- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05679349
Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking
Provider Support and Patient Outreach in Lung Cancer Screening
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. Assess intervention impact on lung cancer screening (LCS). II. Assess intervention impact on shared decision making (SDM).
SECONDARY OBJECTIVES:
I. Identify mediators and moderators of LCS. II. Assess intervention implementation barriers and facilitators.
EXPLORATORY OBJECTIVES:
I. Assess intervention impact on:
Ia. LCS referral; Ib. Tobacco treatment services referral; Ic. Repeat annual LCS among participants with a normal initial screening result; Id. Follow-up diagnostic evaluation for participants with an abnormal screening result.
OUTLINE: Providers are randomized to 1 of 2 groups. Patients are randomized to 1 of 2 groups.
PROVIDERS:
GROUP A: PROVIDER SUPPORT GROUP: Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.
GROUP B: PROVIDER CONTROL GROUP: Participants complete survey at baseline and end of study survey.
PATIENTS:
GROUP A: Patients undergo electronic health records (EHR) review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.
GROUP B: Patients undergo EHR review on study and complete telephone survey throughout the trial.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ronald Myers, PhD
- Phone Number: 215-503-4085
- Email: ronald.myers@jefferson.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Sidney Kimmel Cancer Center at Thomas Jefferson University
-
Contact:
- Ronald Myers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- PRACTICE LEVEL:
- Primary care practice (family medicine, geriatrics, internal medicine) in one of the 4 participating health systems
- Practice using the main electronic medical record (EMR) of each system, in order to run appropriate patient recruitment reports
- Practice with at least 50% of practice providers (physicians and advanced care providers) consenting to participate
- PATIENT LEVEL:
- Have an office or telemedicine established patient visit scheduled with a primary care provider in one of the participating practices within next 14 to 25 days
- 50 to 77 years of age
- Have at least a 20-pack-year smoking history (based on self-report at baseline eligibility assessment)
- Currently smoke or have quit smoking within the past 15 years (based on self-report at baseline eligibility assessment)
- Able to communicate in English or Spanish (determined at baseline eligibility assessment)
Exclusion Criteria:
- PATIENT OUTREACH:
Any lung computed tomography (CT) or low-dose computed tomography (LDCT) scan in the past 11 months, current procedural terminology (CPT) Codes are as follows
- G0297 - LDCT screening
- 71250 - CT w/o contrast
- 71260 - CT w/ contrast
- 71270 - CT with and w/o contrast
- 71275 - CT angiography chest
- 78815 - Positron emission tomography computed tomography (PET CT) skull base to mid-thigh
- 78816 - PET CT whole body
- Prior history of lung cancer (The patient's problem list includes a problem with an international classification of diseases (ICD10) code of "Z85.118" or one beginning with "C34.", or by self-report at baseline eligibility assessment)
- Recent hospitalization (Admission date within the last 60 days listed in electronic health record (EHR), or by self-report at baseline eligibility assessment)
- Dementia (diagnosis codes F03.90 or F03.91) in EHR
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A (Providers): (survey, online educational activity)
Participants complete survey on study.
Participants undergo online educational activity on study.
Participants undergo distance learning on study.
|
Complete survey
Undergo online shared decision making training and distance learning
|
Active Comparator: Group B (Providers): (survey)
Participants complete survey at baseline and end of study survey.
|
Complete survey
|
Experimental: Group A (Patients): (EHR, educational activity, counseling))
Patients undergo EHR review on study.
Patients undergo educational activity on study.
Patients also undergo SDM counseling once on study.
|
Undergo electronic health record review
Undergo online shared decision making training and distance learning
Undergo shared decision making counseling
Other Names:
|
Active Comparator: Group B (Patients): (survey)
Patients undergo EHR review on study and complete telephone survey throughout the trial.
|
Complete survey
Undergo electronic health record review
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of initial lung cancer screening (LCS)
Time Frame: Within 4 months of randomization
|
LCS will be assessed through an endpoint electronic medical records (EMR) search, supplemented with a question on the participant endpoint survey to capture any LCS performed outside the health system and/or not captured in the EMR.
|
Within 4 months of randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Referral for LCS
Time Frame: Up to 5 years
|
Referrals for lung cancer screenings will be found by reviewing electronic medical records.
|
Up to 5 years
|
Tobacco cessation services
Time Frame: Up to 5 years
|
Referrals for tobacco treatment services will be found by reviewing medical records.
|
Up to 5 years
|
Repeat annual lung cancer screenings within 11-16 months of original screening
Time Frame: within 11-16 months of original screening
|
Number of repeat screenings will be found by reviewing electronic medical records.
|
within 11-16 months of original screening
|
Diagnostic follow up after initial lung cancer screening
Time Frame: Up to 4 months of screening
|
Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records.
|
Up to 4 months of screening
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22F.808
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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