Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441487
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-22
Brief Title:
mPATH-Cloud for Colorectal Cancer Screening
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Evaluating a Remotely Delivered Digital Health CRC Screening Intervention Among Racially Diverse Patients of a Community Health Center
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mPATH-Cloud
Brief Summary:
This study assesses the effectiveness of colorectal cancer CRC screening intervention mobile Patient Technology for Health mPATH-Cloud compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce USPSTF The trial randomly selects and enrolls 1000 eligible subjects served by one federally qualified health center FQHC in North Carolina Subjects are randomized to two study arms Usual Care Arm 1 or Mobile Health Decision Support Arm 2
Usual care consists of a visit-based screening recommendation to complete a stool test eg FOBT FIT Cologuard or referral to a screening colonoscopy Subjects randomized to the Mobile Health Decision Support Arm 2 are sent a message by text or US mail depending on their preferred communication mode as indicated in the electronic health record EHR to visit the mPATH-Cloud website Subjects who engage with mPATH-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test FIT or colonoscopy that they would like to receive After watching the video subjects can choose a CRC screening test Their primary care provider at the FQHC orders the appropriate test and where indicated refers the subjects to a colonoscopy Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address
The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review A completed screening is any of the following colonoscopy completion regardless of indication 2 at least one FIT test with a normal result or diagnostic colonoscopy following an abnormal FIT result We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm Arm 2
This study includes up to three annual rounds of screening eligibility assessment and outreach Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time During the 3-year intervention phase Arm 1 receives usual care only
Usual care consists of a visit-based screening recommendation to complete a stool test eg FOBT FIT Cologuard or referral to a screening colonoscopy Subjects randomized to the Mobile Health Decision Support Arm 2 are sent a message by text or US mail depending on their preferred communication mode as indicated in the electronic health record EHR to visit the mPATH-Cloud website Subjects who engage with mPATH-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test FIT or colonoscopy that they would like to receive After watching the video subjects can choose a CRC screening test Their primary care provider at the FQHC orders the appropriate test and where indicated refers the subjects to a colonoscopy Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address
The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review A completed screening is any of the following colonoscopy completion regardless of indication 2 at least one FIT test with a normal result or diagnostic colonoscopy following an abnormal FIT result We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm Arm 2
This study includes up to three annual rounds of screening eligibility assessment and outreach Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time During the 3-year intervention phase Arm 1 receives usual care only
Detailed Description:
Subjects randomized to the Mobile Health Decision Support intervention arm Arm 2 receive a link to mobile Patient Technology for Health mPATH-Cloud a digital health platform designed to alleviate the implementation burden on clinical teams by automating many key steps in the CRC screening process If the subject uses mPATH-Cloud to select a screening test mPATH-Cloud notifies the subjects primary care provider at the FQHC Subjects who request colonoscopy are then referred by their primary care provider to colonoscopy as appropriate Subjects who request FIT receive a FIT mailed to their home
Primary outcome assessment To assess intervention effectiveness CRC screening completion within 6 months of randomization primary outcome is assessed by EHR chart review Screening completion is defined as any of the following colonoscopy completion regardless of indication at least one FIT test with a normal FIT result or diagnostic colonoscopy following an abnormal FIT result
Secondary outcome assessment To assess intervention effectiveness on adherence to USPSTF recommendations over time secondary outcome the Mobile Health Decision Support intervention is offered annually to Arm 2 subjects for up to 3 consecutive years so long as the subject remains eligible and due for CRC screening as determined by EHR review
CRC screening up-to-datedness will be assessed by EHR chart review over a period of three consecutive years FIT should be repeated annually and colonoscopy typically only needs to be repeated once every 10 years Thus subjects will be assigned one year per annual FIT completed eg FIT in years 1 2 and 3 would be assigned 3 years FIT in year 1 and 3 would be assigned 2 years and up to 3 years for colonoscopy depending on the year received eg colonoscopy in year 1 would be assigned 3 years colonoscopy in year 3 would be assigned 1 year Subjects remain in their originally assigned study arms for the duration of up to three annual rounds of CRC screening outreach
Implementation assessment exploratory outcome This study will identify implementation processes and outcomes that will impact future dissemination and scalability After the trial phase concludes researchers will interview a subsample of up to 50 subjects to understand factors associated with CRC screening completion among subjects with varying needs and preferences
Primary outcome assessment To assess intervention effectiveness CRC screening completion within 6 months of randomization primary outcome is assessed by EHR chart review Screening completion is defined as any of the following colonoscopy completion regardless of indication at least one FIT test with a normal FIT result or diagnostic colonoscopy following an abnormal FIT result
Secondary outcome assessment To assess intervention effectiveness on adherence to USPSTF recommendations over time secondary outcome the Mobile Health Decision Support intervention is offered annually to Arm 2 subjects for up to 3 consecutive years so long as the subject remains eligible and due for CRC screening as determined by EHR review
CRC screening up-to-datedness will be assessed by EHR chart review over a period of three consecutive years FIT should be repeated annually and colonoscopy typically only needs to be repeated once every 10 years Thus subjects will be assigned one year per annual FIT completed eg FIT in years 1 2 and 3 would be assigned 3 years FIT in year 1 and 3 would be assigned 2 years and up to 3 years for colonoscopy depending on the year received eg colonoscopy in year 1 would be assigned 3 years colonoscopy in year 3 would be assigned 1 year Subjects remain in their originally assigned study arms for the duration of up to three annual rounds of CRC screening outreach
Implementation assessment exploratory outcome This study will identify implementation processes and outcomes that will impact future dissemination and scalability After the trial phase concludes researchers will interview a subsample of up to 50 subjects to understand factors associated with CRC screening completion among subjects with varying needs and preferences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA260822 | NIH | None | httpsreporternihgovquickSearchR01CA260822 |