肺癌筛查决策辅助工具在初级医疗设置中的设计:一项随机临床试验。
Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial.
发表日期:2023 Aug 01
作者:
Marilyn M Schapira, Rebecca A Hubbard, Jeff Whittle, Anil Vachani, Dana Kaminstein, Sumedha Chhatre, Keri L Rodriguez, Lori A Bastian, Jeffrey D Kravetz, Onur Asan, Jason M Prigge, Jessica Meline, Susan Schrand, Jennifer V Ibarra, Deborah A Dye, Julie B Rieder, Jemimah O Frempong, Liana Fraenkel
来源:
Best Pract Res Cl Ob
摘要:
指南建议在开始进行肺癌筛查(LCS)之前实施共享决策。然而,目前缺乏有关如何最好地在临床实践中实施共享决策的证据。本研究旨在评估LCS决策工具(LCSDecTool)对决策质量和LCS接受率的影响。此随机临床试验于2019年3月18日至2021年9月29日,在宾夕法尼亚费城、威斯康辛密尔沃基和康涅狄格州韦斯特黑文的退伍军人事务医疗中心招募参与者,随访至2022年7月18日。年龄在55至80岁之间,吸烟史至少30包年,当前吸烟者或过去15年内戒烟者符合参与资格。排除了15个月内进行过LCS的个体。在发送了招募信或自行推荐的1047名个体中,有140人被招募。基于网络的适合患者和临床医生的LCS决策支持工具与关注对照干预。主要结果是1个月后的决策冲突。次要结果包括立即干预后和干预后3个月的决策冲突、知识、决策后悔和焦虑,以及6个月后的收入水平。在包含140名参与者(中位数年龄64.0岁,IQR,61.0-69.0岁)中,129名(92.1%)为男性,11名(7.9%)为女性。在137名有可用数据的参与者中,75名(53.6%)为非裔美洲人或黑人,62名(44.3%)为白人;还有4名参与者(2.9%)报告了西班牙裔或拉丁裔的身份。1个月时的平均决策冲突分数在LCSDecTool组和对照组之间没有差异(分别为25.7 [95% CI,21.4-30.1] vs 29.9 [95% CI,25.6-34.2];P = .18)。干预后立即LCS知识得分在LCSDecTool组较高(7.0 [95% CI,6.3-7.7] vs 4.9 [95% CI,4.3-5.5];P < .001),并在1个月(6.3 [95% CI,5.7-6.8] vs 5.2 [95% CI,4.5-5.8];P = .03)和3个月(6.2 [95% CI,5.6-6.8] vs 5.1 [95% CI,4.4-5.8];P = .01)后仍较高。LCSDecTool组在6个月时LCS的收入率较高(69人中的26人[37.7%]对照组71人中的15人[21.1%];P = .04)。在这次比较LCSDecTool与对照组的随机临床试验中,1个月后没有对决策冲突产生影响。在一级保健环境中使用的LCSDecTool未能显著降低决策冲突。该干预措施提高了知识和LCS的接受率。这些结果可以为将来的LCS共享决策实施策略和研究提供参考。 ClinicalTrials.gov识别号:NCT02899754。
Guidelines recommend shared decision-making prior to initiating lung cancer screening (LCS). However, evidence is lacking on how to best implement shared decision-making in clinical practice.To evaluate the impact of an LCS Decision Tool (LCSDecTool) on the quality of decision-making and LCS uptake.This randomized clinical trial enrolled participants at Veteran Affairs Medical Centers in Philadelphia, Pennsylvania; Milwaukee, Wisconsin; and West Haven, Connecticut, from March 18, 2019, to September 29, 2021, with follow-up through July 18, 2022. Individuals aged 55 to 80 years with a smoking history of at least 30 pack-years who were current smokers or had quit within the past 15 years were eligible to participate. Individuals with LCS within 15 months were excluded. Of 1047 individuals who were sent a recruitment letter or had referred themselves, 140 were enrolled.A web-based patient- and clinician-facing LCS decision support tool vs an attention control intervention.The primary outcome was decisional conflict at 1 month. Secondary outcomes included decisional conflict immediately after intervention and 3 months after intervention, knowledge, decisional regret, and anxiety immediately after intervention and 1 and 3 months after intervention and LCS by 6 months.Of 140 enrolled participants (median age, 64.0 [IQR, 61.0-69.0] years), 129 (92.1%) were men and 11 (7.9%) were women. Of 137 participants with data available, 75 (53.6%) were African American or Black and 62 (44.3%) were White; 4 participants (2.9%) also reported Hispanic or Latino ethnicity. Mean decisional conflict score at 1 month did not differ between the LCSDecTool and control groups (25.7 [95% CI, 21.4-30.1] vs 29.9 [95% CI, 25.6-34.2], respectively; P = .18). Mean LCS knowledge score was greater in the LCSDecTool group immediately after intervention (7.0 [95% CI, 6.3-7.7] vs 4.9 [95% CI, 4.3-5.5]; P < .001) and remained higher at 1 month (6.3 [95% CI, 5.7-6.8] vs 5.2 [95% CI, 4.5-5.8]; P = .03) and 3 months (6.2 [95% CI, 5.6-6.8] vs 5.1 [95% CI, 4.4-5.8]; P = .01). Uptake of LCS was greater in the LCSDecTool group at 6 months (26 of 69 [37.7%] vs 15 of 71 [21.1%]; P = .04).In this randomized clinical trial of an LCSDecTool compared with attention control, no effect on decisional conflict occurred at 1 month. The LCSDecTool used in the primary care setting did not yield a significant difference in decisional conflict. The intervention led to greater knowledge and LCS uptake. These findings can inform future implementation strategies and research in LCS shared decision-making.ClinicalTrials.gov Identifier: NCT02899754.