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Colorectal Cancer Screening Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters (CRC PROACTIVE)

30 juli 2026 uppdaterad av: Shivan J Mehta, University of Pennsylvania

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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Detaljerad beskrivning

A substantial portion of the United States population remains overdue for preventive care screenings, despite availability of health services. This gap in care persists due to both patient and clinician facing barriers. Patients may not always remain actively engaged with their care team, while clinicians are impacted by time constraints and the complexity of managing multiple care tasks during visits. One population health strategy to address these barriers is visit-based nudges, which are anchored around office visits and use methods such as post-visit texting to patients. One study aimed at improving colorectal cancer screening rates uses visit-based outreach, in addition to direct outreach, to offer patients colonoscopy and fecal immunochemical tests (FIT), which are top tier tests for CRC screening. Another prior study, aimed at improving mammogram completion, utilized pended orders and post-visit texting to increase screening rates by 5 percentage points at six months for intervention patients. Both studies have highlighted the need to create a scalable program for a cohesive patient experience. Building upon our prior and current work and in collaboration with primary care, we propose to develop and evaluate an integrated visit-based preventive health program with nudges to patients using a stepped wedge design, with the goal of implementing this system across primary care practices. This trial will run concurrently with another trial, PROACTIVE (IRB #589571), evaluating pre-visit and post-visit nudges to clinicians and patients to increase screening completion for multiple care gaps identified as high priority by primary care. Because this trial only utilizes post-visit text messaging to the patient and no clinician nudge, it will be a distinct analysis and considered a separate trial.

Studietyp

Interventionell

Inskrivning (Beräknad)

3888

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • University of Pennsylvania Health System

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

All patients must meet the following criteria to be eligible:

  1. Age 18 years or older
  2. A scheduled new or return (non-urgent/sick) primary care visit at one of the study practices
  3. Overdue for colorectal cancer screening by health maintenance
  4. 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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Control Condition
During the control condition, clinics will receive standard of care.
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Colonoscopy Completion (6 months)
Tidsram: 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.
Within 6 months after first eligible primary care visit.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Colonoscopy Completion (12 months)
Tidsram: 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.
Within 12 months after the first eligible primary care visit.
FIT Completion (6 months)
Tidsram: 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)
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Shivan Mehta, University of Pennsylvania

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 juli 2026

Primärt slutförande (Beräknad)

1 mars 2027

Avslutad studie (Beräknad)

1 juni 2027

Studieregistreringsdatum

Först inskickad

3 juni 2026

Först inskickad som uppfyllde QC-kriterierna

3 juni 2026

Första postat (Faktisk)

9 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 26-6819

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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