Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation (SDM-LCS-SC)
Primary Purpose
Lung Cancer, Smoking Cessation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient decision aid
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer
Eligibility Criteria
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
Sites / Locations
- University of Colorado Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Patient decision aid
Arm Description
The control group will consist of each participant and clinic before the intervention (baseline, first 2 months).
The intervention group will consist of each participant and clinic once they move to the intervention phase (stepped-wedge design: practices will be randomized into step 1, 2 or 3; for step 1: the intervention will start at 2 months, for step 2: the intervention will start at 4 months, for step 3: the intervention will start at 6 months).
Outcomes
Primary Outcome Measures
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?
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 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 CAT scan by your provider during your last clinic visit/call?
Secondary Outcome Measures
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 American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening (2015 Dec;49(6):e125-9. doi: 10.1016/j.amepre.2015.07.027). 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.
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 American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening (2015 Dec;49(6):e125-9. doi: 10.1016/j.amepre.2015.07.027). 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.
Full Information
NCT ID
NCT04897568
First Posted
March 3, 2021
Last Updated
September 12, 2023
Sponsor
University of Colorado, Denver
Collaborators
High Plains Research Network
1. Study Identification
Unique Protocol Identification Number
NCT04897568
Brief Title
Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation
Acronym
SDM-LCS-SC
Official Title
Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
High Plains Research Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Smoking Cessation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A type II effectiveness implementation hybrid trial will be conducted using a pre-post design to evaluate the effectiveness (co-primary outcomes of LCS and decision quality) and implementation at four rural clinics.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will consist of each participant and clinic before the intervention (baseline, first 2 months).
Arm Title
Patient decision aid
Arm Type
Active Comparator
Arm Description
The intervention group will consist of each participant and clinic once they move to the intervention phase (stepped-wedge design: practices will be randomized into step 1, 2 or 3; for step 1: the intervention will start at 2 months, for step 2: the intervention will start at 4 months, for step 3: the intervention will start at 6 months).
Intervention Type
Other
Intervention Name(s)
Patient decision aid
Other Intervention Name(s)
Informational flyer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Count of participants who's health visit adhered to the LCS guidelines and CMS coverage criteria in rural primary care practices: baseline survey
Description
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?
Time Frame
Baseline
Title
Count of participants who's health visit adhered to the LCS guidelines and CMS coverage criteria in rural primary care practices: follow-up survey
Description
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 (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 CAT scan by your provider during your last clinic visit/call?
Time Frame
1 month follow-up
Secondary Outcome Measure Information:
Title
Patient knowledge about lung cancer
Description
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 American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening (2015 Dec;49(6):e125-9. doi: 10.1016/j.amepre.2015.07.027). 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.
Time Frame
Baseline
Title
Patient knowledge about lung cancer
Description
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 American Journal of Preventive Medicine titled Evaluation of a Personalized, Web-Based Decision Aid for Lung Cancer Screening (2015 Dec;49(6):e125-9. doi: 10.1016/j.amepre.2015.07.027). 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.
Time Frame
1 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Glasgow, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation
We'll reach out to this number within 24 hrs