Decision Support Tool for Lung Cancer Screening

N/A

Waitlist Available

Led By Kensaku Kawamoto, MD, PhD, MHS

Research Sponsored by University of Utah

Eligibility Criteria Checklist

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

Must have

Does not already have lung cancer

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to increase the use of low-dose CT scans to screen for lung cancer by developing and disseminating patient-centered clinical decision support tools. These tools will be integrated with electronic health records and clinical workflows, and will prompt shared decision making when patients meet screening criteria. The goal is to promote standard of care that is endorsed by the Centers for Medicare & Medicaid Services and the US Preventive Services Task Force.

Who is the study for?

This trial is for people aged 55 to 80 who are patients at University of Utah primary care clinics, have a history of heavy smoking (30+ pack-years), and are either current smokers or quit within the last 15 years. It's not for those already diagnosed with lung cancer.

What is being tested?

The study tests a new tool that helps doctors and patients decide together if lung cancer screening is right. The tool works with electronic health records, prompts shared decision-making when criteria are met, and provides personalized info on screening pros and cons.

What are the potential side effects?

Since this trial involves decision support tools rather than medications or medical procedures, traditional side effects aren't expected. However, there may be psychological impacts from discussing potential benefits and harms of lung cancer screening.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 18 months for the intervention period and 12 months for the baseline period

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months for the intervention period and 12 months for the baseline period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in LDCT screening rate among eligible patients

Secondary study objectives

Estimated number of lung cancer deaths prevented

Estimated number of major complications

Other study objectives

Rate of use of the intervention

Return on investment

Usability of the intervention as measured by System Usability Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients eligible for LDCT lung cancer screeningExperimental Treatment1 Intervention

This population will consist of patients eligible for, or potentially eligible for, LDCT lung cancer screening according to USPSTF guidelines, who are seen by a pilot user of the intervention. The inclusion criteria are (i) \>= 55 years and \<= 80 years old at the time of the visit; (ii) does not already have lung cancer; and (iii) meets USPSTF smoking criteria for LDCT screening (30+ pack-year smoking history and current smoker or quit in the past 15 years) or may meet the criteria if a complete smoking history were taken. USPSTF guidelines may change during the study. In particular, it is anticipated that the guidelines may update during the study whereby the minimum age is reduced to 50 (from 55) and the minimum smoking history is reduced to 20 years (from 30). In the event that the USPSTF guidelines change, the intervention will be updated to match the change to the guidelines. We may also update the study evaluation to match the updated USPSTF guidelines.

0 / 1Eligibility criteria met