Contemporary clinical trials · 2021
Patient navigation to promote lung cancer screening in a community health center for people experiencing homelessness: Protocol for a pragmatic randomized controlled trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Baggett Travis P, Barbosa Teixeira Joana, Rodriguez Elijah C, Anandakugan Nillani, Sporn Nora, Chang Yuchiao, Percac-Lima Sanja, Park Elyse R, Rigotti Nancy A
Аннотация
BACKGROUND: 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.
METHODS: 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.
DISCUSSION: 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.
METHODS: 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.
DISCUSSION: 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.