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| ID | Type | Description | Link |
|---|---|---|---|
| 1K07CA230234-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| receive inpatient HPV vaccine | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV vaccine | Drug | After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Eligible Patients Agreeing to Receive a Dose of Vaccine | Data gathered via medical charts for which participants agreed to receive a dose and which did not | 12 months |
| HPV Vaccine Receptivity Thematic Interview | 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. | up to 6 weeks postpartum |
| Barriers to Receiving the HPV Vaccine Thematic Interview | 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. | up to 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received or Did Not Receive a Dose of Vaccine | Data gathered via medical charts for which participants received vaccine as inpatient and which did not. | 12 months postpartum |
| Receptivity of Healthcare Providers Thematic Interviews |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each. | Data gathered via medical charts | 12 months postpartum |
Inclusion Criteria:
AND
OR
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Sangini Sheth, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital, Women's Center | New Haven | Connecticut | 06520 | United States |
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787 participants and 30 providers
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| ID | Title | Description |
|---|---|---|
| FG000 | Receive Inpatient HPV Vaccine | The investigators 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. HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews. Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses. Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed. |
| FG001 | Decline the Inpatient Dose | The investigators 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. HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews. Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses. Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed. |
| FG002 | Providers | Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
787 total eligible participants and 30 providers
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| ID | Title | Description |
|---|---|---|
| BG000 | Receive Inpatient HPV Vaccine | The investigators 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 a thematic saturation is reached. Patients will be selected to include diverse representation in age, race, ethnicity, and parity. HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews. Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses. Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | mean age in years at delivery |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Eligible Patients Agreeing to Receive a Dose of Vaccine | Data gathered via medical charts for which participants agreed to receive a dose and which did not | 787 total eligible participants | Posted | Number | participants | 12 months |
|
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Adverse events were not tracked as it was not part of the study protocol
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eligible to 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. HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews. Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses. Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sangini Sheth | Yale University | 203-785-5545 | Sangini.Sheth@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2019 | Oct 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Inpatient Postpartum HPV Immunization Quality Improvement Program | Behavioral | The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses. Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed. |
|
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. |
| up to 12 months |
| Concerns of Healthcare Providers Thematic Interview | 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. | up to 12 months |
| BG001 | Decline the Inpatient Dose | The investigators 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 a thematic saturation is reached. Patients will be selected to include diverse representation in age, race, ethnicity, and parity. HPV vaccine: After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews. Inpatient Postpartum HPV Immunization Quality Improvement Program: The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses. Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed. |
| BG002 | Providers | Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women. All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed. |
| BG003 | Total | Total of all reporting groups |
this is for patient participants
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | this data was only collected for providers | Count of Participants | Participants |
|
| Sex: Female, Male | only post-partum women were eligible, data was not collected for providers | was not collected for providers | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 787 participants and 30 providers | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Preferred Language | data was not collected for providers | this data was only collected for participants | Count of Participants | Participants |
|
| Providers Job Title | data was only collected for providers | this data was only collected for providers | Count of Participants | Participants |
|
|
|
| Primary | HPV Vaccine Receptivity Thematic Interview | 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. | a random sub sample of overall participants that completed the thematic interview | Posted | Number | themes | up to 6 weeks postpartum |
|
|
|
| Primary | Barriers to Receiving the HPV Vaccine Thematic Interview | 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. | a random sub sample of participants that completed the thematic interview | Posted | Number | themes | up to 6 weeks postpartum |
|
|
|
| Secondary | Number of Participants Who Received or Did Not Receive a Dose of Vaccine | Data gathered via medical charts for which participants received vaccine as inpatient and which did not. | 787 total eligible participants | Posted | Number | participants | 12 months postpartum |
|
|
|
| Secondary | Receptivity of Healthcare Providers Thematic Interviews | 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. | 30 providers | Posted | Number | themes | up to 12 months |
|
|
|
| Secondary | Concerns of Healthcare Providers Thematic Interview | 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. | 30 providers | Posted | Number | themes | up to 12 months |
|
|
|
| Other Pre-specified | Proportion of Patients Who Are Due for Tdap, Influenza or MMR Vaccines and Received Each. | Data gathered via medical charts | data was not collected for this outcome | Posted | 12 months postpartum |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| 41-60 |
|
| 61+ |
|
| Did not report |
|
| Male |
|
| White |
|
| Hispanic |
|
| Other |
|
| Unknown |
|
| Asian |
|
| Spanish |
|
| Other |
|
| Unknown |
|
| Certified Nurse-Midwife |
|
| Physician |
|
| Physician Assistant |
|
| Advanced Practice Registered Nurse |
|