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Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial
BACKGROUND: Each year, human papillomavirus (HPV) causes 30,000 cancers in the USA despite the availability of effective and safe vaccines. Uptake of HPV vaccine has been low and lags behind other adolescent vaccines. This protocol describes a multilevel intervention to improve HPV vaccination rates...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6043954/ https://www.ncbi.nlm.nih.gov/pubmed/30001723 http://dx.doi.org/10.1186/s13012-018-0778-x |
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author | Finney Rutten, Lila J. Radecki Breitkopf, Carmen St. Sauver, Jennifer L. Croghan, Ivana T. Jacobson, Debra J. Wilson, Patrick M. Herrin, Jeph Jacobson, Robert M. |
author_facet | Finney Rutten, Lila J. Radecki Breitkopf, Carmen St. Sauver, Jennifer L. Croghan, Ivana T. Jacobson, Debra J. Wilson, Patrick M. Herrin, Jeph Jacobson, Robert M. |
author_sort | Finney Rutten, Lila J. |
collection | PubMed |
description | BACKGROUND: Each year, human papillomavirus (HPV) causes 30,000 cancers in the USA despite the availability of effective and safe vaccines. Uptake of HPV vaccine has been low and lags behind other adolescent vaccines. This protocol describes a multilevel intervention to improve HPV vaccination rates. METHODS: Using a cluster randomized trial, we will evaluate the independent and combined impact of two evidence-based implementation strategies with innovative enhancements on HPV vaccination rates for female and male patients. The clusters are six primary care sites providing care to pediatric populations. We will use a stepped-wedge cluster randomized design, including process evaluation, to test the hypothesis that compared with the current course of care and a practice-level intervention using reminder-recall interventions coupled with provider-level audit and feedback with education increases HPV vaccination rates in exposed clusters. The factorial design allows us to use a single trial to test these two interventions and to assess each individually and in combination. Our design has four 12-month steps. The first step will be a baseline period; data collected during it will provide a within-practice control group for each cluster. Second, two clusters will be randomly assigned to receive intervention 1 (reminder and recall), and two clusters will be randomly selected to receive intervention 2 (audit and feedback with education). Third, the other two clusters will be randomly allocated to intervention 1 or 2. Clusters initially with intervention 1 will be randomly allocated to 1 + 2 or 1; clusters initially with intervention 2 will be randomly allocated to 1 + 2 or 2. Fourth, all clusters will receive both interventions. To ensure balance of patient numbers across interventions, we will use block randomization at the first step, with the six clusters grouped into three pairs according to volume. Our primary outcome will be vaccination rates. DISCUSSION: Results of our clinical trial and process evaluation will provide evidence showing whether practice- and provider-level interventions improve HPV vaccination rates and will offer insight into contextual factors associated with direction and magnitude of trial outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03501992, registered April 18, 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13012-018-0778-x) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6043954 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-60439542018-07-13 Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial Finney Rutten, Lila J. Radecki Breitkopf, Carmen St. Sauver, Jennifer L. Croghan, Ivana T. Jacobson, Debra J. Wilson, Patrick M. Herrin, Jeph Jacobson, Robert M. Implement Sci Study Protocol BACKGROUND: Each year, human papillomavirus (HPV) causes 30,000 cancers in the USA despite the availability of effective and safe vaccines. Uptake of HPV vaccine has been low and lags behind other adolescent vaccines. This protocol describes a multilevel intervention to improve HPV vaccination rates. METHODS: Using a cluster randomized trial, we will evaluate the independent and combined impact of two evidence-based implementation strategies with innovative enhancements on HPV vaccination rates for female and male patients. The clusters are six primary care sites providing care to pediatric populations. We will use a stepped-wedge cluster randomized design, including process evaluation, to test the hypothesis that compared with the current course of care and a practice-level intervention using reminder-recall interventions coupled with provider-level audit and feedback with education increases HPV vaccination rates in exposed clusters. The factorial design allows us to use a single trial to test these two interventions and to assess each individually and in combination. Our design has four 12-month steps. The first step will be a baseline period; data collected during it will provide a within-practice control group for each cluster. Second, two clusters will be randomly assigned to receive intervention 1 (reminder and recall), and two clusters will be randomly selected to receive intervention 2 (audit and feedback with education). Third, the other two clusters will be randomly allocated to intervention 1 or 2. Clusters initially with intervention 1 will be randomly allocated to 1 + 2 or 1; clusters initially with intervention 2 will be randomly allocated to 1 + 2 or 2. Fourth, all clusters will receive both interventions. To ensure balance of patient numbers across interventions, we will use block randomization at the first step, with the six clusters grouped into three pairs according to volume. Our primary outcome will be vaccination rates. DISCUSSION: Results of our clinical trial and process evaluation will provide evidence showing whether practice- and provider-level interventions improve HPV vaccination rates and will offer insight into contextual factors associated with direction and magnitude of trial outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03501992, registered April 18, 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13012-018-0778-x) contains supplementary material, which is available to authorized users. BioMed Central 2018-07-13 /pmc/articles/PMC6043954/ /pubmed/30001723 http://dx.doi.org/10.1186/s13012-018-0778-x Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Finney Rutten, Lila J. Radecki Breitkopf, Carmen St. Sauver, Jennifer L. Croghan, Ivana T. Jacobson, Debra J. Wilson, Patrick M. Herrin, Jeph Jacobson, Robert M. Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial |
title | Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial |
title_full | Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial |
title_fullStr | Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial |
title_full_unstemmed | Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial |
title_short | Evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial |
title_sort | evaluating the impact of multilevel evidence-based implementation strategies to enhance provider recommendation on human papillomavirus vaccination rates among an empaneled primary care patient population: a study protocol for a stepped-wedge cluster randomized trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6043954/ https://www.ncbi.nlm.nih.gov/pubmed/30001723 http://dx.doi.org/10.1186/s13012-018-0778-x |
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