The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale (MyLungHealth)

The MyLungHealth Study Protocol: A Pragmatic Patient-Randomized Controlled Trial to Evaluate a Patient-Centered, Electronic Health Record-Integrated Intervention to Enhance Lung Cancer Screening in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Lung Neoplasms/Diagnosis
• Intervention / Treatment: Behavioral: MyLungHealth; Behavioral: DecisionPrecision+

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.

• Study Type: Interventional
• Enrollment (Actual): 31303
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: MyLungHealth; 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.
Active Comparator: 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.	Behavioral: DecisionPrecision+; 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.
Experimental: 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.	Behavioral: MyLungHealth; 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.; Behavioral: DecisionPrecision+; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening	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.	1 year trial period
Study 2 Primary Outcome: Count of Participants for Whom LDCT Was Ordered.	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.	1 year trial period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study 1 Secondary Outcome: Count of Participants for Whom LDCT Eligibility Status Became Known.	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.	1 year trial period
Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Ordered.	Secondary outcomes for Study 1 will be the count of participants for whom LDCT was ordered during the 1-year trial.	1 year trial period
Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.	Secondary outcomes for Study 1 will be the percentage of participants for whom LDCT was completed during the 1-year trial.	1 year trial period
Study 2 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.	A secondary outcome for Study 2 will be the percentage of participants for whom LDCT was completed during the 1-year trial.	1 year trial period

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Kensaku Kawamoto, MD, PhD, MHS, University of Utah

Publications and helpful links

General Publications

• 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.
• Kukhareva PV, Li H, Balbin C, Stevens ER, Mann DM, Butler JM, Caverly TJ, Del Fiol G, Kaphingst KA, Schlechter CR, Tiase VL, Fagerlin A, Zhang Y, Hess R, Flynn MC, Reddy C, Martin D, Warner PB, Nanjo C, Choi J, Ngo-Metzger Q, Kawamoto K. Enhancement of Patient-Centered Lung Cancer Screening: The MyLungHealth Randomized Clinical Trial. JAMA Oncol. 2026 Feb 1;12(2):167-176. doi: 10.1001/jamaoncol.2025.5672.
• Kukhareva P, Balbin C, Stevens E, Mann D, Tiase V, Butler J, Del Fiol G, Caverly T, Kaphingst K, Schlechter CR, Fagerlin A, Li H, Zhang Y, Hess R, Flynn M, Reddy C, Warner P, Choi J, Martin D, Nanjo C, Metzger Q, Kawamoto K. The MyLungHealth study protocol: a pragmatic patient-randomised controlled trial to evaluate a patient-centred, electronic health record-integrated intervention to enhance lung cancer screening in primary care. BMJ Open. 2024 Dec 22;14(12):e087056. doi: 10.1136/bmjopen-2024-087056.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): January 28, 2026

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Neoplasms; Disease
• Other Study ID Numbers: UUtah_00153806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: On completion, study data will be made available in compliance with institutional and sponsor data sharing policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No