Trial Outcomes & Findings for Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening (NCT NCT04498052)
NCT ID: NCT04498052
Last Updated: 2025-03-24
Results Overview
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.
COMPLETED
NA
1855 participants
Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
2025-03-24
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Period 1 (Clinician-facing Intervention)
STARTED
|
1219
|
|
Period 1 (Clinician-facing Intervention)
COMPLETED
|
1219
|
|
Period 1 (Clinician-facing Intervention)
NOT COMPLETED
|
0
|
|
Period 2 (Clinician + Patient Tools)
STARTED
|
1255
|
|
Period 2 (Clinician + Patient Tools)
COMPLETED
|
1255
|
|
Period 2 (Clinician + Patient Tools)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a Scalable Decision Support and Shared Decision Making Tool for Lung Cancer Screening
Baseline characteristics by cohort
| Measure |
Participants
n=1104 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.
|
|---|---|
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Age, Continuous
|
65.0 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
470 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
634 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American, non-Hispanic
|
20 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic, any race
|
59 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
946 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
79 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1104 participants
n=99 Participants
|
|
No. visits per patient
|
3.0 visits
n=99 Participants
|
|
High-benefit personalized screening benefit level
|
694 Participants
n=99 Participants
|
|
>= 1 pulmonary visit in study period
|
42 Participants
n=99 Participants
|
|
Time smoked
|
40.0 years
n=99 Participants
|
|
Cigarettes per day
|
20.0 cigarettes per day
n=99 Participants
|
|
Current smoker
|
550 Participants
n=99 Participants
|
|
Former smoker (quit < 15 y ago)
|
554 Participants
n=99 Participants
|
|
Time since last smoked
|
7.0 years
n=99 Participants
|
|
Insurance
Commercial
|
337 Participants
n=99 Participants
|
|
Insurance
Government
|
725 Participants
n=99 Participants
|
|
Insurance
Self-pay
|
42 Participants
n=99 Participants
|
|
Patient portal use in preceding year
|
700 Participants
n=99 Participants
|
|
Telehealth primary care visit in preceding year
|
398 Participants
n=99 Participants
|
|
COVID-19 hospitalizations per day in Utah, median
|
15.9 hospitalizations per participant
n=99 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline periodThe 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.
Outcome measures
| Measure |
Patients Eligible for LDCT Lung Cancer Screening
n=1255 Participants
Patients aged 55-80 years who have smoked ≥30 pack-years and were a current smoker or quit smoking in the past 15 years.
|
|---|---|
|
Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed
|
588 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 18 months for the intervention periodThe number of participants who used the intervention was measured. The usage was measured through system logs and data from the enterprise data warehouse.
Outcome measures
| Measure |
Patients Eligible for LDCT Lung Cancer Screening
n=1255 Participants
Patients aged 55-80 years who have smoked ≥30 pack-years and were a current smoker or quit smoking in the past 15 years.
|
|---|---|
|
Number of Participants Who Used the Intervention
|
168 Participants
|
Adverse Events
Patients Eligible for LDCT Lung Cancer Screening
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kensaku Kawamoto, MD, PhD, MHS / Associate Chief Medical Information Officer
University of Utah
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place