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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01225 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P01CA229143 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well a multi-level health system-based intervention works in improving human papillomavirus (HPV) vaccine initiation and completion among children in health systems in four Appalachian states. Utilizing educational and promotional materials and electronic health record reminders, may improve the uptake of the HPV vaccine in children and young adults, ultimately preventing the development of cervical cancer.
PRIMARY OBJECTIVE:
I. Test the effectiveness of a multi-level intervention (MLI) directed at clinics, providers, and patients (parents of children aged 11-12) to improve HPV vaccine initiation and completion in health systems in four Appalachian states (Kentucky [KY], Ohio [OH], West Virginia [WV,] and Virginia [VA]) among children aged 11-12 and assess the effectiveness of the intervention program among subgroups, e.g., females versus (vs) males.
SECONDARY OBJECTIVES:
I. Assess sustainability of the intervention. II. Assess cost impacts of the intervention III. Assess changes in clinic practices that occur as a result of the intervention in terms of staff responsibilities for the vaccination process and reducing missed opportunities for vaccination.
IV. Assess whether interventions focused on 13-26 year olds increases catch-up vaccination.
V. Examine changes in knowledge and attitudes of providers via educational session pre-post surveys.
VI. Satisfaction with the intervention at the multiple levels.
OUTLINE: Health systems are randomized to 1 of 2 arms.
ARM I (EARLY INTERVENTION): Health systems receive educational materials consisting of posters, brochures and table tents. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination.
ARM II (DELAYED INTERVENTION): Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM I (EARLY INTERVENTION) (educational material, reminders) | Experimental | Health systems receive educational materials consisting of posters, brochures and handouts. Providers complete survey about HPV knowledge, participate in educational session over 1 hour and receive educational handouts on the HPV vaccine. Patients receive educational materials about HPV vaccine and reminder letters for HPV vaccination |
|
| ARM II (DELAYED INTERVENTION)(education, reminder, usual care) | Experimental | Health systems, providers, and patients receive usual care for 12 months, then receive multi-level intervention as in Arm I. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in rate of human papillomavirus (HPV) vaccination initiation among 11-12 year olds | The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics. | Baseline up to 24 months |
| Change in rate of HPV vaccination initiation among those 13-26 | The effectiveness of the intervention will be assessed by comparing early vs delayed intervention clinics at the end of the first implementation phase adjusting for baseline rates and pre- versus (vs) post implementation rates in the delayed implementation clinics. | Baseline up to 24 months |
| Sustainability | Will use logistic regression models with random health systems effects to compare odds of vaccination at the end of sustainability period to odds of vaccination at the end of the implementation period. | Up to 24 months |
| Cost-effectiveness | Will conduct the cost-effectiveness analyses of using the multi-level intervention (MLI) intervention to promote HPV vaccination in three broad steps. | Up to 60 months |
| Change in knowledge of providers | Will compare changes in knowledge of providers via educational session pre-post survey. Changes in Knowledge following the educational session will be assessed using linear mixed models containing random health system effects. | Baseline up to 60 months |
| Change in attitudes of providers |
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Inclusion Criteria:
CLINIC
HEALTH CARE PROVIDERS (PHYSICIANS, NURSES) AND OFFICE STAFF
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| Name | Affiliation | Role |
|---|---|---|
| Electra D Paskett | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States | ||
| Ohio State University Comprehensive Cancer Center |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Educational Intervention | Other | Receive educational materials |
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| Questionnaire Administration | Other | Ancillary studies |
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| Reminder | Other | Receive reminder letter |
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Will compare changes in attitudes of providers via educational session pre-post survey.
| Baseline up to 60 months |
| Columbus |
| Ohio |
| 43210 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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