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The purpose of this project is to increase appropriate low-dose computed tomography (LDCT) lung cancer screening through the development and wide dissemination of patient-centered clinical decision support (CDS) tools that (1) are integrated with the electronic health record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when patients meet screening criteria, and (3) enable effective SDM using individually-tailored information on the potential benefits and harms of screening. The study will promote standard of care that is endorsed by the Centers for Medicare & Medicaid Services (CMS) and the US Preventive Services Task Force (USPSTF).
The purpose of this project is to increase appropriate low-dose computed tomography (LDCT) lung cancer screening through the development and wide dissemination of patient-centered clinical decision support (CDS) tools that (1) are integrated with the electronic health record (EHR) and clinical workflows, (2) prompt for shared decision making (SDM) when patients meet screening criteria, and (3) enable effective SDM using individually-tailored information on the potential benefits and harms of screening. The study will promote standard of care that is endorsed by the Centers for Medicare & Medicaid Services (CMS) and the US Preventive Services Task Force (USPSTF). This project is supported both operationally and by an Agency for Healthcare Research and Quality (AHRQ) R18 grant.
This project will leverage Decision Precision, a validated Web-based tool for LDCT SDM developed at the Veterans Health Administration, as well as an initial version of Decision Precision+, an EHR-integrated version of the tool which can be accessed directly in the EHR and auto-populate relevant patient data in the tool instead of requiring manual data entry.
This study will be an 18-month interrupted time series study conducted at the University of Utah Health primary care clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients eligible for LDCT lung cancer screening | Experimental | This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to 2013 USPSTF guidelines. The inclusion criteria are (i) >= 55 years and <= 80 years old at the time of the visit; (ii) does not already have lung cancer; and (iii) meets USPSTF smoking criteria for LDCT screening (30+ pack-year smoking history and current smoker or quit in the past 15 years) or may meet the criteria if a complete smoking history were taken. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening | Other | The intervention will consist of the following core items: In period 1:
In period 2: - Same as period 1 + simple patient reminders in the patient portal. Following roll-out, clinic leaders may also receive periodic feedback on use of the intervention and LDCT screening rates, as well as advice on how to improve intervention adoption. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed | The LCS care gap was considered closed if one or more of the following events occurred: (1) LDCT completion in the past year, (2) completion of another chest CT in the past year, or (3) SDM documentation in the past 3 years for eligible patients. To assess population care-gap closure levels at the end of each study period, we estimated the care-gap closure status for all patients who had primary care visits in the 12 months preceding the last day of the period. Using structured EHR data, SDM was considered documented if a clinician noted the need for LCS discussion was addressed, the patient declined screening, or LCS was not appropriate. | Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Used the Intervention | The number of participants who used the intervention was measured. The usage was measured through system logs and data from the enterprise data warehouse. | Through study completion, an average of 18 months for the intervention period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kensaku Kawamoto, MD, PhD, MHS | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23425165 | Background | Tammemagi MC, Katki HA, Hocking WG, Church TR, Caporaso N, Kvale PA, Chaturvedi AK, Silvestri GA, Riley TL, Commins J, Berg CD. Selection criteria for lung-cancer screening. N Engl J Med. 2013 Feb 21;368(8):728-36. doi: 10.1056/NEJMoa1211776. | |
| 38848065 | Derived | Kukhareva PV, Li H, Caverly TJ, Fagerlin A, Del Fiol G, Hess R, Zhang Y, Butler JM, Schlechter C, Flynn MC, Reddy C, Choi J, Balbin C, Warner IA, Warner PB, Nanjo C, Kawamoto K. Lung Cancer Screening Before and After a Multifaceted Electronic Health Record Intervention: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415383. doi: 10.1001/jamanetworkopen.2024.15383. |
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We are not planning to make individual participant data (IPD) available to other researchers.
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This is a non-randomized control study, where all eligible patients who had a visit in a pre-specified time period were assigned to that period. Therefore, some patients in periods 1 and 2 were the same, but some were different, resulting in 1855 patients in total, including 1104 in the baseline period, 1219 patients in period 1, and 1255 patients in period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Eligible for LDCT Lung Cancer Screening | This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to 2013 USPSTF guidelines. The inclusion criteria are (i) >= 55 years and <= 80 years old at the time of the visit; (ii) does not already have lung cancer; and (iii) meets USPSTF smoking criteria for LDCT screening (30+ pack-year smoking history and current smoker or quit in the past 15 years) or may meet the criteria if a complete smoking history were taken. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Clinician-facing Intervention) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2024 |
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interrupted time series
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no masking due to the nature of the intervention
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| 37142092 | Derived | Kukhareva PV, Li H, Caverly TJ, Del Fiol G, Fagerlin A, Butler JM, Hess R, Zhang Y, Taft T, Flynn MC, Reddy C, Martin DK, Warner IA, Rodriguez-Loya S, Warner PB, Kawamoto K. Implementation of Lung Cancer Screening in Primary Care and Pulmonary Clinics: Pragmatic Clinical Trial of Electronic Health Record-Integrated Everyday Shared Decision-Making Tool and Clinician-Facing Prompts. Chest. 2023 Nov;164(5):1325-1338. doi: 10.1016/j.chest.2023.04.040. Epub 2023 May 3. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 (Clinician + Patient Tools) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Study eligibility criteria were evaluated at the level of primary care visits (office visits or telehealth visits) during the study period. Patients were eligible if they met 2013 USPSTF LCS eligibility criteria at the time of the visit and had at least 1 primary care visit in the preceding year. Per USPSTF guidelines, a person qualified for LCS if they were aged 55 to 80 years, had a smoking history of 30 pack-years or greater, actively smoked or had quit in the previous 15 years, and had not been diagnosed with lung cancer. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| No. visits per patient | Median | Inter-Quartile Range | visits |
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| High-benefit personalized screening benefit level | The screening benefit level was reported in accordance with guidance from the American College of Chest Physicians to identify patients who might obtain the most benefit from screening (high-benefit patients). To identify high-benefit patients, we used LYFS-CT models, with a benchmark of an anticipated gain of at least 16.2 days of life. | Count of Participants | Participants |
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| >= 1 pulmonary visit in study period | To ensure the patient population was stable across study periods, we assessed patient characteristics including receipt of care in pulmonary clinics at Baseline Period. This is a baseline characteristic measured in the Baseline Period, not a study outcome. | Count of Participants | Participants |
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| Time smoked | Median | Inter-Quartile Range | years |
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| Cigarettes per day | Median | Inter-Quartile Range | cigarettes per day |
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| Current smoker | Count of Participants | Participants |
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| Former smoker (quit < 15 y ago) | Count of Participants | Participants |
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| Time since last smoked | Median | Inter-Quartile Range | years |
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| Insurance | Count of Participants | Participants |
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| Patient portal use in preceding year | Count of Participants | Participants |
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| Telehealth primary care visit in preceding year | Count of Participants | Participants |
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| COVID-19 hospitalizations per day in Utah, median | Median | Inter-Quartile Range | hospitalizations per participant |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed | The LCS care gap was considered closed if one or more of the following events occurred: (1) LDCT completion in the past year, (2) completion of another chest CT in the past year, or (3) SDM documentation in the past 3 years for eligible patients. To assess population care-gap closure levels at the end of each study period, we estimated the care-gap closure status for all patients who had primary care visits in the 12 months preceding the last day of the period. Using structured EHR data, SDM was considered documented if a clinician noted the need for LCS discussion was addressed, the patient declined screening, or LCS was not appropriate. | Posted | Count of Participants | Participants | Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period |
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| Other Pre-specified | Number of Participants Who Used the Intervention | The number of participants who used the intervention was measured. The usage was measured through system logs and data from the enterprise data warehouse. | Posted | Count of Participants | Participants | Through study completion, an average of 18 months for the intervention period |
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The study period included 12 months baseline period and 18 months post-intervention implementation period.
All-cause mortality in the preceding year was determined from the EHR data during the study period.
Other adverse events were determined from the provider's and patient's reports.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Eligible for LDCT Lung Cancer Screening | Patients aged 55-80 years who have smoked ≥30 pack-years and were a current smoker or quit smoking in the past 15 years. | 26 | 1,255 | 0 | 1,255 | 0 | 1,255 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kensaku Kawamoto, MD, PhD, MHS / Associate Chief Medical Information Officer | University of Utah | 801-581-4080 | kensaku.kawamoto@utah.edu |
| Dec 9, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| White, non-Hispanic |
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| Other |
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| Self-pay |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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