De-Implementation of Low-Value Cervical Cancer Screening

低价值宫颈癌筛查的取消

• 批准号: 10523218
• 负责人: Katharine A. Rendle
• 金额: $ 37.17万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10523218
• 关键词: Address; Age; Appointment; Awareness; Behavior; Behavioral; Belief; COVID-19 pandemic; Cancer Center; Cancer Control; Caring; Cervical; Cervical Cancer Screening; Clinic; Clinical; Complex; Consensus; Consolidated Framework for Implementation Research; Data; Deimplementation; Diagnostic Procedure; Effectiveness; Electronic Health Record; Ensure; Equilibrium; Evaluation; Failure; Female; Financial cost; Guideline Adherence; Guidelines; Gynecology; Health system; Healthcare Systems; Heterogeneity; High grade dysplasia; Hybrids; Information Technology; Interview; Knowledge; Laboratories; Lead; Malignant neoplasm of cervix uteri; Measurement; Measures; Medical; Methods; Modeling; Motivation; National Cancer Institute; Outcome; Pathway interactions; Patients; Population Heterogeneity; Primary Health Care; Public Health; Publishing; Race; Randomized Controlled Trials; Recording of previous events; Reporting; Research Design; Risk; Sampling; Scientist; Shapes; Stimulus; Surveys; Testing; Theoretical model; Touch sensation; Translating; United States; Work; age group; aged; base; clinical care; cohort; contextual factors; cost; design; effectiveness testing; evidence based guidelines; implementation cost; implementation outcomes; implementation science; implementation strategy; implementation trial; innovation; medical specialties; opportunity cost; organizational climate; patient-clinician communication; point of care; psychosocial; routine care; screening; sex; success; theories; treatment as usual; unnecessary treatment

Modified Project Summary/Abstract Section PROJECT SUMMARY Up to 45% of all cervical cancer screening in the United States is considered to be overuse, despite consensus guidelines and strong evidence of the limited benefit and potential harm of low-value screening. Overscreening for cervical cancer includes screening more frequently than is recommended or outside the recommended age groups. Overscreening can lead to increased false positives and psychosocial harms, cause unnecessary treatment of cervical abnormalities that would likely resolve on their own, and result in excess financial and opportunity costs. While there are several implementation strategies shown to be effective for increasing cervical cancer screening, it is largely unknown how best to decrease overscreening in routine care. As such, there is a critical need to develop effective strategies for ensuring de-implementation of outdated screening practices. To help fill this gap, this study will 1) test the independent and combined effects of patient- and clinician-directed de-implementation strategies on rates of cervical cancer overscreening in comparison to usual care, and 2) evaluate contextual mechanisms contributing to the success or failure of each de-implementation strategy using coincidence analysis. To achieve these aims, a 2x2 randomized controlled trial with approximately 200 clinicians and 2,400 patients will be conducted in primary care and gynecology clinics affiliated with a large healthcare system with high rates of cervical cancer overscreening. The highly efficient factorial and pragmatic design will enable assessment of independent and combined effects of each strategy. Drawing from systematic evidence of the effectiveness of nudge strategies to increase guideline adherence and an integrated theoretical model, the specific de-implementation strategies to be tested are: 1) theory-based messaging shown to be effective at decreasing overscreening intentions (patient nudge strategy); and 2) point of care reminders alerting clinicians if patients are not due for screening (clinician nudge strategy). The primary de-implementation outcome is reduction in the rate of cervical cancer overscreening among females who are not due for screening based on evidence-based guidelines. Secondary de-implementation outcomes, including reach, acceptability, and feasibility, and implementation costs, and clinical outcomes including rate of abnormal results, false-positives, and diagnostic procedures will also be measured. Following the trial, a stratified, embedded cohort of patients and clinicians will be surveyed and interviewed to evaluate contextual factors contributing to the success or failure of each strategy using coincidence analysis. This innovative project responds directly to the call by the National Cancer Institute to develop and test de-implementation strategies in cancer control. Further, the proposed low-touch strategies are designed to support widespread and equitable implementation across diverse settings, and, if successful, be translated to address other forms of overuse across primary and specialty care. This work will also help to broadly advance causal theory in de-implementation science by evaluating underlying contextual mechanisms that contribute to the effectiveness of strategies among diverse populations.

修改后的项目摘要/摘要部分 项目概要 尽管有共识指南和强有力的证据表明低价值筛查的益处有限且存在潜在危害，但在美国，高达 45% 的宫颈癌筛查被认为是过度使用。宫颈癌过度筛查包括筛查频率高于建议的频率或超出建议的年龄组。过度筛查可能会导致误报和社会心理伤害增加，导致对可能自行解决的宫颈异常进行不必要的治疗，并导致过多的财务和机会成本。虽然有几种实施策略被证明可有效增加宫颈癌筛查，但如何最好地减少常规护理中的过度筛查尚不清楚。因此，迫切需要制定有效的策略来确保取消过时的筛查做法。为了帮助填补这一空白，本研究将 1) 测试患者和临床医生指导的取消实施策略与常规护理相比对宫颈癌过度筛查率的独立和综合影响，2) 评估有助于成功的背景机制使用巧合分析来确定每个取消实施策略的失败。为了实现这些目标，一项由约 200 名临床医生和 2,400 名患者参加的 2x2 随机对照试验将在隶属于宫颈癌过度筛查率较高的大型医疗保健系统的初级保健和妇科诊所进行。高效的因子和实用设计将能够评估每个策略的独立和综合效果。根据推动策略有效性的系统证据和综合理论模型，要测试的具体取消实施策略是：1）基于理论的消息传递被证明可有效减少过度筛选意图（患者推动策略） ; 2) 如果患者未到筛查时间，护理点提醒会提醒临床医生（临床医生推动策略）。取消实施的主要结果是降低了根据循证指南不应进行筛查的女性中宫颈癌过度筛查率。还将衡量二次取消实施结果，包括范围、可接受性和可行性以及实施成本，以及临床结果，包括异常结果率、假阳性和诊断程序。试验结束后，将对分层的患者和临床医生进行调查和访谈，以使用巧合分析来评估导致每种策略成功或失败的背景因素。这个创新项目直接响应国家癌症研究所的号召，制定和测试癌症控制的取消实施策略。此外，拟议的低接触策略旨在支持在不同环境中广泛和公平地实施，如果成功，可以转化为解决初级和专科护理中其他形式的过度使用。这项工作还将通过评估有助于不同人群中策略有效性的潜在背景机制，有助于广泛推进去执行科学中的因果理论。