P3+ Intervention Phase
4 augusti 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
2200
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- CU Center for Midwifery
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Aurora, Colorado, Förenta staterna, 80045
- CU Maternal and Fetal Medicine Clinic
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Aurora, Colorado, Förenta staterna, 80045
- University Nurse Midwives
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Boulder, Colorado, Förenta staterna, 80303
- Boulder Women's Care
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Denver, Colorado, Förenta staterna, 80218
- St. Joe's Midwives
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Denver, Colorado, Förenta staterna, 80220
- Partners in Women's Health at Rose
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Denver, Colorado, Förenta staterna, 80220
- Rocky Mountain OBGYN
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Edwards, Colorado, Förenta staterna, 81632
- Colorado Mountain Medical
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Englewood, Colorado, Förenta staterna, 80113
- Bella Natural Women's Care
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Golden, Colorado, Förenta staterna, 80401
- Associates in Women's Health
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Thornton, Colorado, Förenta staterna, 80229
- Women's Health Group Thornton
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Georgia
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Alpharetta, Georgia, Förenta staterna, 30005
- Atlanta Women's Specialists
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Alpharetta, Georgia, Förenta staterna, 30005
- Roswell Ob/Gyn
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Athens, Georgia, Förenta staterna, 30606
- Athens Midwifery
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Athens, Georgia, Förenta staterna, 30606
- Athens Ob-Gyn
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Athens, Georgia, Förenta staterna, 30606
- Women's Healthcare Associates of Athens
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Atlanta, Georgia, Förenta staterna, 30322
- Emory Clinic
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Atlanta, Georgia, Förenta staterna, 30342
- Riverbend OB/GYN and Counseling
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Cumming, Georgia, Förenta staterna, 30041
- Peachtree Women's Clinic
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Duluth, Georgia, Förenta staterna, 30096
- Comprehensive Women's OB/GYN
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Dunwoody, Georgia, Förenta staterna, 30338
- Dunwoody Ob-Gyn
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Lilburn, Georgia, Förenta staterna, 30047
- Atlanta Gynecology & Obstetrics
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Tyrone, Georgia, Förenta staterna, 30290
- Women's Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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.
Andra namn:
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.
|
|
Experimentell: 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.
Andra namn:
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.
|
|
Experimentell: 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.
Andra namn:
|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of women receiving influenza vaccination
Tidsram: 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
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Up to 34 weeks
|
|
Number of women receiving pertussis vaccination
Tidsram: Up to 34 weeks
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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
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Up to 34 weeks
|
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Timely childhood vaccinations
Tidsram: 20 months
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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.
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20 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in maternal vaccine knowledge
Tidsram: Up to 106 weeks (baseline visit until 18 months post delivery)
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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)
|
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Changes in maternal vaccine attitudes
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Daniel Salmon, PhD, MPH, Johns Hopkins Bloomberg School of Public Health
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 juni 2017
Primärt slutförande (Faktisk)
6 juli 2020
Avslutad studie (Faktisk)
6 juli 2020
Studieregistreringsdatum
Först inskickad
8 september 2016
Först inskickad som uppfyllde QC-kriterierna
8 september 2016
Första postat (Uppskatta)
13 september 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 augusti 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 augusti 2020
Senast verifierad
1 augusti 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- IRB00090267
- 5R01AI110482-02 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
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