Lung Cancer, Lung Neoplasms/Diagnosis
Conditions
Brief summary
Early lung cancer screening (LCS) through low-dose computed tomography (LDCT) is crucial but underused due to various barriers, including incomplete or inaccurate patient smoking data in the electronic health record and limited time for shared decision-making. The objective of this trial is to investigate a patient-centered intervention, MyLungHealth, delivered through the patient portal. The intervention is designed to improve LCS rates through increased identification of eligible patients and informed decision making.
Detailed description
MyLungHealth is a multi-site pragmatic trial, involving University of Utah Health and New York University Langone Health primary care clinics. The MyLungHealth intervention was developed using a user-centered design process, informed by patient and provider focus groups and interviews. The intervention's effectiveness will be evaluated through a patient-randomized trial, comparing the combined use of MyLungHealth and DecisionPrecision+ (a provider-focused clinical decision support and shared decision-making intervention) against DecisionPrecision+ alone.
Interventions
BEHAVIORALMyLungHealth
MyLungHealth is a patient-centered, EHR-integrated smoking data-quality improvement and education intervention. A key component of the MyLungHealth intervention is a pre-visit LCS eligibility questionnaire asked through the Epic EHR patient portal for individuals with unclear LCS eligibility due to missing or potentially inaccurate data in the EHR. Another key component of the MyLungHealth intervention is an interoperable, patient-centered educational app delivered through the EHR patient portal.
BEHAVIORALDecisionPrecision+
DecisionPrecision+ is a multi-faceted intervention which includes provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This is a patient randomized trial that includes two sub-studies, with 2 arms each.
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
for both study 1 and study 2: * aged 50-79 * a history of smoking (e.g., current or former tobacco use) * seen in a study primary care clinic in the 12 months preceding the start of the trial
Exclusion criteria
for both study 1 and study 2: * \>0 but \< 10 pack-year smoking history or quit more than 15 years ago * No use of the patient portal at least once in the year preceding the start of the study * A lung cancer diagnosis at the start of the study * LDCT completed in the past 3 years * Another chest CT completed in the past year * Structured EHR data indicating LCS SDM was provided in the past 3 years * Exposed to the intervention during the pilot phase * No visit at a study clinic during the trial period when the intervention was available Inclusion criteria for study 1: * a 10-19 pack-year smoking history, an unknown pack-year history, unknown quit date for patients who quit smoking, or a 0 pack-year smoking history Inclusion criteria for study 2: * at least a 20 pack-year smoking history and are a current smoker or have quit within the last 15 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening | 1 year trial period | In Study 1, the primary outcome was the number of patients newly identified as eligible for lung cancer screening during the 12-month follow-up period, defined as having a smoking history of at least 20 pack-years and being a current smoker or having quit within the past 15 years, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal. |
| Study 2 Primary Outcome: Count of Participants for Whom LDCT Was Ordered. | 1 year trial period | In Study 2, which enrolled participants with documented lung cancer screening eligibility at baseline, the primary outcome was the count of participants for whom a low-dose computed tomography (LDCT) lung cancer screening order was placed during the 12-month follow-up period, as identified from structured electronic health record order data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study 1 Secondary Outcome: Count of Participants for Whom LDCT Eligibility Status Became Known. | 1 year trial period | In Study 1, which enrolled participants with uncertain lung cancer screening eligibility at baseline, a secondary outcome was the count of participants for whom lung cancer screening eligibility status became known during the 12-month follow-up period, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal. |
| Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Ordered. | 1 year trial period | Secondary outcomes for Study 1 will be the count of participants for whom LDCT was ordered during the 1-year trial. |
| Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Completed. | 1 year trial period | Secondary outcomes for Study 1 will be the percentage of participants for whom LDCT was completed during the 1-year trial. |
| Study 2 Secondary Outcome: Count of Participants for Whom LDCT Was Completed. | 1 year trial period | A secondary outcome for Study 2 will be the percentage of participants for whom LDCT was completed during the 1-year trial. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKensaku Kawamoto, MD, PhD, MHS
University of Utah
Participant flow
Recruitment details
Participants were identified using electronic health record (EHR) data from primary care clinics at University of Utah Health and New York University Langone Health. Eligible patients were adults aged 50-79 years with a documented smoking history, an active patient portal account, and a primary care visit in the prior 12 months. Recruitment and randomization were fully automated and embedded within the EHR as part of a pragmatic clinical trial.
Pre-assignment details
This was a pragmatic, minimal-risk trial conducted under a waiver of informed consent. Eligibility was determined using pretrial structured EHR data. No in-person screening or consent procedures were performed. Participants were not contacted prior to randomization. No participants were excluded after randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62 Years |
| Race/Ethnicity, Customized African American/Black, Non-Hispanic | 2,482 Participants |
| Race/Ethnicity, Customized Hispanic/Latinx, any race | 717 Participants |
| Race/Ethnicity, Customized Other | 4,767 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 9,523 Participants |
| Sex: Female, Male Female | 1,152 Participants |
| Sex: Female, Male Male | 1,184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13,317 | 0 / 13,412 | 0 / 2,262 | 0 / 2,312 |
| other Total, other adverse events | 0 / 13,317 | 0 / 13,412 | 0 / 2,262 | 0 / 2,312 |
| serious Total, serious adverse events | 0 / 13,317 | 0 / 13,412 | 0 / 2,262 | 0 / 2,312 |
Outcome results
None listed