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Behavioral Intervention

Study 1 (Study of Patients with Uncertain LCS Eligibility) Intervention Arm for Lung Cancer (MyLungHealth Trial)

N/A

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year trial period

Awards & highlights

MyLungHealth Trial Summary

This trial aims to improve early lung cancer screening by using a patient-centered intervention called MyLungHealth. The intervention will be delivered through the patient portal to help identify more eligible patients and support informed decision

Who is the study for?

The MyLungHealth study is for people aged 50-79 who have a history of smoking and have visited a participating primary care clinic in the past year. Participants must also have used the patient portal at least once in the previous year.Check my eligibility

What is being tested?

This trial tests MyLungHealth, an intervention aimed to improve lung cancer screening rates by identifying eligible patients and supporting informed decision-making through a patient portal called DecisionPrecision+.See study design

What are the potential side effects?

Since this trial involves informational interventions rather than medications or medical procedures, traditional physical side effects are not expected.

MyLungHealth Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year trial period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year trial period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year trial period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Study 1 : Percentage of participants identified as eligible for LCS.

Study 2 : Percentage of participants for whom LDCT was ordered.

Secondary outcome measures

Study 1 : Percentage of participants for whom LDCT was completed.

Study 1 : Percentage of participants for whom LDCT was ordered.

Study 2 : Percentage of participants for whom LCS care gap was closed.

+1 more

MyLungHealth Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Study 2 (Study of Patients with Documented LCS Eligibility) Intervention ArmExperimental Treatment2 Interventions

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.

Group II: Study 1 (Study of Patients with Uncertain LCS Eligibility) Intervention ArmExperimental Treatment1 Intervention

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.

Group III: Study 1 (Study of Patients with Uncertain LCS Eligibility) Control ArmActive Control1 Intervention

In Study 1 (Study of Patients with Uncertain LCS Eligibility), patients allocated to the control arm will not be exposed to the project intervention unless their EHR data change during the trial so that they have documented LCS eligibility. In these rare cases, these patients will be exposed to the intervention provided to patients in the control arm of Study 2 but will not be considered participants in Study 2.

Group IV: Study 2 (Study of Patients with Documented LCS Eligibility) Control ArmActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of UtahLead Sponsor

1,100 Previous Clinical Trials

1,736,486 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing research study?

"Yes, the details available on clinicaltrials.gov imply that this investigation is presently seeking volunteers. Initially shared on March 28th, 2024, and most recently revised on April 3rd, 2024, the trial aims to recruit a total of 42,415 participants from two distinct locations."

Answered by AI

What are the intended results that researchers hope to achieve through this medical study?

"The primary goal of this clinical investigation, to be assessed over a span of approximately one year, is to assess the Percentage of participants eligible for LCS. Additional aims comprise examining the Percentage of patients who underwent LDCT as part of Study 2 and determining if their LCS care gap was resolved through various interventions such as LDCT completion or other chest CT scans based on shared decision-making (SDM). Furthermore, secondary objectives involve evaluating the proportion of participants who completed LDCT during the trial period for both Study 1 and Study 2."

Answered by AI

Is there an age requirement that excludes patients over 55 from participating in this research study?

"Participants aged between 50 and 79 are eligible for this clinical trial. There are a total of 35 investigations focused on individuals below 18 years old and another 1618 studies targeting those above the age of 65."

Answered by AI

What is the current number of participants being recruited for this medical study?

"Indeed, the information on clinicaltrials.gov confirms that this particular clinical trial is presently seeking eligible participants. The trial was first listed on March 28th, 2024 and most recently updated on April 3rd, 2024. In total, the study aims to recruit a substantial number of 42,415 patients across two designated locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kensaku Kawamoto, MD, PhD, MHS 2024. "The MyLungHealth Study Protocol: Engaging Patients to Enable Interoperable Lung Cancer Decision Support at Scale". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06338592.

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