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

Conditions

• Lung Cancer
• Lung Neoplasms/Diagnosis

Eligibility Criteria

Sex

ALL

Age

50 Years - 79 Years

Healthy Volunteers

Not accepted

Interventions

• MyLungHealth — 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+ — 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 Details

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.

Key Dates

Start date

Mar 28, 2024

Status verified

Mar 2026

Primary completion

Mar 27, 2025

Completion

Jan 28, 2026

Study Design

Enrollment

31,303 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• 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.
• 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.
• 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.

Primary Outcome Measure

Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening [ Time Frame: 1 year trial period ]

Locations (2)

Find similar trials in New York, NY

Related Studies

• Lung Cancer Biomarkers and Screening
  Recruiting · NYU Langone Health · New York, New York
• Integrated Cancer Repository for Cancer Research
  Recruiting · University of Nebraska · Greenwood Village, Colorado
• Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
  PHASE2 · Recruiting · CivaTech Oncology · New York, New York
• WTC Chest CT Imaging Archive
  Enrolling By Invitation · Icahn School of Medicine at Mount Sinai · New York, New York