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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01IP001110-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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The purpose of this study is to evaluate the AFIX-OB model to determine its impact on the change in flu and pertussis (Tdap) uptake, provider knowledge, attitudes and beliefs, and patient knowledge, attitudes and beliefs regarding maternal vaccination. The structure of the model and quality improvement interventions are guided by theory including the elaboration likelihood model and P3 model. These quality improvement measures will be implemented in OB clinics within the Yale New Haven Health System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFIX-OB Intervention Arm | Experimental | Practices randomized to this arm will choose from a suite of quality improvement interventions that address patient, provider, and practice-level factors relating to maternal vaccination. |
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| Control Arm | No Intervention | Practices randomized to this arm will continue to provide their normal standard of care to pregnant patients at their practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AFIX-OB Quality Improvement Package | Behavioral | Practices randomized to the intervention arm will be provided with a package of core and supplemental quality improvement interventions to choose from so that the most effective combination for their practice is implemented. Each practice will be required to implement a tablet-based educational app for patients, and evidence based online educational module for providers, standing order protocol, and a reminder/recall protocol. They can then choose to also use flyers and posters in their waiting rooms, standardized talking points for maternal immunization for the providers, educational content for the practice website, and laminated and highlighted CDC Vaccine Information Sheets. The recruited patients and providers at the practice will be given a baseline and follow-up survey to assess their knowledge, attitudes, and beliefs towards maternal immunization. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maternal Influenza Uptake | Immunization rates for each practice will be collected through JDAT or a random chart review. | Baseline and one year after implementation |
| Change in Maternal Tdap Uptake | Immunization rates for each practice will be collected through JDAT or a random chart review. | Baseline and one year after implementation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Vaccine Knowledge | Data on patient knowledge regarding vaccines will be collected from enrolled participants at the beginning of the study and following the implementation of the intervention via a 10-15 minute survey. | Baseline and one year after implementation |
| Change in Provider Vaccine Knowledge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06512 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10437765 | Background | LeBaron CW, Mercer JT, Massoudi MS, Dini E, Stevenson J, Fischer WM, Loy H, Quick LS, Warming JC, Tormey P, DesVignes-Kendrick M. Changes in clinic vaccination coverage after institution of measurement and feedback in 4 states and 2 cities. Arch Pediatr Adolesc Med. 1999 Aug;153(8):879-86. doi: 10.1001/archpedi.153.8.879. | |
| 26044495 | Background | Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortes M, Whitney EA, Berkelman RL, Orenstein WA, Omer SB. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season. Vaccine. 2015 Jul 9;33(30):3571-9. doi: 10.1016/j.vaccine.2015.05.048. Epub 2015 Jun 1. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2020 | Feb 8, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention. |
| Baseline and one year after implementation |
| Change in Patient Vaccine Attitudes | Data on patient attitudes regarding vaccines will be collected from enrolled participants at the beginning of the study and following the implementation of the intervention via a 10-15 minute survey. | Baseline and one year after implementation |
| Change in Patient Vaccine Beliefs | Data on patient beliefs regarding vaccines will be collected from enrolled participants at the beginning of the study and following the implementation of the intervention via a 10-15 minute survey. | Baseline and one year after implementation |
| Change in Provider Vaccine Beliefs | Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention. | Baseline and one year after implementation |
| Change in Provider Vaccine Attitudes | Providers in both study arms will complete baseline and follow-up surveys pre-and post-intervention. | Baseline and one year after implementation |
| 10186655 | Background | Dini EF, Chaney M, Moolenaar RL, LeBaron CW. Information as intervention: how Georgia used vaccination coverage data to double public sector vaccination coverage in seven years. J Public Health Manag Pract. 1996 Winter;2(1):45-9. doi: 10.1097/00124784-199600210-00008. |
| 9949744 | Background | Fairbrother G, Hanson KL, Friedman S, Butts GC. The impact of physician bonuses, enhanced fees, and feedback on childhood immunization coverage rates. Am J Public Health. 1999 Feb;89(2):171-5. doi: 10.2105/ajph.89.2.171. |
| 30503657 | Background | Frew PM, Murden R, Mehta CC, Chamberlain AT, Hinman AR, Nowak G, Mendel J, Aikin A, Randall LA, Hargreaves AL, Omer SB, Orenstein WA, Bednarczyk RA. Development of a US trust measure to assess and monitor parental confidence in the vaccine system. Vaccine. 2019 Jan 7;37(2):325-332. doi: 10.1016/j.vaccine.2018.09.043. Epub 2018 Nov 30. |
| 30260946 | Background | Kahn KE, Black CL, Ding H, Williams WW, Lu PJ, Fiebelkorn AP, Havers F, D'Angelo DV, Ball S, Fink RV, Devlin R. Influenza and Tdap Vaccination Coverage Among Pregnant Women - United States, April 2018. MMWR Morb Mortal Wkly Rep. 2018 Sep 28;67(38):1055-1059. doi: 10.15585/mmwr.mm6738a3. |
| 24996123 | Background | Yuen CY, Tarrant M. Determinants of uptake of influenza vaccination among pregnant women - a systematic review. Vaccine. 2014 Aug 6;32(36):4602-13. doi: 10.1016/j.vaccine.2014.06.067. Epub 2014 Jul 2. |
| 27317458 | Background | Myers KL. Predictors of maternal vaccination in the United States: An integrative review of the literature. Vaccine. 2016 Jul 25;34(34):3942-9. doi: 10.1016/j.vaccine.2016.06.042. Epub 2016 Jun 18. |
| 30587042 | Background | Ellingson MK, Dudley MZ, Limaye RJ, Salmon DA, O'Leary ST, Omer SB. Enhancing uptake of influenza maternal vaccine. Expert Rev Vaccines. 2019 Feb;18(2):191-204. doi: 10.1080/14760584.2019.1562907. Epub 2019 Jan 28. |
| 26829978 | Background | O'Leary ST, Pyrzanowski J, Brewer SE, Dickinson LM, Dempsey AF. Evidence-based vaccination strategies in obstetrics and gynecology settings: Current practices and methods for assessment. Hum Vaccin Immunother. 2016 Apr 2;12(4):866-71. doi: 10.1080/21645515.2015.1130194. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |