Colorectal Cancer Screening Preventive Reminder Ordering AssistanCe Via Texting for Improved Visit Encounters (CRC PROACTIVE)
30 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
3888
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania Health System
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control Condition
During the control condition, clinics will receive standard of care.
|
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Colonoscopy Completion (6 months)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Colonoscopy Completion (12 months)
Délai: 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)
Délai: 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)
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Shivan Mehta, University of Pennsylvania
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
28 juillet 2026
Achèvement primaire (Estimé)
1 mars 2027
Achèvement de l'étude (Estimé)
1 juin 2027
Dates d'inscription aux études
Première soumission
3 juin 2026
Première soumission répondant aux critères de contrôle qualité
3 juin 2026
Première publication (Réel)
9 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26-6819
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .