Lung Cancer, Smoking Cessation
Conditions
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.
Interventions
OTHERPatient 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.
Sponsors
High Plains Research Network
National Cancer Institute (NCI)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Knowledge About Lung Cancer | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control (Pre-intervention) The control group will consist of each participant and clinic before the intervention (baseline, first 2 months). | 64 |
| Patient Decision Aid (Post-intervention) The intervention group will consist of each participant and clinic once they move to the intervention phase (pre-post design)
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. | 54 |
| Total | 118 |
Baseline characteristics
| Characteristic | Control (Pre-intervention) | Patient Decision Aid (Post-intervention) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 42 Participants | 94 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) White | 58 Participants | 48 Participants | 106 Participants |
| Sex: Female, Male Female | 33 Participants | 28 Participants | 61 Participants |
| Sex: Female, Male Male | 31 Participants | 26 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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?
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Baseline Survey | 0 participants |
| Patient Decision Aid | Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Baseline Survey | 0 participants |
Primary
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?
Time frame: 1 month follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Follow-up Survey | 0 participants |
| Patient Decision Aid | Count of Participants Who's Health Visit Adhered to the LCS Guidelines and CMS Coverage Criteria in Rural Primary Care Practices: Follow-up Survey | 0 participants |
Secondary
Patient Knowledge About Lung Cancer
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Patient Knowledge About Lung Cancer | 8.1 score on a scale | Standard Deviation 2.3 |
| Patient Decision Aid | Patient Knowledge About Lung Cancer | 8.5 score on a scale | Standard Deviation 1.5 |
Secondary
Patient Knowledge About Lung Cancer
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.
Time frame: 1 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Patient Knowledge About Lung Cancer | 8.1 score on a scale | Standard Deviation 2.3 |
| Patient Decision Aid | Patient Knowledge About Lung Cancer | 8.5 score on a scale | Standard Deviation 1.5 |