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

NCT04897568 | Completed Results

• 3 other identifiers: 19-1706.ccP50CA244688NCI-2021-04394
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• 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?

  Baseline

• 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?

  1 month follow-up

Secondary Outcomes (2)

• Patient Knowledge About Lung Cancer

  Baseline

• Patient Knowledge About Lung Cancer

  1 month follow up

Study Arms (2)

Control

NO INTERVENTION

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

Patient decision aid

ACTIVE COMPARATOR

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

Other: Patient decision aid

Interventions

Patient decision aid OTHER

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.

Also known as: Informational flyer

Patient decision aid

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• High Plains Research Network: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Smoking Cessation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior

Results Point of Contact

• Title: Dan Mattlock
• Organization: University of Colorado

daniel.matlock@cuanschutz.edu

(303)724-9941

Study Officials

• Russell Glasgow, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: May 21, 2021
• Study Start: July 15, 2020
• Primary Completion: April 30, 2023
• Study Completion: November 29, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)