- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02139722
Patient-Centered Care and Asian Americans
A Patient-Centered Intervention to Increase Screening of Hepatitis B and C Among Asian Americans
Liver cancer and hepatitis B are health disparities for Asian Americans, and hepatitis C is a rising problem. Little is known about how to improve the quality of health care Asian Americans receive for viral hepatitis. Technology, specifically mobile applications, can provide a flexible and efficient way to address these challenges. This project seeks to develop, implement, and test an intervention to increase hepatitis B and C screening for Asian Americans in 2 healthcare systems in San Francisco.
The research team will develop, implement, and evaluate the efficacy of an interactive, patient- centered mobile app for use on a tablet computer to increase hepatitis B and C screening among unscreened Asian Americans age 18 and older. The team will use their experience in health promotion to develop the intervention by working with patients, community leaders and advocates, clinical staff, healthcare providers, and healthcare system administrators from a county safety net system and an academic primary care practice in the San Francisco Bay Area. The mobile application will include video clips with a physician (Video Doctor) addressing patient concerns regarding hepatitis B and C screening in the patient's preferred language, English, Chinese, or Vietnamese. A patient who has not been screened for hepatitis B will answer questions about his or her characteristics and preferences using the mobile application. The mobile application will then show 30-60 seconds video clips with messages that address the patient's responses related to hepatitis B screening and that are delivered by an actor playing a physician. Those who are born between 1945 and 1965 also receive messages about hepatitis C screening. At the end, the tablet computer will generate a provider alert to let the treating provider know what the patient's preferences are regarding testing for viral hepatitis.
Once developed, the intervention will then be used in combination with a physician panel notification and tested against physician panel notification only in a randomized controlled trial to see which approach is better in increasing the rate of hepatitis B and C screening. The team will also work with the 2 healthcare system to ensure that the interventions will be practical and easily adopted once the study is over. The findings of this project will greatly expand understanding about how to use technology- based interventions to improve quality of healthcare in diverse patient populations.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
San Francisco, California, États-Unis, 94143
- University of California, San Francisco
-
San Francisco, California, États-Unis, 94110
- Zuckerberg San Francisco General
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- ages 18+ years
- identifies as Asian
- Asian American, Chinese, or Vietnamese
- speaks English, Chinese (Cantonese), or Vietnamese
- does not have an electronic health record (EHR)-documented HBV screening test (defined as a hepatitis B surface antigen [HBsAg] test).
- we select Chinese and Vietnamese because those are the 2 most common languages spoken by limited English-proficient Asian Americans
Exclusion Criteria:
- dementia or any conditions precluding understanding informed consent or using a touch screen with audio
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Provider Panel Notification (PPN) Alone
The comparison procedures consist of a panel notification given to providers and an audio-visual presentation on diet and exercise given to patients.
|
|
|
Expérimental: Video Doctor, PA + PPN
Video Doctor (VD) and Provider Alert (PA) intervention combined with Provider Panel Notification (PPN)
|
The intervention consists of a Video Doctor and Provider Alert.
For the Video Doctor, we will develop a series of 30-60 seconds video clips, a branching algorithm, and a mobile application linking the baseline survey to the clips.
The Provider Alert is a point-of-care reminder printout generated by the mobile application to facilitate patient-provider communication.
The intervention integrates guidelines, literature, guidance from the Systems Model, our prior work, and input from patients and providers.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
EHR-documented hepatitis B surface antigen (HBsAg) test
Délai: 3 months
|
The main outcome measure is an EHR-documented hepatitis B surface antigen (HBsAg) test at 3 months post-intervention.
We chose screening for hepatitis B because, among adults, particularly immigrants or descendants of immigrants, it is the most important first step in the control of viral hepatitis B and lack of screening remains a significant problem.
While many young adult Asian Americans born in the U.S. or who immigrated at a young age may have been vaccinated for hepatitis B as a child or prior to entering college, pre-vaccination testing may not have been done.
Given the high rates of infection in their parents and the possibility of vertical transmission, all Asian Americans should be tested for chronic hepatitis B using the HBsAg test.
All screening outcomes (test receipt) as well as test ordering by the healthcare providers will be collected from the medical record through the EHRs at 3-month post-intervention.
|
3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Knowledge about hepatitis B virus (HBV) and hepatitis C virus (HCV)
Délai: 3 months
|
Data sources include the self-administered pre-intervention survey via a tablet computer, and the post-intervention phone survey administered by a research assistant, and EHR.
All patient surveys will be done in the patient's preferred language (English, Chinese, or Vietnamese).
Pre- and post-intervention survey data of secondary outcomes include: Knowledge (awareness of HBV and HCV, screening test, modes of transmission); Self-efficacy (perceived confidence in initiating conversation and request screening test from providers); Patient-Provider Communication Experiences (asked provider for HBV or HCV test, discussed HBV or HCV test with provider, receipt of provider recommendation to get a HBV or HCV test).
|
3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Tung T Nguyen, MD, University of California, San Francisco
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Infections à Flaviviridae
- Hépatite, virale, humaine
- Infections à Hépadnaviridae
- Infections par le virus de l'ADN
- Infections à entérovirus
- Infections à Picornaviridae
- Maladies du foie
- Hépatite B
- Hépatite
- Hépatite A
- Hépatite C
Autres numéros d'identification d'étude
- AD-11-4615
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
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .