Division of General Internal Medicine, Massachusetts General Hospital and Harvard Medical School, Boston.
Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Dartmouth College, Lebanon, New Hampshire.
JAMA. 2023 Oct 10;330(14):1348-1358. doi: 10.1001/jama.2023.18755.
Realizing the benefits of cancer screening requires testing of eligible individuals and processes to ensure follow-up of abnormal results.
To test interventions to improve timely follow-up of overdue abnormal breast, cervical, colorectal, and lung cancer screening results.
DESIGN, SETTING, AND PARTICIPANTS: Pragmatic, cluster randomized clinical trial conducted at 44 primary care practices within 3 health networks in the US enrolling patients with at least 1 abnormal cancer screening test result not yet followed up between August 24, 2020, and December 13, 2021.
Automated algorithms developed using data from electronic health records (EHRs) recommended follow-up actions and times for abnormal screening results. Primary care practices were randomized in a 1:1:1:1 ratio to (1) usual care, (2) EHR reminders, (3) EHR reminders and outreach (a patient letter was sent at week 2 and a phone call at week 4), or (4) EHR reminders, outreach, and navigation (a patient letter was sent at week 2 and a navigator outreach phone call at week 4). Patients, physicians, and practices were unblinded to treatment assignment.
The primary outcome was completion of recommended follow-up within 120 days of study enrollment. The secondary outcomes included completion of recommended follow-up within 240 days of enrollment and completion of recommended follow-up within 120 days and 240 days for specific cancer types and levels of risk.
Among 11 980 patients (median age, 60 years [IQR, 52-69 years]; 64.8% were women; 83.3% were White; and 15.4% were insured through Medicaid) with an abnormal cancer screening test result for colorectal cancer (8245 patients [69%]), cervical cancer (2596 patients [22%]), breast cancer (1005 patients [8%]), or lung cancer (134 patients [1%]) and abnormal test results categorized as low risk (6082 patients [51%]), medium risk (3712 patients [31%]), or high risk (2186 patients [18%]), the adjusted proportion who completed recommended follow-up within 120 days was 31.4% in the EHR reminders, outreach, and navigation group (n = 3455), 31.0% in the EHR reminders and outreach group (n = 2569), 22.7% in the EHR reminders group (n = 3254), and 22.9% in the usual care group (n = 2702) (adjusted absolute difference for comparison of EHR reminders, outreach, and navigation group vs usual care, 8.5% [95% CI, 4.8%-12.0%], P < .001). The secondary outcomes showed similar results for completion of recommended follow-up within 240 days and by subgroups for cancer type and level of risk for the abnormal screening result.
A multilevel primary care intervention that included EHR reminders and patient outreach with or without patient navigation improved timely follow-up of overdue abnormal cancer screening test results for breast, cervical, colorectal, and lung cancer.
ClinicalTrials.gov Identifier: NCT03979495.
实现癌症筛查的益处需要对符合条件的个体进行测试，并确保对异常结果进行后续跟踪。
测试干预措施，以改善逾期的乳腺癌、宫颈癌、结直肠癌和肺癌筛查结果的及时后续跟进。
设计、设置和参与者：在美国 3 个医疗网络中的 44 个初级保健机构进行的实用性、集群随机临床试验，招募了至少有 1 项异常癌症筛查检测结果未得到跟进的患者，这些结果是在 2020 年 8 月 24 日至 2021 年 12 月 13 日之间产生的。
使用电子健康记录（EHR）中的数据开发的自动化算法为异常筛查结果推荐了后续行动和时间。初级保健机构以 1:1:1:1 的比例随机分为（1）常规护理，（2）EHR 提醒，（3）EHR 提醒和外展（在第 2 周发送患者信函，第 4 周进行电话随访），或（4）EHR 提醒、外展和导航（在第 2 周发送患者信函，第 4 周进行导航员外展电话随访）。患者、医生和实践是对治疗分配不知情的。
主要结果是在研究入组后 120 天内完成推荐的随访。次要结果包括在入组后 240 天内完成推荐的随访，以及在 120 天和 240 天内完成特定癌症类型和风险水平的推荐随访。
在 11980 名患有结直肠癌（8245 名患者[69%]）、宫颈癌（2596 名患者[22%]）、乳腺癌（1005 名患者[8%]）或肺癌（134 名患者[1%]）的异常癌症筛查检测结果且异常检测结果被归类为低风险（6082 名患者[51%]）、中风险（3712 名患者[31%]）或高风险（2186 名患者[18%]）的患者中，在接受 EHR 提醒、外展和导航组（n=3455）、EHR 提醒和外展组（n=2569）、EHR 提醒组（n=3254）和常规护理组（n=2702）中，在 120 天内完成推荐随访的比例分别为 31.4%（n=3455）、31.0%（n=2569）、22.7%（n=3254）和 22.9%（n=2702）（EHR 提醒、外展和导航组与常规护理组比较的调整绝对差异为 8.5%[95%CI，4.8%-12.0%]，P<0.001）。次要结果显示，在 240 天内完成推荐随访的比例以及按癌症类型和异常筛查结果风险水平的亚组结果相似。
包括 EHR 提醒和患者外展在内的多层次初级保健干预措施，结合或不结合患者导航，改善了乳腺癌、宫颈癌、结直肠癌和肺癌逾期异常癌症筛查检测结果的及时后续跟进。
ClinicalTrials.gov 标识符：NCT03979495。
