Clinical trial NCT04897568: Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation
Official title: Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Smoking Cessation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: High Plains Research Network
name: National Cancer Institute (NCI)
First posted: 2021-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Baseline Survey
timeFrame: Baseline
measure: Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Follow-up Survey
timeFrame: 1 month follow-up
Secondary outcomes:
measure: Patient Knowledge About Lung Cancer
timeFrame: Baseline
measure: Patient Knowledge About Lung Cancer
timeFrame: 1 month follow up
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Russell Glasgow, MD
role: PRINCIPAL_INVESTIGATOR
References: