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

NCT ID: NCT06338592

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42415 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2025-12-31

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.

Conditions

Lung Cancer; Lung Neoplasms/Diagnosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

MyLungHealth

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

DecisionPrecision+

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

MyLungHealth

Intervention Type: BEHAVIORAL

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.

DecisionPrecision+

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• at least a 20 pack-year smoking history and are a current smoker or have quit within the last 15 years

Exclusion Criteria

• >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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Kensaku Kawamoto, MD, PhD, MHS

Associate Chief Medical Information Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kensaku Kawamoto, MD, PhD, MHS

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

NYU Langone Health

New York, New York, United States

University of Utah Health

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 37142092 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39806641 (View on PubMed)

Other Identifiers

UUtah_00153806

Identifier Type: -

Identifier Source: org_study_id