Trial Outcomes & Findings for The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale (NCT NCT06338592)
NCT ID: NCT06338592
Last Updated: 2026-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31303 participants
Primary outcome timeframe
1 year trial period
Results posted on
2026-03-27
Participant Flow
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.
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.
Participant milestones
| Measure |
Study 2 (Study of Patients With Documented LCS Eligibility) Intervention Arm
Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
|
Study 2 (Study of Patients With Documented LCS Eligibility) Control Arm
In Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
13
|
13
|
2
|
|
Overall Study
COMPLETED
|
2
|
13
|
13
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale
Baseline characteristics by cohort
| Measure |
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
n=13 Participants
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
n=13 Participants
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
|
Study 2 (Study of Patients With Documented LCS Eligibility) Control Arm
n=2 Participants
In Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders.
|
Study 2 (Study of Patients With Documented LCS Eligibility) Intervention Arm
n=2 Participants
Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR.
|
Total
n=31303 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62 Years
n=56 Participants
|
62 Years
n=62 Participants
|
63 Years
n=123 Participants
|
63 Years
n=53 Participants
|
62 Years
n=654 Participants
|
|
Sex: Female, Male
Female
|
6,555 Participants
n=56 Participants
|
6,589 Participants
n=62 Participants
|
1,078 Participants
n=123 Participants
|
1,152 Participants
n=53 Participants
|
15374 Participants
n=654 Participants
|
|
Sex: Female, Male
Male
|
6,762 Participants
n=56 Participants
|
6,823 Participants
n=62 Participants
|
1,184 Participants
n=123 Participants
|
1,160 Participants
n=53 Participants
|
15929 Participants
n=654 Participants
|
|
Race/Ethnicity, Customized
African American/Black, Non-Hispanic
|
1,127 Participants
n=56 Participants
|
1,071 Participants
n=62 Participants
|
149 Participants
n=123 Participants
|
135 Participants
n=53 Participants
|
2,482 Participants
n=654 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx, any race
|
667 Participants
n=56 Participants
|
717 Participants
n=62 Participants
|
81 Participants
n=123 Participants
|
83 Participants
n=53 Participants
|
1,548 Participants
n=654 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
9,407 Participants
n=56 Participants
|
9,523 Participants
n=62 Participants
|
1,766 Participants
n=123 Participants
|
1,810 Participants
n=53 Participants
|
22,506 Participants
n=654 Participants
|
|
Race/Ethnicity, Customized
Other
|
2,116 Participants
n=56 Participants
|
2,101 Participants
n=62 Participants
|
284 Participants
n=123 Participants
|
266 Participants
n=53 Participants
|
4,767 Participants
n=654 Participants
|
PRIMARY outcome
Timeframe: 1 year trial periodPopulation: This is study 1 primary outcomes, not applicable for study 2 participants.
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.
Outcome measures
| Measure |
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
n=13 Participants
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
n=13 Participants
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
|
|---|---|---|
|
Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening
|
308 Participants
|
635 Participants
|
PRIMARY outcome
Timeframe: 1 year trial periodIn 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.
Outcome measures
| Measure |
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
n=2 Participants
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
n=2 Participants
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
|
|---|---|---|
|
Study 2 Primary Outcome: Count of Participants for Whom LDCT Was Ordered.
|
434 Participants
|
474 Participants
|
SECONDARY outcome
Timeframe: 1 year trial periodIn 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.
Outcome measures
| Measure |
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
n=13 Participants
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
n=13 Participants
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
|
|---|---|---|
|
Study 1 Secondary Outcome: Count of Participants for Whom LDCT Eligibility Status Became Known.
|
925 Participants
|
3,570 Participants
|
SECONDARY outcome
Timeframe: 1 year trial periodSecondary outcomes for Study 1 will be the count of participants for whom LDCT was ordered during the 1-year trial.
Outcome measures
| Measure |
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
n=13 Participants
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
n=13 Participants
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
|
|---|---|---|
|
Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Ordered.
|
350 Participants
|
430 Participants
|
SECONDARY outcome
Timeframe: 1 year trial periodSecondary outcomes for Study 1 will be the percentage of participants for whom LDCT was completed during the 1-year trial.
Outcome measures
| Measure |
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
n=13 Participants
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
n=13 Participants
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
|
|---|---|---|
|
Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.
|
226 Participants
|
275 Participants
|
SECONDARY outcome
Timeframe: 1 year trial periodA secondary outcome for Study 2 will be the percentage of participants for whom LDCT was completed during the 1-year trial.
Outcome measures
| Measure |
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
n=2 Participants
In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.
|
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
n=2 Participants
Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2.
|
|---|---|---|
|
Study 2 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.
|
290 Participants
|
293 Participants
|
Adverse Events
Study 1 (Study of Patients With Uncertain LCS Eligibility) Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 1 (Study of Patients With Uncertain LCS Eligibility) Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 2 (Study of Patients With Documented LCS Eligibility) Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study 2 (Study of Patients With Documented LCS Eligibility) Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place