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

Lung Cancer Clinical Trial

— MyLungHealth  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338592
• Other study ID #: UUtah_00153806
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: University of Utah
• Contact: Kensaku Kawamoto, MD, PhD
• Phone: 8015878076
• Email: kensaku.kawamoto[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 42415
• Est. completion date: December 31, 2025
• Est. primary completion date: March 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York
United States	University of Utah Health	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study 1 primary outcome: Percentage of participants identified as eligible for LCS.	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.	1 year trial period
Primary	Study 2 primary outcome: Percentage of participants for whom LDCT was ordered.	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.	1 year trial period
Secondary	Study 1 secondary outcome: Percentage of participants for whom LDCT was ordered.	Secondary outcomes for Study 1 will be the percentage of participants for whom LDCT was ordered during the 1-year trial.	1 year trial period
Secondary	Study 1 secondary outcome: Percentage 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
Secondary	Study 2 secondary outcome: Percentage 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
Secondary	Study 2 secondary outcome: Percentage of participants for whom LCS care gap was closed.	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.	1 year trial period