Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation

Not Applicable

Completed

• Conditions: Smoking Cessation; Lung Cancer
• Interventions: Other: Patient decision aid

• Registration Number: NCT04897568
• Lead Sponsor: University of Colorado, Denver

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 pre-post 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 up to 8 months. The first period of 2 months is for baseline data, the second and every other period of 2 months is for intervention (pre-post design). Each 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 Timeline

• Study Start: 2020-07-15
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Primary Completion: 2023-04-30
• Study Completion: 2023-11-29
• Results First Submitted: 2024-03-26
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Results First Posted: 2024-10-15
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Asymptomatic to lung cancer symptoms
• Tobacco smoking history of 20+ pack-years
• Current smoker or quit within last 15 years

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Exclusion Criteria

• A patient that does not meet inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patient decision aid	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).

Primary Outcome Measures

Name	Time	Method
Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Baseline Survey	Baseline	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	1 month follow-up	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?

Secondary Outcome Measures

Name	Time	Method
Patient Knowledge About Lung Cancer	1 month follow up	Patient knowledge about lung cancer will be measured by overall knowledge score calculated from 15 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 15 questions. The overall knowledge score will range from 0-15 where 0 is no correct answer (lowest knowledge) and 15 is all correct answers (highest knowledge).; More correct answers indicate higher level of knowledge and higher score.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States