P3+ Intervention Phase
4. august 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
2200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Colorado
-
Aurora, Colorado, Forente stater, 80045
- CU Center for Midwifery
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Aurora, Colorado, Forente stater, 80045
- CU Maternal and Fetal Medicine Clinic
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Aurora, Colorado, Forente stater, 80045
- University Nurse Midwives
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Boulder, Colorado, Forente stater, 80303
- Boulder Women's Care
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Denver, Colorado, Forente stater, 80218
- St. Joe's Midwives
-
Denver, Colorado, Forente stater, 80220
- Partners in Women's Health at Rose
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Denver, Colorado, Forente stater, 80220
- Rocky Mountain OBGYN
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Edwards, Colorado, Forente stater, 81632
- Colorado Mountain Medical
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Englewood, Colorado, Forente stater, 80113
- Bella Natural Women's Care
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Golden, Colorado, Forente stater, 80401
- Associates in Women's Health
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Thornton, Colorado, Forente stater, 80229
- Women's Health Group Thornton
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Georgia
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Alpharetta, Georgia, Forente stater, 30005
- Atlanta Women's Specialists
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Alpharetta, Georgia, Forente stater, 30005
- Roswell Ob/Gyn
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Athens, Georgia, Forente stater, 30606
- Athens Midwifery
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Athens, Georgia, Forente stater, 30606
- Athens Ob-Gyn
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Athens, Georgia, Forente stater, 30606
- Women's Healthcare Associates of Athens
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Atlanta, Georgia, Forente stater, 30322
- Emory Clinic
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Atlanta, Georgia, Forente stater, 30342
- Riverbend OB/GYN and Counseling
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Cumming, Georgia, Forente stater, 30041
- Peachtree Women's Clinic
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Duluth, Georgia, Forente stater, 30096
- Comprehensive Women's OB/GYN
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Dunwoody, Georgia, Forente stater, 30338
- Dunwoody Ob-Gyn
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Lilburn, Georgia, Forente stater, 30047
- Atlanta Gynecology & Obstetrics
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Tyrone, Georgia, Forente stater, 30290
- Women's Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
Andre navn:
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.
|
|
Eksperimentell: 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.
Andre navn:
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.
|
|
Eksperimentell: 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.
Andre navn:
|
|
Eksperimentell: 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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Daniel Salmon, PhD, MPH, Johns Hopkins Bloomberg School of Public Health
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. juni 2017
Primær fullføring (Faktiske)
6. juli 2020
Studiet fullført (Faktiske)
6. juli 2020
Datoer for studieregistrering
Først innsendt
8. september 2016
Først innsendt som oppfylte QC-kriteriene
8. september 2016
Først lagt ut (Anslag)
13. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. august 2020
Sist bekreftet
1. august 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IRB00090267
- 5R01AI110482-02 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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