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P3+ Intervention Phase

2020년 8월 4일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

2200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Control Site + Control Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to the control group.
행동: Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
다른 이름들:
  • Practice/provider-Level Control
행동: 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.
실험적: Control Site + Intervention Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention.
행동: Control Site
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
다른 이름들:
  • Practice/provider-Level Control
행동: 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.
실험적: Intervention Site + Control Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to the control group.
행동: 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.
행동: 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.
다른 이름들:
  • Practice/provider-Level Intervention
실험적: Intervention Site + Intervention Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention.
행동: 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.
행동: 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.
다른 이름들:
  • Practice/provider-Level Intervention

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of women receiving influenza vaccination
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in maternal vaccine knowledge
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Emory University

협력자

National Institute of Allergy and Infectious Diseases (NIAID)

수사관

  • 수석 연구원: Daniel Salmon, PhD, MPH, Johns Hopkins Bloomberg School of Public Health

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 6월 12일

기본 완료 (실제)

2020년 7월 6일

연구 완료 (실제)

2020년 7월 6일

연구 등록 날짜

최초 제출

2016년 9월 8일

QC 기준을 충족하는 최초 제출

2016년 9월 8일

처음 게시됨 (추정)

2016년 9월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 8월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 8월 4일

마지막으로 확인됨

2020년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • IRB00090267
  • 5R01AI110482-02 (미국 NIH 보조금/계약)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Control Site에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Norway

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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