Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

8. november 2021 oppdatert av: Daniel M. Croymans, MD, MBA, MS, University of California, Los Angeles

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.

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

3880

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • Westwood, California, Forente stater, 90095
        • UCLA Health Department of Medicine, Quality Office

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

49 år til 73 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Standard of Care
This group will receive standard FIT mailer protocol (includes mailed FIT kit plus standardized messaging via EHR portal)
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Time to screening
Tidsramme: 6 months
Time (months) to screening uptake
6 months
Opptak av screening for kolorektal kreft etter modalitet
Tidsramme: 6 måneder
Fullføringsgrad av CRC-screening etter 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. august 2019

Primær fullføring (Faktiske)

20. september 2020

Studiet fullført (Faktiske)

20. desember 2020

Datoer for studieregistrering

Først innsendt

28. oktober 2021

Først innsendt som oppfylte QC-kriteriene

8. november 2021

Først lagt ut (Faktiske)

10. november 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

IPD-planbeskrivelse

We do not plan to share IPD for this investigation.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Kolorektale neoplasmer

Kliniske studier på MyChart Priming Message

3
Abonnere