Clinical trial NCT02994290: Evaluation of the Implementation and Effectiveness of IPP-HPV
Official title: Evaluation of the Implementation and Effectiveness of a Pilot Quality Improvement Program to Increase HPV Vaccine Uptake: Inpatient Postpartum HPV Immunization (IPP-HPV) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Vaccination
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-12-15
Enrollment: 817
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the proposed pilot study is to assess the implementation of IPP-HPV immunization at Yale New Haven Hospital (YNHH) and to identify potential barriers to and facilitators of this intervention to optimize its feasibility and effectiveness. It is imperative that innovative interventions be developed to achieve comprehensive utilization of this highly effective vaccine to reduce rates of HPV infection, lower rates of cervical and other HPV associated cancers, and address cancer disparities.

Detailed description: Administration of the HPV vaccine during the inpatient postpartum hospital stay has the potential to be an innovative intervention to improve HPV immunization rates. Following onset of pregnancy, the postpartum period becomes the next available opportunity to immunize with the HPV vaccine, which is safe in breastfeeding women. The benefits of such an intervention include a focus on women engaged with the health care system who are often highly motivated to invest in their personal health.

Specific Aims Aim 1: To evaluate receptivity and concerns of postpartum women with receiving the HPV vaccine during the inpatient postpartum admission as part of the Inpatient Postpartum HPV Immunization Quality Improvement Program (IPP-HPV).

Aim 2: To evaluate receptivity and concerns of healthcare providers with inpatient postpartum HPV immunization as part of IPP-HPV and to identify facilitators of and barriers to its implementation.

Aim 3: To assess the uptake and effectiveness of a Pilot Quality Improvement Program to increase HPV vaccine uptake (IPP-HPV) for Yale New Haven Hospital (YNHH) Women's Center and Center for Women's Health and Midwifery (CWHM) postpartum patients ≤ 26 years of age who deliver at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC).

Eligibility criteria: Inclusion Criteria:

* Women participating in the IPP-HPV Quality Improvement Program:
* Postpartum YNHH Women's Center and CWHM patients
* ≤ 26 years at time of delivery who deliver at YNHH YSC or SRC
* Have not already received 3 doses of the HPV vaccine at time of delivery
* Fluent in English or Spanish
* Able and willing to provide consent

AND

* Yale New Haven Hospital (YNHH) Women's Center and Center for Women's Health and Midwifery (CWHM) postpartum patients
* ≤ 26 years of age
* Delivered at YNHH York Street Campus (YSC) or Saint Raphael Campus (SRC) in the first year of the IPP-HPV program or in the one year preceding implementation of the program

OR

* YNHH inpatient postpartum nurses or Women's Center outpatient postpartum nurses or inpatient or outpatient obstetric providers affiliated with the Women's Center or Center for Women's Health and Midwifery
* Able and willing to provide consent

Exclusion Criteria:

-

Primary outcomes:
measure: Count of Eligible Patients Agreeing to Receive a Dose of Vaccine
timeFrame: 12 months
measure: HPV Vaccine Receptivity Thematic Interview
timeFrame: up to 6 weeks postpartum
measure: Barriers to Receiving the HPV Vaccine Thematic Interview
timeFrame: up to 6 weeks postpartum
Secondary outcomes:
measure: Number of Participants Who Received or Did Not Receive a Dose of Vaccine
timeFrame: 12 months postpartum
measure: Receptivity of Healthcare Providers Thematic Interviews
timeFrame: up to 12 months
measure: Concerns of Healthcare Providers Thematic Interview
timeFrame: up to 12 months
Other outcomes:
measure: Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each.
timeFrame: 12 months postpartum
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital, Women's Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Sangini Sheth, MD
role: PRINCIPAL_INVESTIGATOR
References: