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一项家庭健康史平台的群组随机试验,旨在识别和管理结直肠癌风险增加的患者。

A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer.

机构信息

William S. Middleton Memorial Veterans Hospital, Madison, WI, USA.

Department of Surgery, University of Wisconsin-Madison, Madison, WI, USA.

出版信息

J Gen Intern Med. 2023 May;38(6):1375-1383. doi: 10.1007/s11606-022-07787-9. Epub 2022 Oct 28.

DOI:10.1007/s11606-022-07787-9
PMID:36307642
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10160317/
Abstract

BACKGROUND

Obtaining comprehensive family health history (FHH) to inform colorectal cancer (CRC) risk management in primary care settings is challenging.

OBJECTIVE

To examine the effectiveness of a patient-facing FHH platform to identify and manage patients at increased CRC risk.

DESIGN

Two-site, two-arm, cluster-randomized, implementation-effectiveness trial with primary care providers (PCPs) randomized to immediate intervention versus wait-list control.

PARTICIPANTS

PCPs treating patients at least one half-day per week; patients aged 40-64 with no medical conditions that increased CRC risk.

INTERVENTIONS

Immediate-arm patients entered their FHH into a web-based platform that provided risk assessment and guideline-driven decision support; wait-list control patients did so 12 months later.

MAIN MEASURES

McNemar's test examined differences between the platform and electronic medical record (EMR) in rates of increased risk documentation. General estimating equations using logistic regression models compared arms in risk-concordant provider actions and patient screening test completion. Referral for genetic consultation was analyzed descriptively.

KEY RESULTS

Seventeen PCPs were randomized to each arm. Patients (n = 252 immediate, n = 253 control) averaged 51.4 (SD = 7.2) years, with 83% assigned male at birth, 58% White persons, and 33% Black persons. The percentage of patients identified as increased risk for CRC was greater with the platform (9.9%) versus EMR (5.2%), difference = 4.8% (95% CI: 2.6%, 6.9%), p < .0001. There was no difference in PCP risk-concordant action [odds ratio (OR) = 0.7, 95% CI (0.4, 1.2; p = 0.16)]. Among 177 patients with a risk-concordant screening test ordered, there was no difference in test completion, OR = 0.8 [0.5,1.3]; p = 0.36. Of 50 patients identified by the platform as increased risk, 78.6% immediate and 68.2% control patients received a recommendation for genetic consultation, of which only one in each arm had a referral placed.

CONCLUSIONS

FHH tools could accurately assess and document the clinical needs of patients at increased risk for CRC. Barriers to acting on those recommendations warrant further exploration.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov NCT02247336 https://clinicaltrials.gov/ct2/show/NCT02247336.

摘要

背景

在初级保健环境中获取全面的家族健康史(FHH)以告知结直肠癌(CRC)风险管理具有挑战性。

目的

研究一种面向患者的 FHH 平台,以识别和管理 CRC 风险增加的患者。

设计

在具有初级保健提供者(PCP)的两个地点、两个臂、集群随机、实施有效性试验中,将 PCP 随机分配至立即干预组或候补名单对照组。

参与者

每周至少治疗一半天患者的 PCP;年龄在 40-64 岁之间、无增加 CRC 风险的医疗条件的患者。

干预措施

立即干预组的患者将其 FHH 输入到一个基于网络的平台,该平台提供风险评估和基于指南的决策支持;候补名单对照组的患者在 12 个月后进行。

主要措施

麦克内马尔检验比较了平台和电子病历(EMR)在增加风险记录率方面的差异。使用逻辑回归模型的一般估计方程比较了手臂之间在风险一致的提供者操作和患者筛查测试完成方面的差异。遗传咨询的转介进行了描述性分析。

主要结果

17 名 PCP 被随机分配到每个臂。患者(n = 252 例立即组,n = 253 例对照组)的平均年龄为 51.4(SD = 7.2)岁,其中 83%为出生时的男性,58%为白人,33%为黑人。通过平台(9.9%)确定为 CRC 风险增加的患者比例高于 EMR(5.2%),差异= 4.8%(95%CI:2.6%,6.9%),p<.0001。在 PCP 风险一致的行动方面没有差异[优势比(OR)=0.7,95%CI(0.4,1.2;p=0.16)]。在 177 名有风险一致的筛查测试订单的患者中,测试完成率没有差异,OR=0.8[0.5,1.3];p=0.36。在平台确定为风险增加的 50 名患者中,立即组的 78.6%和对照组的 68.2%的患者都收到了遗传咨询的建议,但每个组只有一个人进行了转介。

结论

FHH 工具可以准确评估和记录 CRC 风险增加患者的临床需求。需要进一步探讨采取这些建议的障碍。

试验注册

ClinicalTrials.gov NCT02247336 https://clinicaltrials.gov/ct2/show/NCT02247336.

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