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P3+ Intervention Phase

4. august 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Control Site + Control Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to the control group.
Adfærdsmæssigt: Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Andre navne:
  • Practice/provider-Level Control
Adfærdsmæssigt: 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.
Eksperimentel: Control Site + Intervention Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention.
Adfærdsmæssigt: Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Andre navne:
  • Practice/provider-Level Control
Adfærdsmæssigt: 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.
Eksperimentel: Intervention Site + Control Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • Practice/provider-Level Intervention
Eksperimentel: Intervention Site + Intervention Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • Practice/provider-Level Intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of women receiving influenza vaccination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in maternal vaccine knowledge
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Emory University

Samarbejdspartnere

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Ledende efterforsker: Daniel Salmon, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. juni 2017

Primær færdiggørelse (Faktiske)

6. juli 2020

Studieafslutning (Faktiske)

6. juli 2020

Datoer for studieregistrering

Først indsendt

8. september 2016

Først indsendt, der opfyldte QC-kriterier

8. september 2016

Først opslået (Skøn)

13. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • IRB00090267
  • 5R01AI110482-02 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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