Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

P3+ Intervention Phase

4 agosto 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Control Site + Control Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to the control group.
Comportamentale: Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Altri nomi:
  • Practice/provider-Level Control
Comportamentale: 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.
Sperimentale: Control Site + Intervention Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention.
Comportamentale: Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Altri nomi:
  • Practice/provider-Level Control
Comportamentale: 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.
Sperimentale: Intervention Site + Control Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group.
Comportamentale: 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.
Comportamentale: 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.
Altri nomi:
  • Practice/provider-Level Intervention
Sperimentale: Intervention Site + Intervention Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention.
Comportamentale: 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.
Comportamentale: 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.
Altri nomi:
  • Practice/provider-Level Intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of women receiving influenza vaccination
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in maternal vaccine knowledge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Emory University

Collaboratori

National Institute of Allergy and Infectious Diseases (NIAID)

Investigatori

  • Investigatore principale: Daniel Salmon, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

12 giugno 2017

Completamento primario (Effettivo)

6 luglio 2020

Completamento dello studio (Effettivo)

6 luglio 2020

Date di iscrizione allo studio

Primo inviato

8 settembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

8 settembre 2016

Primo Inserito (Stima)

13 settembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 agosto 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 agosto 2020

Ultimo verificato

1 agosto 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • IRB00090267
  • 5R01AI110482-02 (Sovvenzione/contratto NIH degli Stati Uniti)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Control Site

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in United States

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi