Colorectal CancerNCT05115916
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates
A study testing MyChart Priming Message in people with Colorectal Cancer and Colorectal Neoplasms, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 51 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Cancer Screening
- What is being tested?
- MyChart Priming Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,880 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2019to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Managed care patient, 51-75 years old
- Active primary care provider at UCLA seen within last 3 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Health Department of Medicine, Quality Office
Westwood, Los Angeles, California, 90095
About this study
Official title: Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates: A Randomized Quality Improvement Trial
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.
Read the 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.
- Being tested
- MyChart Priming Message
- Keywords
- Colorectal Cancer Screening, Colon Cancer, Nudge, Behavior and Behavior Mechanisms, Behavioral Economics, Health Screening
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyChart Priming MessageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal) |
| MyChart Message | Experimental | This group will receive a message via EHR portal informing them about the incoming FIT Kit Receives: Behavioral: MyChart Priming Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Time to screening
Time (months) to screening uptake
Measured: 6 months
Colorectal cancer screening uptake by modality
Rate of completion of CRC screening by modality type
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start28 Aug 2019
- Primary completion20 Sep 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 3,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- UCLA Vatche and Tamar Manoukian Division of Digestive Diseases
- Responsible party
- Principal investigator, Daniel M. Croymans, MD, MBA, MS, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115916
- Sponsor's protocol ID
- FITPrimer
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD for this investigation.
Publications
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.
PubMed 35119462
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates: A Randomized Quality Improvement Trial
- ClinicalTrials.gov ID
- NCT05115916
- Acronym / sponsor ID
- FITPrimer
- Keywords
- Colorectal Cancer Screening, Colon Cancer, Nudge, Behavior and Behavior Mechanisms, Behavioral Economics, Health Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,880 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- UCLA Vatche and Tamar Manoukian Division of Digestive Diseases
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal) |
| MyChart Message | Experimental | Behavioral: MyChart Priming MessageThis group will receive a message via EHR portal informing them about the incoming FIT Kit |
Who may qualify
- Ages
- 51 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Managed care patient, 51-75 years old
- Active primary care provider at UCLA seen within last 3 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyChart Priming MessageIn 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. | Behavioural | MyChart Message |
Primary outcome
Overall Colorectal Cancer Screening Uptake
Time frame: 6 months
Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.
3 secondary outcomes
Time to screening
Time frame: 6 months
Colorectal cancer screening uptake by modality
Time frame: 6 months
Effect of electronic primer message on CRC uptake among participants who opened
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Derived from this study: PubMed 35119462Goshgarian 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.
- Individual participant dataSharing planned: No. We do not plan to share IPD for this investigation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyChart Priming Message in people with Colorectal Cancer and Colorectal Neoplasms, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Colorectal Cancer Screening Uptake (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05115916, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.