Evaluation of the VA Lung Cancer Screening Clinical Demonstration Project

Jackson GL, King HA, McNeil RB, Grubber J, Provenzale D, Datta SK, Sperber NR, Anderson C, Larson M, Barnes LK, Monte RJ, Bechtel HC, Pittman KS, Abbott D, Sims KJ, Whitley LR, Wu R, Kim JA, Chan SH, Martin HL, Kinsinger L. Evaluation of the VA Lung Cancer Screening Clinical Demonstration Project. Durham, NC: VHA National Center for Health Promotion and Disease Prevention (NCP); 2016 Mar 1. 1-255 p. Report No.: 1.

OBJECTIVE: This report presents results of a comprehensive, mixed-method evaluation of the VA Lung Cancer Screening (LCS) Clinical Demonstration Project. The eight-site project was designed to provide guidance on key aspects of potentially implementing low-dose computed tomography (LDCT) for LCS across the healthcare system. BACKGROUND: Lung cancer is the leading cause of cancer-related death in the United States among men and women. Approximately 7,500 cases of lung cancer are diagnosed in VA patients each year; about 5,500 deaths occur. Tobacco smoking is, by far, the leading risk factor for lung cancer, causing about 80-90% of lung cancer cases and deaths. The risk for lung cancer among tobacco smokers remains elevated for several years after cessation. In 2012, Under Secretary for Health Robert Petzel charged the Office of Patient Care Services with conducting a clinical demonstration project of LCS in a limited number of sites. It was not designed as a research study to determine the effectiveness of lung cancer screening in the Veteran population (with or without military-related exposures to Agent Orange or other chemicals). Nor was it designed to answer other questions about LCS protocols, such as the optimal interval or duration of screening. OVERVIEW OF THE DEMONSTRATION PROJECT: The LCS demonstration project was led by the VHA National Center for Health Promotion and Disease Prevention (NCP), in close collaboration with Diagnostic Services, Primary Care Services, and Specialty Care Services in the Office of Patient Care Services (10P4), the Pittsburgh Veterans Engineering Resource Center (VERC), and other VHA national program offices. LCS was conducted in eight facilities: VA New York Harbor Healthcare System, Durham VAMC, Ralph H. Johnson VAMC (Charleston), Cincinnati VAMC, VA Ann Arbor Healthcare System, Portland VAMC, San Francisco VAMC, and Minneapolis VA Healthcare System. Because this project focused on implementation of a consistent and systematic approach, sites with expertise in lung nodule detection and lung cancer treatment, but who were not already engaged in lung screening research, were chosen. All sites hired Lung Cancer Screening Coordinators to coordinate the project locally. Patients seen in primary care at the eight demonstration sites were assessed for appropriateness for LCS based on age, cancer history, life expectancy, prior imaging, and tobacco history. Electronic clinical reminders were built to collect information to identify patients eligible for LCS. Patient education materials were developed by NCP to assist patients in making an informed decision about whether to be screened for lung cancer. NCP also developed handouts for patients explaining the meaning of negative and positive LDCT results. The VERC developed an electronic tracking method to keep track of patients in the screening program. LCS Coordinators used this database and electronic templates to document care in the medical record and to ensure that patients were not lost to follow-up. METHODS: This evaluation has four main components: 1) Estimating the proportion of VA patients who may be eligible for LCS and following the clinical experience through the screening process of patients who chose LCS; 2) Examining the quality of clear, clinical documentation and coordination of care for LCS; 3) Conducting economic analyses of LCS that estimate the budgetary impact of doing an initial round of screening for all clinically-appropriate patients in VA; and 4) Synthesizing information on the facilitators and barriers in establishing an LCS program in VA focused on organizational-level considerations. The main data sources include the VA's electronic health record (including data from clinical decision support tools tracking the process of implementing LCS), summary reports generated through the quality assurance process for clinical documentation, monthly site reports detailing implementation issues encountered, VA's Managerial Cost Account System data, and two rounds of qualitative interviews conducted with site leaders and coordinators during the early and late stages of the project. RESULTS: The LCS demonstration project identified Veterans who were eligible and agreed to lung cancer screening through a stepwise process (Figure 1). A total of 93,033 Veterans were initially assessed as possible candidates for LCS. Smoking status was assessed for 99% of these individuals, but due to incomplete data entry, only 56,478 individuals had complete smoking status data. Of the 56,478 individuals for whom there were complete smoking history data, 32% (n = 18,083) met the smoking history criteria for LCS. Veterans who met smoking history criteria were then eligible for an assessment by a provider to identify any clinical exclusion to screening. Twenty-seven percent (n = 5,035) of Veterans who met smoking history criteria were assessed by a provider for clinical exclusions, and 84.3% (n = 4,246) were determined to meet lung cancer screening eligibility criteria. Of these individuals who were eligible for screening and for whom there were no clinical exclusions, 57.8% (n = 2,452) agreed to be screened for lung cancer. LDCT scans were performed on individuals who met criteria and agreed to screening. A total of 2,106 (85.9%) LDCTs were completed in the initial round of screening through March 31, 2015, with 5,448 LDCTs performed through September 16, 2015. Abnormal findings on LDCTs included lung nodules that needed tracking, lung nodules that were suspicious for possible cancer and needed further workup, and incidental findings. Approximately 48% (n = 1,023) of individuals had an initial LDCT that detected nodules needing to be tracked. Thirty-four Veterans (1.6%) had an initial LDCT scan that resulted in a diagnosis of lung cancer, and possible lung cancer was detected in an additional 31 individuals' initial LDCT scans (1.5%). Combining the number of nodules needing tracking, possible lung cancer, and findings that resulted in a diagnosis of lung cancer, 51.7% (n = 1,088) of Veterans had positive tests requiring tracking or further workup. In addition, 32.4% (n = 683) of individuals who had an initial LDCT had incidental findings such as emphysema, coronary artery calcifications, or abdominal masses or cysts, some of which required additional follow-up. Variation among sites in implementation of lung cancer screening as well as in radiographic interpretation of LDCTs was noted. NCP provided implementation guidance and led the development of tools and resources for the project, but variations were seen in the implementation and use of clinical reminders at each facility, as well as in the provider responsible for ordering the initial LDCT. An assessment of LDCT image quality and consistency of reading scan results was performed on a total of 63 scans that included studies from each site. This assessment found that the adequacy of image quality was questionable in 47.6% of scans, and there were important clinical differences in the interpretation of nodule identification between the reviewing expert and the site-based radiologists in 20-25% of the LDCT interpretations. The LCS demonstration project identified the need for careful coordination of facility resources and staff between radiology, primary care, pulmonary medicine, and other disciplines. The facility-level LCS coordinator played a critical role in tracking, follow-up, facilitating communication between patients and providers, and in coordinating services involved in screening. An economic analysis was conducted from the VA healthcare system's perspective and includes a budget impact analysis. The purpose of a budget impact analysis is to estimate the financial consequences of adopting an intervention in a specific scenario; it is not designed to measure cost-effectiveness of an intervention or even to estimate the actual cost to be borne by the system. Based on the LCS demonstration project, an estimated 2.78 million VA primary care patients aged 55-80 may potentially meet criteria for lung cancer screening. The estimated cost, using a healthcare system perspective, for an initial round of all patients meeting screening guideline criteria was $531 to $907 million in the 11 months following the initial screening, assuming that all patients could be screened at once. This should be viewed as a conservative cost estimate because additional downstream costs beyond the first 11 months are not included. This cost estimate does not include costs that these patients may continue to incur, such as subsequent rounds of screening or facility costs if additional CT scanners are needed. CONCLUSIONS: In summary, the LCS demonstration project showed that implementing a lung cancer screening program in VHA involves a complex program of care to coordinate services and track findings. Approximately two-thirds of the individuals who had LDCTs performed as a part of the demonstration project had abnormal findings including lung nodules and incidental findings, some of which required tracking and clinical follow-up. Considerable variation was noted in the implementation of LCS between facilities. This may reflect the challenges of local resource availability and coordination at each individual site. If lung cancer screening is implemented in VA medical facilities using a program of screening similar to the LCS demonstration project, resource needs will be significant. Estimated costs from a healthcare system perspective for implementing an LCS program throughout the VA system are high. There is a need for a robust, system-wide tracking system and registry that can assist in follow-up of individuals who are receiving lung cancer screening. Radiology resource needs, including radiologists, CT scanners, and radiology staff, are likely to be significant. Implementation of an LCS program will require training for primary care staff, as well as engagement of pulmonary medicine and oncology services. The availability of smoking cessation resources and treatments at each facility is of key importance, as smoking cessation is the most important intervention to prevent the incidence of lung cancer and to decrease the morbidity and mortality associated with lung cancer.