PCOM2 - The Physician Communication Intervention, Version 2.0

PCOM2 - 医生沟通干预，版本 2.0

• 批准号: 10367487
• 负责人: Sean T O'Leary
• 金额: $ 58.62万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-15 至 2026-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10367487
• 关键词: 12 year old; Address; Adolescent; Affect; Age; Anogenital cancer; Anogenital venereal warts; Cervical; Characteristics; Clinical; Cluster randomized trial; Communication; Cost Analysis; Custom; Data; Disease; E-learning; Educational process of instructing; Ensure; Failure; Fostering; Geography; Goals; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papilloma virus infection; Infection prevention; Intervention; Kansas; Lead; Libraries; Link; Locales; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Manuals; Methods; Motivation; Pap smear; Parents; Patients; Physicians; Population; Practical Robust Implementation and Sustainability Model; Primary Health Care; Process; Provider; Public Health; Randomized; Randomized Clinical Trials; Recommendation; Reporting; Research; Risk; Rural; Series; Services; Sexually Transmitted Diseases; Techniques; Testing; Trainers Training; Training; Translating; Treatment Efficacy; Vaccinated; Vaccination; Vaccines; Vagina; Virus; Work; care providers; comparative effectiveness trial; comparative efficacy; contextual factors; dissemination science; implementation science; improved; malignant oropharynx neoplasm; motivational enhancement therapy; patient population; penis; prevent; prototype; recruit; vaccine acceptance; vaccine hesitancy; virtual; virtual intervention

PROJECT SUMMARY/ABSTRACT Human Papillomaviruses (HPV) infect >90% of the population and cause >30,000 cervical, anogenital, and oropharyngeal cancers annually. HPV vaccines have been available in the US since 2006 but only 54% of 11- 12 years-olds are vaccinated - well below national goals of 80%. As the title of the PAR to which this applica- tion responds suggests (PAR-19-360), “Linking the Provider Recommendation to Adolescent HPV Vaccine Up- take” is a key strategy for increasing adolescent HPV vaccination. Many studies show that a primary driver of low adolescent HPV vaccination is a poor quality HPV vaccine recommendation from providers. While many interventions to address this have been developed, few have been found in rigorous trials to increase vaccina- tion and also be feasible to implement in busy clinical settings. An exception is the Physician Communication, or PCOM, intervention developed by our group. PCOM focuses on teaching providers to use a 2-step verbal communication process for their recommendation:1) start the vaccine discussion using a “presumptive” format (i.e. “Let's get the HPV vaccine done today”) and 2) use motivational interviewing (MI) techniques to address parental vaccine hesitancy, if needed. In a large, cluster-randomized trial, PCOM increased adolescent HPV vaccine initiation rates among 11-12 year olds by 8 percentage points (PP) more than controls– a relatively large effect size for a vaccination intervention. Limiting broad dissemination of PCOM is the significant level of research team facilitation needed to teach practices how to use the PCOM components. To address this, we propose to develop a “Virtual” version of the PCOM intervention (“PCOM-Virtual”) and test it for non-inferiority to the original PCOM intervention (“PCOM-Standard”) for increasing adolescent HPV vaccination. By using Dissemination & Implementation (D&I) science principles throughout the process and collecting information on how contextual practice, provider and patient factors influence PCOM use, we anticipate creating a “shelf ready” version of PCOM with an associated “User Manual” to foster dissemination. Our Aims are to: 1. Develop the “PCOM-Virtual” intervention using principles of D&I Science from existing prototypes. 2. Compare the efficacy of “PCOM-Virtual” vs. “PCOM-Standard” in improving adolescent HPV vac- cine utilization. A cluster-randomized non-inferiority trial will be conducted in 30 primary care practices in Kansas – a locale with some of the lowest adolescent HPV vaccination rates nationally. 3. Examine whether practice, patient and provider characteristics are associated with variability in the efficacy of PCOM-Virtual and PCOM-Standard. Mixed methods and the PRISM framework will facili- tate understanding how context influences the interventions' implementation to inform a User Manual. By creating an easily implementable version of the PCOM intervention, and disseminating it widely we believe we can have a substantial impact on adolescent HPV vaccination levels.

项目总结/摘要 人乳头瘤病毒（HPV）感染>90%的人群，并导致> 30，000例宫颈、肛门生殖器和生殖器感染。 每年都有癌症。自2006年以来，HPV疫苗已在美国上市，但只有54%的11- 12岁儿童接种疫苗-远低于80%的国家目标。作为本申请适用的PAR的标题- Tion回应建议（PAR-19-360），“将提供者建议与青少年HPV疫苗联系起来- “接种”是增加青少年HPV疫苗接种的关键策略。许多研究表明， 低青少年HPV疫苗接种是提供者推荐的低质量HPV疫苗。虽然许多 已经开发了解决这一问题的干预措施，但在严格的试验中发现很少有增加疫苗接种的措施， 并且在忙碌的临床环境中也是可行的。一个例外是医生沟通， 或者叫PCOM，是我们小组开发的干预手段PCOM专注于教导供应商使用两步口头 他们建议的沟通过程：1）使用“假定”格式开始疫苗讨论 (i.e.“让我们今天就接种HPV疫苗”）和2）使用动机性访谈（MI）技术来解决 如果需要，父母疫苗犹豫。在一项大型随机分组试验中，PCOM增加了青少年HPV 11-12岁儿童的疫苗启动率比对照组高8个百分点（PP）-相对而言， 疫苗接种干预的大效应量。限制PCOM广泛传播的重要因素是 研究团队的促进需要教实践如何使用PCOM组件。为了解决这个问题，我们 建议开发PCOM干预的“虚拟”版本（“PCOM-Virtual”），并测试其非劣效性 最初的PCOM干预措施（“PCOM标准”），以增加青少年HPV疫苗接种。通过使用 在整个过程中传播和实施（D&I）科学原则，并收集以下方面的信息 背景实践、提供者和患者因素如何影响PCOM的使用，我们预计将创建一个“架子 （c）编制一个“准备就绪”的PCOM版本，并附有相关的“用户手册”，以促进传播。我们的目标是： 1.利用现有原型的D&I科学原理开发“PCOM虚拟”干预。 2.比较“PCOM-Virtual”与“PCOM-Standard”在改善青少年HPV疫苗接种方面的疗效- 电影利用率一项随机分组的非劣效性试验将在30个初级保健实践中进行， 堪萨斯--一个全国青少年HPV疫苗接种率最低的地区。 3.检查实践、患者和提供者特征是否与 PCOM虚拟和PCOM标准的有效性。混合方法和PRISM框架将促进- 了解背景如何影响干预措施的实施，以告知用户手册。 通过创建一个易于实施的PCOM干预版本，并广泛传播，我们相信， 我们可以对青少年HPV疫苗接种水平产生重大影响。