Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation (SDM-LCS-SC)

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Lung Cancer
• Intervention / Treatment: Other: Patient decision aid

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control group will consist of each participant and clinic before the intervention (baseline, first 2 months).
Active Comparator: Patient decision aid; 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).	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.; Other Names: Informational flyer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI); High Plains Research Network
• Investigators: Principal Investigator: Russell Glasgow, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 19-1706.cc; P50CA244688 (U.S. NIH Grant/Contract); NCI-2021-04394 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No