Early Detection of Cancer, Lung Neoplasms
Conditions
Keywords
Lung Cancer Screening, Clinical Decision Support, Shared Decision Making
Brief summary
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).
Detailed description
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.
Interventions
OTHEREHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening
The intervention will consist of the following core items: In period 1: * An EHR-integrated shared decision making (SDM) tool for providing information on the risks and benefits of lung cancer screening through low-dose computed tomography (LDCT) testing. This intervention is referred to as Decision Precision+. * Suggestions in the EHR to offer SDM for LDCT for patients eligible for lung cancer screening according to USPSTF guidelines. These suggestions include those provided by the EHR's Health Maintenance module as well as an EHR-integrated Disease Manager system for disease management and health maintenance. 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.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
no masking due to the nature of the intervention
Intervention model description
interrupted time series
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* receives care at University of Utah primary care clinics; * does not already have lung cancer; * meets USPSTF criteria for LDCT screening (currently, age \>= 55 years and \<= 80 years old at the time of the visit; 30+ pack-year smoking history and current smoker or quit in the past 15 years).
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed | Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Used the Intervention | Through study completion, an average of 18 months for the intervention period | The number of participants who used the intervention was measured. The usage was measured through system logs and data from the enterprise data warehouse. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,104 |
| Total | 1,104 |
Baseline characteristics
| Characteristic | Participants |
|---|---|
| >= 1 pulmonary visit in study period | 42 Participants |
| Age, Continuous | 65.0 years |
| Cigarettes per day | 20.0 cigarettes per day |
| COVID-19 hospitalizations per day in Utah, median | 15.9 hospitalizations per participant |
| Current smoker | 550 Participants |
| Former smoker (quit < 15 y ago) | 554 Participants |
| High-benefit personalized screening benefit level | 694 Participants |
| Insurance Commercial | 337 Participants |
| Insurance Government | 725 Participants |
| Insurance Self-pay | 42 Participants |
| No. visits per patient | 3.0 visits |
| Patient portal use in preceding year | 700 Participants |
| Race/Ethnicity, Customized Black or African American, non-Hispanic | 20 Participants |
| Race/Ethnicity, Customized Hispanic, any race | 59 Participants |
| Race/Ethnicity, Customized Other | 79 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 946 Participants |
| Region of Enrollment United States | 1104 participants |
| Sex: Female, Male Female | 470 Participants |
| Sex: Female, Male Male | 634 Participants |
| Telehealth primary care visit in preceding year | 398 Participants |
| Time since last smoked | 7.0 years |
| Time smoked | 40.0 years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 26 / 1,255 |
| other Total, other adverse events | 0 / 1,255 |
| serious Total, serious adverse events | 0 / 1,255 |
Outcome results
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.
Time frame: Through study completion, an average of 18 months for the intervention period and 12 months for the baseline period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Eligible for LDCT Lung Cancer Screening | Number of Participants With Lung Cancer Screening (LCS) Care-Gap Closed | 588 Participants |
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.
Time frame: Through study completion, an average of 18 months for the intervention period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Eligible for LDCT Lung Cancer Screening | Number of Participants Who Used the Intervention | 168 Participants |