Patient Navigation for Lung Screening at MGH Community Health Centers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Patient Navigation for Lung Screening at MGH Community Health Centers

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Patient Navigation
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients aged 55-77 years who are current cigarette smokers (according to an algorithm using electronic medical record data), and receive care at one of the five Massachusetts General Hospital community health centers. Exclusion Criteria: patients who have previously received a diagnosis of lung cancer, have undergone a chest CT within 18 months before enrollment, are subsequently identified as having died prior to the study intervention, deemed by their primary care provider as not eligible for lung screening.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Navigation<br>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<br>* One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.<br>|
| Active Comparator: Usual Care<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Screening, Low-Dose Computer Tomography, Patient Navigation