Lung Cancer
Conditions
Keywords
Lung Screening, Low-Dose Computer Tomography, Patient Navigation
Brief 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.
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.
Interventions
OTHERPatient Navigation
One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.
OTHERUsual 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 77 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chest CT Completion | Up to 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco Treatment Use | Up to 1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Patient Navigation: One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance. | 400 |
| 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.
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. | 800 |
| Total | 1,200 |
Baseline characteristics
| Characteristic | Patient Navigation | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 5.4 | 62.4 years STANDARD_DEVIATION 5.7 | 62.2 years STANDARD_DEVIATION 5.6 |
| Clinic Visits Over 3 Years | 10.3 visits STANDARD_DEVIATION 7.9 | 10.7 visits STANDARD_DEVIATION 8.4 | 10.5 visits STANDARD_DEVIATION 8.3 |
| Insurance Commercial | 128 Participants | 280 Participants | 408 Participants |
| Insurance Dual Medicare/Medicaid | 103 Participants | 225 Participants | 328 Participants |
| Insurance Medicaid | 121 Participants | 211 Participants | 332 Participants |
| Insurance Medicare | 47 Participants | 84 Participants | 131 Participants |
| Insurance Self | 1 Participants | 0 Participants | 1 Participants |
| Language English | 352 Participants | 714 Participants | 1066 Participants |
| Language Non-English | 48 Participants | 86 Participants | 134 Participants |
| Race/Ethnicity, Customized Asian | 18 Participants | 22 Participants | 40 Participants |
| Race/Ethnicity, Customized Black | 18 Participants | 25 Participants | 43 Participants |
| Race/Ethnicity, Customized Hispanic | 26 Participants | 41 Participants | 67 Participants |
| Race/Ethnicity, Customized Other/Unknown | 27 Participants | 46 Participants | 73 Participants |
| Race/Ethnicity, Customized White | 311 Participants | 666 Participants | 977 Participants |
| Sex: Female, Male Female | 188 Participants | 442 Participants | 630 Participants |
| Sex: Female, Male Male | 212 Participants | 358 Participants | 570 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 400 | 0 / 800 |
| other Total, other adverse events | 0 / 400 | 0 / 800 |
| serious Total, serious adverse events | 0 / 400 | 0 / 800 |
Outcome results
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.
Time frame: Up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Navigation | Chest CT Completion | 124 Participants |
| Usual Care | Chest CT Completion | 138 Participants |
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.
Time frame: Up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Navigation | Tobacco Treatment Use | 133 Participants |
| Usual Care | Tobacco Treatment Use | 0 Participants |