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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Lung Cancer; Smoking Cessation

Treatments: Other: Patient decision aid

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT04897568

19-1706.cc

NCI-2021-04394 (Other Identifier)

P50CA244688 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will consist of each participant and clinic before the intervention (baseline, first 2 months).

Patient decision aid

Active Comparator group

Description:

The intervention group will consist of each participant and clinic once they move to the intervention phase (after the first 2 months).

Treatment:

Other: Patient decision aid