Baggett Travis P, Barbosa Teixeira Joana, Rodriguez Elijah C, Anandakugan Nillani, Sporn Nora, Chang Yuchiao, Percac-Lima Sanja, Park Elyse R, Rigotti Nancy A
Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States of America; Mongan Institute, Massachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Institute for Research, Quality & Policy in Homeless Health Care, Boston Health Care for the Homeless Program, Boston, MA, United States of America.
Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, United States of America.
Contemp Clin Trials. 2022 Feb;113:106666. doi: 10.1016/j.cct.2021.106666. Epub 2021 Dec 28.
Lung cancer is a major cause of death among people experiencing homelessness, with mortality rates more than double those in the general population. Lung cancer screening (LCS) with low-dose computed tomography (LDCT) could reduce lung cancer deaths in this population, although the circumstances of homelessness present multiple barriers to LCS LDCT completion. Patient navigation is a promising strategy for overcoming these barriers.
The Investigating Navigation to Help Advance Lung Equity (INHALE) Study is a pragmatic randomized controlled trial of patient navigation for LCS among individuals receiving primary care at Boston Health Care for the Homeless Program (BHCHP). Three hundred BHCHP patients who meet Medicare/Medicaid criteria for LCS will be randomized 2:1 to usual care with (n = 200) or without (n = 100) LCS navigation. Following a structured, theory-based protocol, the patient navigator assists with each step in the LCS process, providing lung cancer education, facilitating shared decision-making visits with primary care providers (PCPs), assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, and offering tobacco cessation support for smokers. The primary outcome is receipt of LCS LDCT at 6 months. Using a sequential explanatory mixed methods approach, qualitative interviews with participants and PCPs will aid in interpreting and contextualizing the trial results.
This trial will produce the first experimental evidence on patient navigation for cancer screening in a homeless health care setting. Results could inform cancer health equity efforts at the 299 Health Care for the Homeless programs that serve over 900,000 patients annually in the US.
肺癌是无家可归者死亡的主要原因,其死亡率是普通人群的两倍多。低剂量计算机断层扫描(LDCT)肺癌筛查(LCS)可以降低该人群的肺癌死亡率,尽管无家可归的状况给完成LCS LDCT带来了多重障碍。患者导航是克服这些障碍的一种有前景的策略。
“助力推进肺癌公平性的调查性导航(INHALE)研究”是一项务实的随机对照试验,针对在波士顿无家可归者医疗保健项目(BHCHP)接受初级保健的个体进行LCS患者导航研究。300名符合医疗保险/医疗补助LCS标准的BHCHP患者将按2:1随机分为接受(n = 200)或不接受(n = 100)LCS导航的常规护理组。按照基于理论的结构化方案,患者导航员协助LCS过程中的每一步,提供肺癌教育,促进与初级保健提供者(PCP)的共同决策就诊,协助安排和参加LCS LDCT预约,在需要时安排随访,并为吸烟者提供戒烟支持。主要结局是在6个月时接受LCS LDCT。采用顺序解释性混合方法,对参与者和PCP进行定性访谈将有助于解释试验结果并将其置于背景中。
这项试验将产生关于在无家可归者医疗保健环境中进行癌症筛查患者导航的首个实验证据。结果可为美国每年为90多万患者提供服务的299个无家可归者医疗保健项目的癌症健康公平性工作提供参考。