Clinical trial NCT06338592: The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lung Neoplasms/Diagnosis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 42415
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a patient randomized trial that includes two sub-studies, with 2 arms each.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Study 1 primary outcome: Percentage of participants identified as eligible for LCS.
timeFrame: 1 year trial period
measure: Study 2 primary outcome: Percentage of participants for whom LDCT was ordered.
timeFrame: 1 year trial period
Secondary outcomes:
measure: Study 1 secondary outcome: Percentage of participants for whom LDCT was ordered.
timeFrame: 1 year trial period
measure: Study 1 secondary outcome: Percentage of participants for whom LDCT was completed.
timeFrame: 1 year trial period
measure: Study 2 secondary outcome: Percentage of participants for whom LDCT was completed.
timeFrame: 1 year trial period
measure: Study 2 secondary outcome: Percentage of participants for whom LCS care gap was closed.
timeFrame: 1 year trial period
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
affiliation: University of Utah
name: Kensaku Kawamoto, MD, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.