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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04897568
Other study ID # 19-1706.cc
Secondary ID P50CA244688NCI-2
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date November 29, 2023

Study information

Verified date March 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The intervention is aimed to improve adherence to the lung cancer screening (LCS) guidelines and Centers for Medicare and Medicaid Services (CMS) coverage criteria to conduct shared decision-making (SDM) and provide smoking cessation services in rural primary care practices.


Description:

The pilot intervention will engage no more than 300 patients using a pragmatic, pre-post design guided by an enhanced RE-AIM/PRISM framework. The primary goal of this intervention is to improve LCS practice by offering a formal SDM process and smoking cessation support aligned with the CMS coverage criteria. The investigators will conduct a type II effectiveness implementation hybrid trial using a stepped wedge design to evaluate the effectiveness (co-primary outcomes of LCS and decision quality) and implementation at four rural clinics. Space precludes discussion of pragmatic design features, but this study was designed to be pragmatic using the PRECIS-2 criteria and it scores highly on almost all PRECIS-2 dimensions. Each clinic will recruit the minimum of 9 patients eligible to LCS (based on CMS guidelines) every 2 months for the total of 8 months. The first period of 2 months is for baseline data, the second period of 2 months is for step 1 of the stepped wedge design, the third period of 2 months is for step 2 and finally the last 4th period of 2 months is for step 3 of the stepped wedge design. Each participating patient will receive 2 surveys (one immediately after the doctor's visit and a second one a month later). The intervention will be in the form of patient decision aid (information flyer) the participant receives during a healthcare provider visit.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date November 29, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Asymptomatic to lung cancer symptoms - Tobacco smoking history of 20+ pack-years - Current smoker or quit within last 15 years Exclusion Criteria: - A patient that does not meet inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient decision aid
Each subject will receive an informational flyer describing lung cancer screening options and smoking cessation from a trained person on the medical staff at each clinic. Staff will lead a shared decision-making discussion with the patient.

Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (3)

Lead Sponsor Collaborator
University of Colorado, Denver High Plains Research Network, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Count of participants who's health visit adhered to the LCS guidelines and CMS coverage criteria in rural primary care practices: baseline survey The adherence to the LCS guidelines and CMS coverage criteria to conduct SDM and provide smoking cessation services in rural primary care practices (is a latent variable) and will be measured as a composite measure using variables in a baseline survey administered immediately after healthcare provider's visit (baseline).
A survey tool will be developed and used to count "Yes" response to the following survey questions:
Were you given a decision aid during your last clinic visit/call? Was the clinic provider or staff able to go over the decision aid together with you during your last clinic visit/call? Were you recommended for a low-dose CAT scan by your provider during your last clinic visit/call?
Baseline
Primary Count of participants who's health visit adhered to the LCS guidelines and CMS coverage criteria in rural primary care practices: follow-up survey The adherence to the LCS guidelines and CMS coverage criteria to conduct SDM and provide smoking cessation services in rural primary care practices (is a latent variable) and will be measured as a composite measure using variables in a baseline survey administered immediately after the healthcare provider's visit (follow-up).
A survey tool will be developed and used to count "Yes" response to the following survey questions:
Were you given a decision aid during your last clinic visit/call? Was the clinic provider or staff able to go over the decision aid together with you during your last clinic visit/call? Were you recommended for a low-dose computerized axial tomography (CAT) scan by your provider during your last clinic visit/call?
1 month follow-up
Secondary Patient knowledge about lung cancer Patient knowledge about lung cancer will be measured by 5 survey questions previously used by Lau et al in their peer-reviewed manuscript published in the American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. The level of knowledge will be assessed based on correct answers to the following survey questions:
Factors that increase chances of developing lung cancer include;
Possible benefits of lung cancer screening are;
Possible harms of lung cancer screening include;
Please indicate whether each of the following individuals would be eligible for screening based on their age. They all meet the smoking status and pack-year criteria;
What percentage of lumps found on your lungs by the CT screening is NOT going to be cancer?
More correct answers indicate higher level of knowledge.
Baseline
Secondary Patient knowledge about lung cancer Patient knowledge about lung cancer will be measured by 5 survey questions previously used by Lau et al in their peer-reviewed manuscript published in the American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening. The level of knowledge will be assessed based on correct answers to the following survey questions:
Factors that increase the chances of developing lung cancer include;
Possible benefits of lung cancer screening are;
Possible harms of lung cancer screening include;
Please indicate whether each of the following individuals would be eligible for screening based on their age. They all meet the smoking status and pack-year criteria;
What percentage of lumps found on your lungs by the CT screening is NOT going to be cancer?
More correct answers indicate higher level of knowledge.
1 month follow up
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