改善老年人结直肠癌筛查适当使用的个性化多层次干预:一项整群随机临床试验。
Personalized Multilevel Intervention for Improving Appropriate Use of Colorectal Cancer Screening in Older Adults: A Cluster Randomized Clinical Trial.
发表日期:2023 Oct 30
作者:
Sameer D Saini, Carmen L Lewis, Eve A Kerr, Brian J Zikmund-Fisher, Sarah T Hawley, Jane H Forman, Ann G Zauber, Iris Lansdorp-Vogelaar, Frank van Hees, Darcy Saffar, Aimee Myers, Lauren E Gauntlett, Rachel Lipson, H Myra Kim, Sandeep Vijan
来源:
JAMA Internal Medicine
摘要:
尽管有指南建议,临床医生并没有系统地使用既往筛查或健康史来指导老年人结直肠癌 (CRC) 筛查决策。 评估个性化多级干预对老年人平均风险 CRC 筛查的筛查顺序的影响。 2015 年 11 月至 2019 年 2 月在美国退伍军人事务部 (VA) 的 2 个机构进行的干预性 2 组平行非掩蔽整群随机临床试验:1 个学术 VA 医疗中心及其 1 个相连的门诊诊所。初级保健医生/临床医生 (PCP) 级别的随机化,按研究地点和临床全职等效人员分层。参与者是 431 名接受初级保健就诊的 70 至 75 岁的平均风险、应筛查的美国退伍军人。数据分析于 2018 年 8 月至 2023 年 8 月进行。干预组接受了多层次干预,包括决策辅助小册子,其中包含有关筛查益处和危害的详细信息,并根据年龄、性别、先前筛查和合并症为每位参与者进行了个性化设置。对照组接受多层次干预,包括筛查信息手册。所有参与者都接受了 PCP 教育和系统级修改以支持个性化筛查。主要结果是是否在就诊后 2 周内下令进行筛查。次要结果是 6 个月内筛查顺序、筛查效益和筛查利用率之间的一致性。共有 436 名患者同意,并对 67 个 PCP 中的 431 名患者进行了分析。患者的平均 (SD) 年龄为 71.5 (1.7) 岁; 424 人为男性(98.4%); 374 人是白人(86.8%);大学毕业生89人(21.5%); 351 人(81.4%)接受过事先筛查。共有 258 人(59.9%)被随机分配至干预组,173 人(40.1%)被随机分配至对照组。对 258 名干预患者中的 162 名 (62.8%) 下达了筛查指令,而对 173 名对照患者中的 114 名 (65.9%) 下达了筛查指令(调整后差异,-4.0 个百分点 [pp];95% CI,-15.4 至 7.4 pp)。在预先指定的交互分析中,对于处于最低效益四分位数的人来说,干预组中收到订单的比例低于对照组(59.4% vs 71.1%)。相比之下,对于最高效益四分位的人来说,干预组收到订单的比例高于对照组(67.6% vs 52.2%)(交互作用 P = .049)。 6 个月时进行总体筛查的干预患者(256 名中的 106 名 [41.4%])少于对照组(173 名中的 96 名 [55.9%])(调整后差异,-13.4 pp;95% CI,-25.3 至 -1.6 pp)。在这项集群随机临床试验中,在多级干预背景下向患者提供有关筛查益处和危害的个性化信息的患者更有可能收到与益处一致的筛查指令,并且不太可能使用筛查。ClinicalTrials.gov 标识符:NCT02027545。
Despite guideline recommendations, clinicians do not systematically use prior screening or health history to guide colorectal cancer (CRC) screening decisions in older adults.To evaluate the effect of a personalized multilevel intervention on screening orders in older adults due for average-risk CRC screening.Interventional 2-group parallel unmasked cluster randomized clinical trial conducted from November 2015 to February 2019 at 2 US Department of Veterans Affairs (VA) facilities: 1 academic VA medical center and 1 of its connected outpatient clinics. Randomization at the primary care physician/clinician (PCP) level, stratified by study site and clinical full-time equivalency. Participants were 431 average-risk, screen-due US veterans aged 70 to 75 years attending a primary care visit. Data analysis was performed from August 2018 to August 2023.The intervention group received a multilevel intervention including a decision-aid booklet with detailed information on screening benefits and harms, personalized for each participant based on age, sex, prior screening, and comorbidity. The control group received a multilevel intervention including a screening informational booklet. All participants received PCP education and system-level modifications to support personalized screening.The primary outcome was whether screening was ordered within 2 weeks of clinic visit. Secondary outcomes were concordance between screening orders and screening benefit and screening utilization within 6 months.A total of 436 patients were consented, and 431 were analyzed across 67 PCPs. Patients had a mean (SD) age of 71.5 (1.7) years; 424 were male (98.4%); 374 were White (86.8%); 89 were college graduates (21.5%); and 351 (81.4%) had undergone prior screening. A total of 258 (59.9%) were randomized to intervention, and 173 (40.1%) to control. Screening orders were placed for 162 of 258 intervention patients (62.8%) vs 114 of 173 control patients (65.9%) (adjusted difference, -4.0 percentage points [pp]; 95% CI, -15.4 to 7.4 pp). In a prespecified interaction analysis, the proportion receiving orders was lower in the intervention group than in the control group for those in the lowest benefit quartile (59.4% vs 71.1%). In contrast, the proportion receiving orders was higher in the intervention group than in the control group for those in the highest benefit quartile (67.6% vs 52.2%) (interaction P = .049). Fewer intervention patients (106 of 256 [41.4%]) utilized screening overall at 6 months than controls (96 of 173 [55.9%]) (adjusted difference, -13.4 pp; 95% CI, -25.3 to -1.6 pp).In this cluster randomized clinical trial, patients who were presented with personalized information about screening benefits and harms in the context of a multilevel intervention were more likely to receive screening orders concordant with benefit and were less likely to utilize screening.ClinicalTrials.gov Identifier: NCT02027545.