The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale
- Conditions
- Lung CancerLung Neoplasms/Diagnosis
- Registration Number
- NCT06338592
- Lead Sponsor
- University of Utah
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42415
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Study 2 primary outcome: Percentage of participants for whom LDCT was ordered. 1 year trial period The primary outcome for Study 2 will be the percentage of participants with an LDCT order placed during the 1-year trial among patients with documented LCS eligibility as per EHR data at the start of the trial.
Study 1 primary outcome: Percentage of participants identified as eligible for LCS. 1 year trial period The primary outcome for Study 1 will be the percentage of participants identified as LCS-eligible patients during the 1-year trial among patients with uncertain LCS eligibility at the start of the trial. Patients will be considered to fulfill this outcome if, at any point during the 1-year trial, the patient's EHR record indicates they meet smoking history eligibility criteria, or a patient affirms they meet eligibility criteria in the patient portal.
- Secondary Outcome Measures
Name Time Method Study 1 secondary outcome: Percentage 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: Percentage of participants for whom LCS care gap was closed. 1 year trial period Another secondary outcome for Study 2 will be the percentage of participants for whom the LCS care gap was closed, defined as the identification and completion of recommended care services among patients eligible for LCS according to the EHR. LCS care-gap closure could be achieved through LDCT completion, other chest CT completion, or documented SDM.
Study 1 secondary outcome: Percentage of participants for whom LDCT was ordered. 1 year trial period Secondary outcomes for Study 1 will be the percentage of participants for whom LDCT was ordered during the 1-year trial.
Study 2 secondary outcome: Percentage 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.
Trial Locations
- Locations (2)
NYU Langone Health
🇺🇸New York, New York, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
NYU Langone Health🇺🇸New York, New York, United StatesDevin Mann, MDPrincipal Investigator