TY - JOUR
T1 - Patient navigation for lung cancer screening in an urban safety-net system
T2 - Protocol for a pragmatic randomized clinical trial
AU - Gerber, David E.
AU - Hamann, Heidi A.
AU - Santini, Noel O.
AU - Abbara, Suhny
AU - Chiu, Hsienchang
AU - McGuire, Molly
AU - Quirk, Lisa
AU - Zhu, Hong
AU - Lee, Simon J.Craddock
N1 - Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2017/9
Y1 - 2017/9
N2 - The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55–77 years, smoking history ≥ 30 pack-years, quit within 15 years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016.
AB - The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55–77 years, smoking history ≥ 30 pack-years, quit within 15 years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016.
KW - Adherence
KW - Lung cancer screening
KW - Navigation
KW - Patient reported outcomes
KW - Pragmatic trial
KW - Smoking cessation
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U2 - 10.1016/j.cct.2017.07.003
DO - 10.1016/j.cct.2017.07.003
M3 - Article
C2 - 28689056
AN - SCOPUS:85022205072
SN - 1551-7144
VL - 60
SP - 78
EP - 85
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -