P3+ Intervention Phase
4 de agosto de 2020 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
2200
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- CU Center for Midwifery
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Aurora, Colorado, Estados Unidos, 80045
- CU Maternal and Fetal Medicine Clinic
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Aurora, Colorado, Estados Unidos, 80045
- University Nurse Midwives
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Boulder, Colorado, Estados Unidos, 80303
- Boulder Women's Care
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Denver, Colorado, Estados Unidos, 80218
- St. Joe's Midwives
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Denver, Colorado, Estados Unidos, 80220
- Partners in Women's Health at Rose
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Denver, Colorado, Estados Unidos, 80220
- Rocky Mountain OBGYN
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Edwards, Colorado, Estados Unidos, 81632
- Colorado Mountain Medical
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Englewood, Colorado, Estados Unidos, 80113
- Bella Natural Women's Care
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Golden, Colorado, Estados Unidos, 80401
- Associates in Women's Health
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Thornton, Colorado, Estados Unidos, 80229
- Women's Health Group Thornton
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Georgia
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Alpharetta, Georgia, Estados Unidos, 30005
- Atlanta Women's Specialists
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Alpharetta, Georgia, Estados Unidos, 30005
- Roswell Ob/Gyn
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Athens, Georgia, Estados Unidos, 30606
- Athens Midwifery
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Athens, Georgia, Estados Unidos, 30606
- Athens Ob-Gyn
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Athens, Georgia, Estados Unidos, 30606
- Women's Healthcare Associates of Athens
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Atlanta, Georgia, Estados Unidos, 30322
- Emory Clinic
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Atlanta, Georgia, Estados Unidos, 30342
- Riverbend OB/GYN and Counseling
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Cumming, Georgia, Estados Unidos, 30041
- Peachtree Women's Clinic
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Duluth, Georgia, Estados Unidos, 30096
- Comprehensive Women's OB/GYN
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Dunwoody, Georgia, Estados Unidos, 30338
- Dunwoody Ob-Gyn
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Lilburn, Georgia, Estados Unidos, 30047
- Atlanta Gynecology & Obstetrics
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Tyrone, Georgia, Estados Unidos, 30290
- Women's Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: Control Site + Control Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to the control group.
|
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Outros nomes:
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.
|
|
Experimental: Control Site + Intervention Patient
The obstetric practice site is randomized to be a control site and the patient is randomized to receive the intervention.
|
Control sites will continue with their standard practice regarding discussing vaccines with their patients.
Outros nomes:
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.
|
|
Experimental: Intervention Site + Control Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to the 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.
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.
Outros nomes:
|
|
Experimental: Intervention Site + Intervention Patient
The obstetric practice site is randomized to be an intervention site and the patient is randomized to receive the intervention.
|
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.
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of women receiving influenza vaccination
Prazo: Up to 34 weeks
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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
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Up to 34 weeks
|
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Number of women receiving pertussis vaccination
Prazo: 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
|
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Timely childhood vaccinations
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in maternal vaccine knowledge
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Daniel Salmon, PhD, MPH, Johns Hopkins Bloomberg School of Public Health
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de junho de 2017
Conclusão Primária (Real)
6 de julho de 2020
Conclusão do estudo (Real)
6 de julho de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
8 de setembro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de setembro de 2016
Primeira postagem (Estimativa)
13 de setembro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de agosto de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de agosto de 2020
Última verificação
1 de agosto de 2020
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- IRB00090267
- 5R01AI110482-02 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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