- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07636174
Colorectal Cancer Screening Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters (CRC PROACTIVE)
Colorectal cancer (CRC) is the second leading cause of cancer death in the United States. A substantial portion of the United States population remains overdue for screening, despite availability and insurance coverage of preventive health services. Barriers for completion and remaining up to date with screening include patients not remaining actively engaged with their care team, time constraints during office visits, and operational strain. This project aims to implement and evaluate a primary care visit-based outreach program that improves patient follow through on completion of overdue CRC screening.
This will be a 6 month, stepped-wedge, pragmatic trial conducted at Penn Medicine.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Health System
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
All patients must meet the following criteria to be eligible:
- Age 18 years or older
- A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
- Overdue for colorectal cancer screening by health maintenance
- Ordered for FIT or Colonoscopy at the eligible visit
Exclusion Criteria:
As this trial is integrated with routine clinical operations, there will be no exclusion criteria other than already having an eligible visit at some point during the trial duration with an order for FIT or Colonoscopy.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Control Condition
During the control condition, clinics will receive standard of care.
|
|
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Eksperimentell: Active Intervention
During the active intervention, clinics will receive patient facing nudges.
Patient nudges will be post-visit text message reminders about their overdue CRC screening.
|
All patients who complete their primary care visit and whose provider signed a colonoscopy or FIT order at their office visit will be sent post-visit text messages 7 and 14 days after visit completion, if they have not yet scheduled or completed their overdue CRC screening.
The messages delivered at 7 and 14 days will remind patients that appointments for their colonoscopy are available for them and provide phone number(s) to call for scheduling, or the messages will remind patients to return their FIT kit in the mail.
We will translate patient text messages into Spanish for patients who require an interpreter according to their language preferences in the EHR.
Patients will also have the option to engage with a bi-directional support menu via text message.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Colonoscopy Completion (6 months)
Tidsramme: Within 6 months after first eligible primary care visit.
|
The primary outcome is completion of a colonoscopy within 6 months of the first eligible primary care visit at which a colonoscopy was ordered by the PCP.
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Within 6 months after first eligible primary care visit.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Colonoscopy Completion (12 months)
Tidsramme: Within 12 months after the first eligible primary care visit.
|
The secondary outcome is completion of a colonoscopy within 12 months of the first eligible primary care visit with an order for colonoscopy.
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Within 12 months after the first eligible primary care visit.
|
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FIT Completion (6 months)
Tidsramme: Within 6 months after the first eligible primary care visit.
|
The secondary outcome is completion of a fecal immunochemical test (FIT) within 6 months of the first eligible primary care visit with an order for a FIT.
|
Within 6 months after the first eligible primary care visit.
|
|
FIT Completion (12 months)
Tidsramme: Within 12 months after the first eligible primary care visit.
|
The secondary outcome is completion of FIT within 12 months of the first eligible primary care visit with an order for a FIT.
|
Within 12 months after the first eligible primary care visit.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Shivan Mehta, University of Pennsylvania
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-6819
Plan for individuelle deltakerdata (IPD)
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