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P3+ Intervention Phase

4 août 2020 mis à jour par: Robert Bednarczyk, Emory University

A Comprehensive Pre-Natal Intervention to Increase Vaccine Coverage (P3+): Practice, Provider, Patient Level Interventions

This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time. This study builds off of a prior intervention, developed by Emory, at the practice, provider, and patient levels (P3) to develop, implement and evaluate an enhanced intervention (P3+) to improve vaccination uptake among pregnant women, and later, their children.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This study will address vaccine uptake both for pregnant women and for their children, through 20 months of age, to test the hypothesis that exposure to the P3+ intervention package will increase the likelihood a pregnant woman gets herself vaccinated against influenza and pertussis before delivery and get her child vaccinated on time.

This study uses a multi-level factorial design which randomizes at both the practice and the patient level. Obstetric practices in Georgia and Colorado will be randomized to be either an intervention practice or a control practice. The women recruited in the practices and enrolled in the study will be randomly assigned to the intervention arm or the control arm.

Women randomized to the intervention arm will complete a computer-based questionnaire (administered via iPad with a preloaded study app) which asks for their basic demographic and contact information and asks questions about their vaccine knowledge, attitudes, and beliefs. Immediately following the questionnaire, participants will receive the individual level intervention (videos providing information on vaccines) on the same iPad. In order to best answer their questions and not provide information beyond the scope of what the study participants need or want, the videos provided to each participant will be selected based on responses to the survey questions. There are 6 videos: one discusses the dangers of the diseases prevented by vaccines, and the others address specific vaccine concerns (concerns include vaccine ingredients, children receiving simultaneous vaccines (multiple vaccines at one time), and the safety of receiving the tdap or flu vaccine during pregnancy). If the participant does not have any concerns, they will only see the video about dangers of vaccine preventable diseases. Participants expressing concerns in the survey will receive up to two videos addressing those concerns, based on an order of priority determined by the study researchers.

Women randomized to the control arm will also complete a computer-based questionnaire which includes their personal information and vaccine knowledge, attitudes, and beliefs questions but will then continue to receive usual prenatal care rather than view informational videos.

All enrolled women complete two follow-up surveys when their children are 30 days and 18 months of age.

Type d'étude

Interventionnel

Inscription (Réel)

2200

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

  • États-Unis
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • CU Center for Midwifery
      • Aurora, Colorado, États-Unis, 80045
        • CU Maternal and Fetal Medicine Clinic
      • Aurora, Colorado, États-Unis, 80045
        • University Nurse Midwives
      • Boulder, Colorado, États-Unis, 80303
        • Boulder Women's Care
      • Denver, Colorado, États-Unis, 80218
        • St. Joe's Midwives
      • Denver, Colorado, États-Unis, 80220
        • Partners in Women's Health at Rose
      • Denver, Colorado, États-Unis, 80220
        • Rocky Mountain OBGYN
      • Edwards, Colorado, États-Unis, 81632
        • Colorado Mountain Medical
      • Englewood, Colorado, États-Unis, 80113
        • Bella Natural Women's Care
      • Golden, Colorado, États-Unis, 80401
        • Associates in Women's Health
      • Thornton, Colorado, États-Unis, 80229
        • Women's Health Group Thornton
    • Georgia
      • Alpharetta, Georgia, États-Unis, 30005
        • Atlanta Women's Specialists
      • Alpharetta, Georgia, États-Unis, 30005
        • Roswell Ob/Gyn
      • Athens, Georgia, États-Unis, 30606
        • Athens Midwifery
      • Athens, Georgia, États-Unis, 30606
        • Athens Ob-Gyn
      • Athens, Georgia, États-Unis, 30606
        • Women's Healthcare Associates of Athens
      • Atlanta, Georgia, États-Unis, 30322
        • Emory Clinic
      • Atlanta, Georgia, États-Unis, 30342
        • Riverbend OB/GYN and Counseling
      • Cumming, Georgia, États-Unis, 30041
        • Peachtree Women's Clinic
      • Duluth, Georgia, États-Unis, 30096
        • Comprehensive Women's OB/GYN
      • Dunwoody, Georgia, États-Unis, 30338
        • Dunwoody Ob-Gyn
      • Lilburn, Georgia, États-Unis, 30047
        • Atlanta Gynecology & Obstetrics
      • Tyrone, Georgia, États-Unis, 30290
        • Women's Medical Center

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

18 ans à 50 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  • Have not previously participated in this study
  • Currently pregnant
  • Up to 26 weeks gestational age
  • Able to understand and communicate in English

Exclusion Criteria:

  • Have received pertussis vaccine during the current pregnancy

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 factorielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: Control Site + Control Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to the control group.
Comportemental: Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Autres noms:
  • Practice/provider-Level Control
Comportemental: Patient-level Control Group
Participants randomized the control arm will complete a computer-based questionnaire, on an iPad with a preloaded app. The questionnaire asks about vaccine knowledge, attitudes, and beliefs and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questionnaire includes questions requiring a "yes" or "no" response, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), questions to capture the vaccines participants plan to get for themselves and their children, and open-ended questions.
Expérimental: Control Site + Intervention Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention.
Comportemental: Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Autres noms:
  • Practice/provider-Level Control
Comportemental: Patient-level Intervention Group
Participants randomized to the intervention arm will complete a computer-based questionnaire on an iPad with a preloaded app, prior to watching informational videos covering topics on maternal and childhood vaccines. The questionnaire asks about vaccine knowledge, attitudes, beliefs, and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questions require "yes" or "no" responses, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), and open-ended responses. After watching at least one informational video, the participant completes a questionnaire asking about the perceived usefulness of the app, degree of agreement with the vaccine information presented in the video, and ways to make the app more useful to participants.
Expérimental: Intervention Site + Control Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group.
Comportemental: Patient-level Control Group
Participants randomized the control arm will complete a computer-based questionnaire, on an iPad with a preloaded app. The questionnaire asks about vaccine knowledge, attitudes, and beliefs and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questionnaire includes questions requiring a "yes" or "no" response, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), questions to capture the vaccines participants plan to get for themselves and their children, and open-ended questions.
Comportemental: Intervention Site
Intervention Sites will each assign a Vaccine Champion and will have Assessment, Feedback, Incentives, and eXchange (AFIX) visits. AFIX is a quality improvement program to raise immunization coverage levels, reduce missed opportunities to vaccinate, and improve standards of practices at the provider level. A Continuing Medical Education (CME) module will be given to all providers, covering the recommended maternal vaccinations and how to talk to patients about vaccines. Intervention sites will have access to written materials covering all recommended maternal and infant vaccinations, the diseases they prevent, potential adverse reactions and common patient questions with talking points and references for each topic.
Autres noms:
  • Practice/provider-Level Intervention
Expérimental: Intervention Site + Intervention Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention.
Comportemental: Patient-level Intervention Group
Participants randomized to the intervention arm will complete a computer-based questionnaire on an iPad with a preloaded app, prior to watching informational videos covering topics on maternal and childhood vaccines. The questionnaire asks about vaccine knowledge, attitudes, beliefs, and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questions require "yes" or "no" responses, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), and open-ended responses. After watching at least one informational video, the participant completes a questionnaire asking about the perceived usefulness of the app, degree of agreement with the vaccine information presented in the video, and ways to make the app more useful to participants.
Comportemental: Intervention Site
Intervention Sites will each assign a Vaccine Champion and will have Assessment, Feedback, Incentives, and eXchange (AFIX) visits. AFIX is a quality improvement program to raise immunization coverage levels, reduce missed opportunities to vaccinate, and improve standards of practices at the provider level. A Continuing Medical Education (CME) module will be given to all providers, covering the recommended maternal vaccinations and how to talk to patients about vaccines. Intervention sites will have access to written materials covering all recommended maternal and infant vaccinations, the diseases they prevent, potential adverse reactions and common patient questions with talking points and references for each topic.
Autres noms:
  • Practice/provider-Level Intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of women receiving influenza vaccination
Délai: Up to 34 weeks
Whether or not the participant chose to receive the flu vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms
Up to 34 weeks
Number of women receiving pertussis vaccination
Délai: Up to 34 weeks
Whether or not the participant chose to receive the pertussis vaccine during pregnancy (between the baseline visit and birth of infant) will be compared between study arms
Up to 34 weeks
Timely childhood vaccinations
Délai: 20 months
Childhood vaccination will be assessed as timely uptake of childhood vaccines by calculating average days under-vaccinated. The total number of days under-vaccinated will be divided by the number of vaccines a child should have received, according to the Advisory Committee on Immunization Practices (ACIP) schedule, to give the average number of days under-vaccinated across all recommended vaccines. This can range from 0 to 415 days in the first 20 months of life. The average number of days under-vaccinated will be modeled as a continuous variable, and the distribution of days under-vaccinated will be evaluated, in total and by vaccine where possible, to identify specific patterns of interest for follow-up.
20 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in maternal vaccine knowledge
Délai: Up to 106 weeks (baseline visit until 18 months post delivery)
Maternal vaccine knowledge will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.
Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine attitudes
Délai: Up to 106 weeks (baseline visit until 18 months post delivery)
Maternal vaccine attitudes will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.
Up to 106 weeks (baseline visit until 18 months post delivery)
Changes in maternal vaccine beliefs
Délai: Up to 106 weeks (baseline visit until 18 months post delivery)
Maternal vaccine beliefs will be collected by the app surveys at different time periods, including before receiving the patient-level intervention, immediately after receiving the intervention, and 30 days and 18 months after the birth of the child. The survey questions assessing these outcomes will most often be measured on a Likert scale. Changes in these outcomes over time will be compared between mothers in the different study arms.
Up to 106 weeks (baseline visit until 18 months post delivery)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Emory University

Collaborateurs

National Institute of Allergy and Infectious Diseases (NIAID)

Les enquêteurs

  • Chercheur principal: Daniel Salmon, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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)

12 juin 2017

Achèvement primaire (Réel)

6 juillet 2020

Achèvement de l'étude (Réel)

6 juillet 2020

Dates d'inscription aux études

Première soumission

8 septembre 2016

Première soumission répondant aux critères de contrôle qualité

8 septembre 2016

Première publication (Estimation)

13 septembre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 août 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 août 2020

Dernière vérification

1 août 2020

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • IRB00090267
  • 5R01AI110482-02 (Subvention/contrat des NIH des États-Unis)

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 .

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