Evaluation of the Implementation and Effectiveness of IPP-HPV

Not Applicable

Completed

• Conditions: HPV Vaccination
• Interventions: Drug: HPV vaccine; Behavioral: Inpatient Postpartum HPV Immunization Quality Improvement Program

• Registration Number: NCT02994290
• Lead Sponsor: Yale University

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).

Study Timeline

• Study First Submitted: 2016-12-08
• Study First Submitted QC: 2016-12-12
• Study First Posted: 2016-12-15
• Study Start: 2017-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Results First Submitted: 2022-10-31
• Status Verified: 2022-12
• Results First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Results First Posted: 2023-01-09
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 817

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
receive inpatient HPV vaccine	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.
receive inpatient HPV vaccine	Inpatient Postpartum HPV Immunization Quality Improvement Program	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.
decline the inpatient dose	Inpatient Postpartum HPV Immunization Quality Improvement Program	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.

Primary Outcome Measures

Name	Time	Method
Count of Eligible Patients Agreeing to Receive a Dose of Vaccine	12 months	Data gathered via medical charts for which participants agreed to receive a dose and which did not
HPV Vaccine Receptivity Thematic Interview	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	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 Outcome Measures

Name	Time	Method
Number of Participants Who Received or Did Not Receive a Dose of Vaccine	12 months postpartum	Data gathered via medical charts for which participants received vaccine as inpatient and which did not.
Receptivity of Healthcare Providers Thematic Interviews	up to 12 months	The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.
Concerns of Healthcare Providers Thematic Interview	up to 12 months	The in-depth individual interviews will be conducted using a semistructured guide based on Consolidated Framework for Implementation Research (CFIR) constructs. Recorded interviews will be transcribed and transcripts analyzed using standard analytic methods for qualitative data as described above. Provider receptivity of IPP-HPV and perceptions of patient acceptance will be categorized by themes. This outcome reflects the number of themes derived from thematic interviews.

Trial Locations

Locations (1)

Yale New Haven Hospital, Women's Center; 🇺🇸 New Haven, Connecticut, United States