Skip to main content
OpenTrials
Completed

NCT Number: NCT06338592

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • No visit at a study clinic during the trial period when the intervention was available

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

Treatment and study plan

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.

Primary outcomes

  1. Study 1 Primary Outcome: Count of Patients Newly Identified as Eligible for Lung Cancer Screening

    Time frame: 1 year trial period

    In Study 1, the primary outcome was the number of patients newly identified as eligible for lung cancer screening during the 12-month follow-up period, defined as having a smoking history of at least 20 pack-years and being a current smoker or having quit within the past 15 years, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal.

  2. Study 2 Primary Outcome: Count of Participants for Whom LDCT Was Ordered.

    Time frame: 1 year trial period

    In Study 2, which enrolled participants with documented lung cancer screening eligibility at baseline, the primary outcome was the count of participants for whom a low-dose computed tomography (LDCT) lung cancer screening order was placed during the 12-month follow-up period, as identified from structured electronic health record order data.

Secondary outcomes

  1. Study 1 Secondary Outcome: Count of Participants for Whom LDCT Eligibility Status Became Known.

    Time frame: 1 year trial period

    In Study 1, which enrolled participants with uncertain lung cancer screening eligibility at baseline, a secondary outcome was the count of participants for whom lung cancer screening eligibility status became known during the 12-month follow-up period, based on structured electronic health record data and patient-reported smoking history collected through the MyLungHealth patient portal.

  2. Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Ordered.

    Time frame: 1 year trial period

    Secondary outcomes for Study 1 will be the count of participants for whom LDCT was ordered during the 1-year trial.

  3. Study 1 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.

    Time frame: 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.

  4. Study 2 Secondary Outcome: Count of Participants for Whom LDCT Was Completed.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study 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

Acronym: MyLungHealth

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 29, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.