De-Implementation of Low-Value Cervical Cancer Screening

低价值宫颈癌筛查的取消

• 批准号: 10675074
• 负责人: Katharine A. Rendle
• 金额: $ 36.43万
• 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/10675074
• 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; Equity; Evaluation; Failure; Female; Financial cost; Guideline Adherence; Guidelines; Gynecology; Health system; Healthcare Systems; Heterogeneity; High grade dysplasia; Hybrids; Information Technology; Interview; Knowledge; Laboratories; Malignant neoplasm of cervix uteri; Measurement; Measures; Medical; Methods; Modeling; Motivation; National Cancer Institute; Outcome; Pathway interactions; Patients; Population Heterogeneity; Primary Care; Public Health; Publishing; Race; Randomized, Controlled Trials; Recommendation; 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; 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 项目总结 在美国，高达45%的宫颈癌筛查被认为是过度使用的，尽管普遍的指导方针和强有力的证据表明，低价值筛查的益处和潜在危害有限。宫颈癌的过度筛查包括比推荐的年龄组更频繁的筛查或超出推荐的年龄组。过度筛查可能会导致假阳性和心理社会伤害的增加，导致对宫颈异常的不必要治疗，这些疾病很可能会自行解决，并导致过高的经济和机会成本。虽然有几种实施策略被证明对增加宫颈癌筛查是有效的，但如何最好地减少常规护理中的过度筛查在很大程度上是未知的。因此，迫切需要制定有效的战略，确保淘汰过时的筛查做法。为了帮助填补这一空白，这项研究将1)测试患者和临床医生指导的去实施策略与常规护理相比对宫颈癌过度筛查比率的独立和联合影响，以及2)使用符合分析来评估每种去实施策略成功或失败的背景机制。为了实现这些目标，一项有大约200名临床医生和2400名患者参加的2x2随机对照试验将在附属于一个宫颈癌过度筛查比率较高的大型保健系统的初级保健和妇科诊所进行。高效的因素设计和实用设计将使评估每个战略的独立和综合影响成为可能。根据系统证据和一个完整的理论模型，需要测试的具体去实施策略是：1)基于理论的消息传递被证明在减少过度筛查意图方面是有效的(患者轻推策略)；以及2)如果患者不应进行筛查，护理点提醒提醒临床医生(临床医生轻推策略)。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的比率。二次取消实施的结果，包括可及性、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、假阳性和诊断程序的比率，也将被衡量。试验结束后，将对分层、嵌入的患者和临床医生队列进行调查和采访，以使用符合分析来评估影响每种策略成败的背景因素。这一创新项目直接响应了国家癌症研究所的号召，即制定和测试癌症控制方面的非执行战略。此外，拟议的低接触战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保健和专科护理中其他形式的过度使用问题。这项工作还将有助于通过评估有助于战略在不同人群中的有效性的潜在背景机制，在去执行科学中广泛推进因果理论。