Patient Navigation for Lung Screening at MGH Community Health Centers

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Patient Navigation; Other: Usual Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Navigation; Patients assigned to the patient navigator (PN) arm will be sent a letter about the program with lung screening educational materials. The PN will educate eligible patients about lung screening, explore barriers to screening, coordinate scheduling an appointment with a provider, and possibly attend the visit with the patient. The PN will further coordinate scheduling the CT scan, help the patient obtain the test, and access any required follow-up. The PN will assess the patient's interest in quitting smoking and if so, offer and help to connect the smoker to existing cessation resources in the community and provide follow-up contacts to monitor adherence to treatments.	Other: Patient Navigation; One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.
Active Comparator: Usual Care; The control group will receive usual care during the 1-year 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Sanja Percac-Lima, MD, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Percac-Lima S, Ashburner JM, Rigotti NA, Park ER, Chang Y, Kuchukhidze S, Atlas SJ. Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial. Cancer Med. 2018 Mar;7(3):894-902. doi: 10.1002/cam4.1297. Epub 2018 Feb 21.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): February 7, 2017

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Patient Navigation; Lung Screening; Low-Dose Computer Tomography
• Other Study ID Numbers: 2015P002239; CCCDAA-14-012-01-CCCDA (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO