- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05115916
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates
Effect of Patient Portal Messaging Before Mailing Fecal Immunochemical Testing Kit on Colorectal Cancer Screening Rates: A Randomized Quality Improvement Trial
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
Westwood, California, Forenede Stater, 90095
- UCLA Health Department of Medicine, Quality Office
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Standard of Care
This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)
|
|
|
Eksperimentel: MyChart Message
This group will receive a message via EHR portal informing them about the incoming FIT Kit
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Colorectal Cancer Screening Uptake
Tidsramme: 6 months
|
Rate of completion of CRC screening by any of the following: FIT, colonoscopy, CT colonography, sigmoidoscopy or FIT-DNA within study period.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to screening
Tidsramme: 6 months
|
Time (months) to screening uptake
|
6 months
|
|
Optagelse af screening for kolorektal cancer efter modalitet
Tidsramme: 6 måneder
|
Gennemførelsesgrad for CRC-screening efter modalitetstype
|
6 måneder
|
|
Effect of electronic primer message on CRC uptake among participants who opened
Tidsramme: 6 months
|
Rate of completion of CRC screening among individuals who received the MyChart electronic primer.
|
6 months
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FITPrimer
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .