Patient Navigation for Lung Screening at MGH Community Health Centers

Lung Cancer Clinical Trial

Official title:

Patient Navigation for Lung Screening at MGH Community Health Centers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02705365
• Other study ID #: 2015P002239
• Secondary ID: CCCDAA-14-012-01
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: December 14, 2017
• Start date: February 1, 2016
• Est. completion date: February 7, 2017

Study information

• Verified date: December 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To develop and implement a patient navigator (PN) program for lung screening and smoking cessation in community health center primary care practices. This program will be evaluated in a randomized controlled trial of primary care patients who currently smoke.

Description:

The specific aims of this study are:

Specific Aim 1: To develop a patient navigator (PN) program for lung screening for patients who are current smokers, aged 55-77 years, potentially eligible for lung screening and are receiving care at community health centers (CHCs) affiliated with MGH.

Specific Aim 2: To evaluate the effectiveness of the new lung screening PN program in improving screening rates and increasing use of tobacco cessation services in a randomized controlled trial.

Specific Aim 3: To demonstrate that equity is maintained in rates of lung screening and in follow up of abnormal chest CT results, comparing eligible smokers from CHCs with eligible smokers from other practices within the MGH primary care network.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: February 7, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 77 Years

Eligibility

Inclusion Criteria:

1. adult patients aged 55-77 years who are current cigarette smokers (according to an algorithm using electronic medical record data), and

2. receive care at one of the five Massachusetts General Hospital community health centers.

Exclusion Criteria:

1. patients who have previously received a diagnosis of lung cancer,

2. have undergone a chest CT within 18 months before enrollment,

3. are subsequently identified as having died prior to the study intervention,

4. deemed by their primary care provider as not eligible for lung screening.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Other:
• Patient Navigation
One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.
• Usual Care
Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest CT Completion	Percentage of patients assigned to the intervention and control groups who had at least one chest CT (according to billing and EMR data) during the 1-year study period.	Up to 1 year
Secondary	Tobacco Treatment Use	Percentage of patients, comparing intervention and control groups, who during the 1-year study period had referral to Massachusetts Quitline, smoking cessation medication prescribed, or referral to in-person counseling.	Up to 1 year