The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale
- Conditions
- Lung CancerLung Neoplasms/Diagnosis
- Interventions
- Behavioral: DecisionPrecision+Behavioral: MyLungHealth
- Registration Number
- NCT06338592
- Lead Sponsor
- University of Utah
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42415
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study 2 (Study of Patients with Documented LCS Eligibility) Control Arm DecisionPrecision+ In Study 2 (Study of Patients with Documented LCS Eligibility), patients allocated to the control arm will be exposed to the DecisionPrecision+ intervention because DecisionPrecision+ intervention automatically identifies patients with documented LCS eligibility in the EHR. The DecisionPrecision+ intervention is designed to promote LCS and LCS SDM; the intervention consists of provider-facing EHR preventive care reminders, a provider-facing EHR SDM tool, and simple patient-facing preventive care reminders (only available at UUH). Simple patient-facing preventive care reminders will be available at UUH, but not NYU, because NYU does not use this type of reminders. Study 2 (Study of Patients with Documented LCS Eligibility) Intervention Arm MyLungHealth Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR. Study 1 (Study of Patients with Uncertain LCS Eligibility) Intervention Arm MyLungHealth Patients allocated to the intervention arm of Study 1 will be exposed to the MyLungHealth intervention in addition to usual care. The Study 1 MyLungHealth eligibility questionnaires will consist of pre-visit smoking history questions asked through the EHR patient portal to increase the identification of screening-eligible patients (Figure 2). Patients will be prompted to engage in the intervention through pre-visit questionnaires for primary care visits administered up to 7 days prior to the visits. These questions will ask about the patients' smoking history and determine whether patients meet LCS eligibility criteria. Study 1 patients who meet LCS eligibility criteria will be offered the intervention provided to patients in the intervention arm of Study 2 immediately after confirming eligibility but will not be considered participants in Study 2. Study 2 (Study of Patients with Documented LCS Eligibility) Intervention Arm DecisionPrecision+ Patients allocated to the intervention arm will be offered the MyLungHealth education tool in addition to the DecisionPrecision+ intervention. The pre-visit questionnaire will directly invite patients to use the MyLungHealth education app, rather than first asking about smoking history to confirm eligibility. When patients affirm in the patient portal that they were able to successfully open the MyLungHealth education tool, their providers will be notified of their potential interest in LCS through a passive (non-interruptive) prompt in the EHR.
- Primary Outcome Measures
Name Time Method Study 2 primary outcome: Percentage of participants for whom LDCT was ordered. 1 year trial period 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.
Study 1 primary outcome: Percentage of participants identified as eligible for LCS. 1 year trial period 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.
- Secondary Outcome Measures
Name Time Method Study 1 secondary outcome: Percentage of participants for whom LDCT was completed. 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.
Study 2 secondary outcome: Percentage of participants for whom LCS care gap was closed. 1 year trial period 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.
Study 1 secondary outcome: Percentage of participants for whom LDCT was ordered. 1 year trial period Secondary outcomes for Study 1 will be the percentage of participants for whom LDCT was ordered during the 1-year trial.
Study 2 secondary outcome: Percentage of participants for whom LDCT was completed. 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.
Trial Locations
- Locations (2)
NYU Langone Health
🇺🇸New York, New York, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States