EHR) patient portals to improve CRC screening. Specifically, the investigators developed an electronic primer within the EHR patient portal to alert patients due for CRC screening before arrival of a mailed FIT Kit. The investigators randomized implementation of the primer at the patient-level to determine whether the electronic primer improved CRC screening completion in patients enrolled in our mailed FIT program.

For our analysis, after summarizing our demographic data, the investigators plan to compare screening completion in the two study arms using an intention-to-treat analysis and t-tests. The investigators then plan a logistic regression and Cox proportional hazards model to compare time to screening utilization in the two study arms, controlling for age, sex, race, and ethnicity. Following this the investigators use Fisher's exact tests to compare completion of individual screening modalities in the two study arms. Lastly, the investigators plan a secondary, analysis to determine the impact of opening the portal message on screening utilization, using randomization arm as an instrumental variable. In this analysis the investigators compare the subset of patients in the intervention group that opened the portal primer message to the control group. P-values less than 0.05 are considered statistically significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3880
• Est. completion date: December 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 51 Years to 75 Years

Eligibility

Inclusion Criteria:

• Managed care patient, 51-75 years old

• Active primary care provider at UCLA seen within last 3 years

Exclusion Criteria:

• Inactive MyChart status or mailing address at time of enrollment

• Died within follow up period

• Any high-risk features including first degree family members with CRC, personal history of adenomas, history of inflammatory bowel disease, and any genetic GI cancer syndromes.

• Exclusion from March 2020 cohort if received FIT mailer within past 6 months

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Behavioral:
• MyChart Priming Message
In addition to the standard FIT mailer protocol, we will send randomized participants a message via their personal health portal. Patients receive the primer approximately 1-2 weeks prior to arrival of the FIT kit, which informed patients about the incoming FIT Kit and instructed patients to complete and return the kit promptly.

Locations

Country	Name	City	State
United States	UCLA Health Department of Medicine, Quality Office	Westwood	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Los Angeles	UCLA David Geffen School of Medicine, UCLA Department of Medicine, UCLA Vatche and Tamar Manoukian Division of Digestive Diseases

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Colorectal Cancer Screening Uptake	Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.	6 months
Secondary	Time to screening	Time (months) to screening uptake	6 months
Secondary	Colorectal cancer screening uptake by modality	Rate of completion of CRC screening by modality type	6 months
Secondary	Effect of electronic primer message on CRC uptake among participants who opened	Rate of completion of CRC screening among individuals who received the MyChart electronic primer.	6 months