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Clinical Trials/NCT02994290
NCT02994290
Completed
Not Applicable

Evaluation of the Implementation and Effectiveness of a Pilot Quality Improvement Program to Increase HPV Vaccine Uptake: Inpatient Postpartum HPV Immunization (IPP-HPV) Program

Yale University1 site in 1 country817 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
HPV vaccine
Conditions
HPV Vaccination
Sponsor
Yale University
Enrollment
817
Locations
1
Primary Endpoint
Count of Eligible Patients Agreeing to Receive a Dose of Vaccine
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
October 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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
  • 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
  • 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

Exclusion Criteria

  • Not provided

Arms & Interventions

receive inpatient HPV vaccine

We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.

Intervention: HPV vaccine

receive inpatient HPV vaccine

We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.

Intervention: Inpatient Postpartum HPV Immunization Quality Improvement Program

decline the inpatient dose

We will select a purposive sample of postpartum women into two groups: those who receive inpatient HPV vaccine and those who decline the inpatient dose to interview until we reach thematic saturation which we anticipate to occur with about 8-10 individuals per group. Patients will be selected to include diverse representation in age, race, ethnicity, and parity.

Intervention: Inpatient Postpartum HPV Immunization Quality Improvement Program

Outcomes

Primary Outcomes

Count of Eligible Patients Agreeing to Receive a Dose of Vaccine

Time Frame: 12 months

Data gathered via medical charts for which participants agreed to receive a dose and which did not

HPV Vaccine Receptivity Thematic Interview

Time Frame: up to 6 weeks postpartum

In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.

Barriers to Receiving the HPV Vaccine Thematic Interview

Time Frame: up to 6 weeks postpartum

In-person, in-depth interviews will be conducted prior to discharge home from the postpartum hospitalization. If an in-person interview prior to discharge is not possible, an in-person interview will be conducted at the 6-week postpartum visit. Interviews will be conducted using a semi-structured guide with questions based on Consolidated Framework for Implementation Research (CFIR) constructs. Transcripts will be analyzed to determine common themes and priority domains. Standard analytic methods for qualitative data will be employed. A codebook will be developed based on deductive (theory-driven) constructs from the interview guide and applied to a subset of transcripts. This outcome reflects the number of themes derived from thematic interviews.

Secondary Outcomes

  • Number of Participants Who Received or Did Not Receive a Dose of Vaccine(12 months postpartum)
  • Receptivity of Healthcare Providers Thematic Interviews(up to 12 months)
  • Concerns of Healthcare Providers Thematic Interview(up to 12 months)

Study Sites (1)

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