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

N/AActive Not RecruitingNCT06338592

University of Utah42,415 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

42,415

Conditions

Lung Cancer Lung Neoplasms/Diagnosis

Interventions

MyLungHealthBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.