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

Primary Purpose

Colorectal Cancer, Colorectal Neoplasms, Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyChart Priming Message
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal Cancer Screening, Colon Cancer, Nudge, Behavior and Behavior Mechanisms, Behavioral Economics, Health Screening

Eligibility Criteria

51 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Health Department of Medicine, Quality Office

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

MyChart Message

Arm Description

This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)

This group will receive a message via EHR portal informing them about the incoming FIT Kit

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to screening
Time (months) to screening uptake
Colorectal cancer screening uptake by modality
Rate of completion of CRC screening by modality type
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.

Full Information

First Posted
October 28, 2021
Last Updated
November 8, 2021
Sponsor
University of California, Los Angeles
Collaborators
UCLA Vatche and Tamar Manoukian Division of Digestive Diseases, UCLA Department of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05115916
Brief Title
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates
Official Title
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates: A Randomized Quality Improvement Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 28, 2019 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
UCLA Vatche and Tamar Manoukian Division of Digestive Diseases, UCLA Department of Medicine

4. Oversight

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

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Neoplasms, Colorectal Cancer Screening
Keywords
Colorectal Cancer Screening, Colon Cancer, Nudge, Behavior and Behavior Mechanisms, Behavioral Economics, Health Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3880 patients 51-75 years old, within the UCLA Health Managed Care group overdue for average risk CRC screening without prior history of documented FIT or colonoscopy will be randomized into 2 groups, in a 1:1 ratio. The 2 groups represent standard of care, and then the MyChart Message group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3880 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)
Arm Title
MyChart Message
Arm Type
Experimental
Arm Description
This group will receive a message via EHR portal informing them about the incoming FIT Kit
Intervention Type
Behavioral
Intervention Name(s)
MyChart Priming Message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Colorectal Cancer Screening Uptake
Description
Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to screening
Description
Time (months) to screening uptake
Time Frame
6 months
Title
Colorectal cancer screening uptake by modality
Description
Rate of completion of CRC screening by modality type
Time Frame
6 months
Title
Effect of electronic primer message on CRC uptake among participants who opened
Description
Rate of completion of CRC screening among individuals who received the MyChart electronic primer.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
UCLA Health Department of Medicine, Quality Office
City
Westwood
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD for this investigation.
Citations:
PubMed Identifier
35119462
Citation
Goshgarian G, Sorourdi C, May FP, Vangala S, Meshkat S, Roh L, Han MA, Croymans DM. Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Test Kit on Colorectal Cancer Screening Rates: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2146863. doi: 10.1001/jamanetworkopen.2021.46863.
Results Reference
derived

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

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