- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07716280
Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics (LUNG-IS)
Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics (LUNG-IS) - PATIENT
The long-term goal of this program of research is to increase the reach of Lung Cancer Screening (LCS) among low-resource healthcare settings and populations. The proposed project, LUNG-IS, is a mixed-methods, pre-post quasi-experimental design conducted in three Utah safety-net healthcare system clinics.
LUNG-IS employs a comprehensive conceptual model with theories, models, and frameworks of implementation and behavioral science, uses rigorous mixed-methods to evaluate factors that influence implementation of LCS, and uses patient navigation to facilitate clinic-community linkages.
LUNG-IS leverages existing pathways to care and Centralized Hub infrastructure that enables eligibility assessment, LCS Shared Decision Making (SDM) with clinical decision support, screening referral, and screening logistics assistance to help overcome barriers to LCS completion. The Centralized Hub model uses ubiquitous technologies (i.e., text messaging/telehealth) to enable patients to be assessed for LCS eligibility, engage in SDM if eligible, and be referred for LCS. For patients who decide to complete LCS, they will be provided patient navigation via Community Health Workers designed to address logistical barriers, hesitancy, and financial constraints around completing LCS.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Indy Li, MS
- Numéro de téléphone: 801-213-5697
- E-mail: indy.li@hci.utah.edu
Lieux d'étude
-
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- Recrutement
- Huntsman Cancer Institute/ University of Utah
-
Contact:
- Indy Li, MS
- Numéro de téléphone: 801-213-5697
- E-mail: indy.li@hci.utah.edu
-
Chercheur principal:
- Chelsey Schlechter, MPH, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Current or former, male and female, smokers.
- Age 50-80.
- Primary language English or Spanish.
- Have a phone that can send/receive text messages.
Exclusion Criteria:
- Patients who have never smoked.
- Patients who are under the age of 50 or above the age of 80.
- Primary language other than English or Spanish.
- Do not have access to a phone that can send/receive text messages.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Stage 1: TM+
Basic text messages sent directly to the patient's cell phone.
|
Basic text messages sent directly to the patient's cell phone.
|
|
Autre: Stage 1: TM+, CA
Basic text messages sent directly to the patient's cell phone.
Also includes the option for chat bot to answer frequently asked LCS questions.
|
Basic text messages sent directly to the patient's cell phone.
Chat bot to answer frequently asked LCS questions.
|
|
Autre: Stage 1: TM+, Video
Basic text messages sent directly to the patient's cell phone.
Also includes the option for an educational video about LCS.
|
Basic text messages sent directly to the patient's cell phone.
Educational video about LCS.
|
|
Autre: Stage 1: TM+, CA, Video
Basic text messages sent directly to the patient's cell phone. Also includes the option for chat bot to answer frequently asked LCS questions and option for educational video about LCS. Patients who complete SDM and are referred to LCS will also be assigned to one of the following conditions. Descriptions of these conditions are as follows: |
Basic text messages sent directly to the patient's cell phone.
Chat bot to answer frequently asked LCS questions.
Educational video about LCS.
|
|
Autre: Stage 2: TM+, RPN
Patients who complete SDM and are referred to LCS may be assigned to this condition Patients will receive basic text messages and reactive patient navigation to help get to the LCS appointment. |
Basic text messages sent directly to the patient's cell phone.
Reactive patient navigation to help get to the LCS appointment.
|
|
Autre: Stage 2:TM+, PPN
Patients who complete SDM and are referred to LCS may be assigned to this condition Patients will receive basic text messages and proactive patient navigation to help get to the LCS appointment. Patients who need transportation financial assistance will receive transportation vouchers to help get them to and from their LCS appointment. |
Basic text messages sent directly to the patient's cell phone.
Proactive patient navigation to help get to the LCS appointment.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Impact of Implementation Strategies on Lung Cancer Screening (LCS) eligibility screening
Délai: up to 15 weeks after study enrollment
|
Evaluate the impact of implementation strategies on Lung Cancer Screening (LCS) eligibility screening.
This outcome measure will report the proportion of participants who complete LCS eligibility screening.
|
up to 15 weeks after study enrollment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Impact of Implementation Strategies on LCS Shared Decision Making (SDM) completion
Délai: up to 7 weeks after completion of LCS eligibility screen
|
Evaluate the impact of implementation strategies on Shared Decision Making (SDM) completion.
This outcome measure will report the proportion of patients who complete SDM.
|
up to 7 weeks after completion of LCS eligibility screen
|
|
Impact of Implementation Strategies on LCS Completion
Délai: up to 6 months after placement of LCS referral
|
Evaluate the impact of implementation strategies on LCS completion.
This outcome measure will report the proportion of participants who complete LCS.
|
up to 6 months after placement of LCS referral
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 187448
- 1U48DP006855-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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