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Trial Title:
The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale
NCT ID:
NCT06338592
Condition:
Lung Cancer
Lung Neoplasms/Diagnosis
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a patient randomized trial that includes two sub-studies, with 2 arms each.
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
MyLungHealth
Description:
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.
Arm group label:
Study 1 (Study of Patients with Uncertain LCS Eligibility) Intervention Arm
Arm group label:
Study 2 (Study of Patients with Documented LCS Eligibility) Intervention Arm
Intervention type:
Behavioral
Intervention name:
DecisionPrecision+
Description:
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.
Arm group label:
Study 2 (Study of Patients with Documented LCS Eligibility) Control Arm
Arm group label:
Study 2 (Study of Patients with Documented LCS Eligibility) Intervention Arm
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.
Criteria for 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
Gender:
All
Minimum age:
50 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Devin Mann, MD
Email:
devin.mann@nyulangone.org
Investigator:
Last name:
Devin Mann, MD
Email:
Principal Investigator
Facility:
Name:
University of Utah Health
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kensaku Kawamoto, MD, PhD, MHS
Email:
kensaku.kawamoto@utah.edu
Investigator:
Last name:
Kensaku Kawamoto, MD, PhD, MHS
Email:
Principal Investigator
Start date:
March 28, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of Utah
Agency class:
Other
Source:
University of Utah
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06338592
