Trial Outcomes & Findings for Shared Decision Making in Rural Primary Care Lung Cancer Screening and Smoking Cessation (NCT NCT04897568)

Last Updated: 2024-10-15

Results Overview

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?

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

Baseline

Results posted on

2024-10-15

Participant Flow

Unit of analysis: clinic

Participant milestones

Participant milestones
Measure	Control (Pre-intervention) The control group will consist of each participant and clinic before the intervention (baseline, first 2 months).	Patient Decision Aid (Post-intervention) The intervention group will consist of each participant and clinic once they move to the intervention phase (after the first 2 months, pre-post study 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.
Overall Study STARTED	64 3	56 3
Overall Study COMPLETED	64 3	56 3
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control (Pre-intervention) n=64 Participants The control group will consist of each participant and clinic before the intervention (baseline, first 2 months).	Patient Decision Aid (Post-intervention) n=54 Participants 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.	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	42 Participants n=7 Participants	94 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	48 Participants n=7 Participants	106 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Control n=64 Participants The control group will consist of each participant and clinic before the intervention (pre-intervention).	Patient Decision Aid n=54 Participants The intervention group will consist of each participant and clinic once they move to the intervention phase (post-intervnetion). 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.
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	0 participants

PRIMARY outcome

Timeframe: 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?

Outcome measures

Outcome measures
Measure	Control n=64 Participants The control group will consist of each participant and clinic before the intervention (pre-intervention).	Patient Decision Aid n=54 Participants The intervention group will consist of each participant and clinic once they move to the intervention phase (post-intervnetion). 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.
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	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=64 Participants The control group will consist of each participant and clinic before the intervention (pre-intervention).	Patient Decision Aid n=54 Participants The intervention group will consist of each participant and clinic once they move to the intervention phase (post-intervnetion). 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.
Patient Knowledge About Lung Cancer	8.1 score on a scale Standard Deviation 2.3	8.5 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 1 month follow up

Outcome measures

Outcome measures
Measure	Control n=64 Participants The control group will consist of each participant and clinic before the intervention (pre-intervention).	Patient Decision Aid n=54 Participants The intervention group will consist of each participant and clinic once they move to the intervention phase (post-intervnetion). 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.
Patient Knowledge About Lung Cancer	8.1 score on a scale Standard Deviation 2.3	8.5 score on a scale Standard Deviation 1.5

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dan Mattlock

University of Colorado

Phone: (303)724-9941

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place