Trial Outcomes & Findings for Patient Navigation for Lung Screening at MGH Community Health Centers (NCT NCT02705365)
NCT ID: NCT02705365
Last Updated: 2018-01-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1200 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2018-01-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
400
|
800
|
|
Overall Study
COMPLETED
|
400
|
800
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Navigation for Lung Screening at MGH Community Health Centers
Baseline characteristics by cohort
| Measure |
Patient Navigation
n=400 Participants
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.
|
Usual Care
n=800 Participants
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.
|
Total
n=1200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
188 Participants
n=5 Participants
|
442 Participants
n=7 Participants
|
630 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=5 Participants
|
358 Participants
n=7 Participants
|
570 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
26 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
27 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
311 Participants
n=5 Participants
|
666 Participants
n=7 Participants
|
977 Participants
n=5 Participants
|
|
Language
English
|
352 Participants
n=5 Participants
|
714 Participants
n=7 Participants
|
1066 Participants
n=5 Participants
|
|
Language
Non-English
|
48 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Insurance
Commercial
|
128 Participants
n=5 Participants
|
280 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
|
Insurance
Medicare
|
47 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Insurance
Medicaid
|
121 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Insurance
Dual Medicare/Medicaid
|
103 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
328 Participants
n=5 Participants
|
|
Insurance
Self
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Clinic Visits Over 3 Years
|
10.3 visits
STANDARD_DEVIATION 7.9 • n=5 Participants
|
10.7 visits
STANDARD_DEVIATION 8.4 • n=7 Participants
|
10.5 visits
STANDARD_DEVIATION 8.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPercentage 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.
Outcome measures
| Measure |
Patient Navigation
n=400 Participants
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.
|
Usual Care
n=800 Participants
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.
|
|---|---|---|
|
Chest CT Completion
|
124 Participants
|
138 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPercentage 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.
Outcome measures
| Measure |
Patient Navigation
n=400 Participants
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.
|
Usual Care
n=800 Participants
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.
|
|---|---|---|
|
Tobacco Treatment Use
|
133 Participants
|
0 Participants
|
Adverse Events
Patient Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sanja Percac-Lima, MD, PhD
Massachusetts General Hospital
Phone: 617-643-6980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place