Patient Navigation for Lung Screening at MGH Community Health Centers

NCT ID: NCT02705365

Last Updated: 2018-01-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-02-07

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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Patient Navigation

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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.

Interventions

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Patient Navigation

One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sanja Percac-Lima, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sanja Percac-Lima, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29464877 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CCCDAA-14-012-01-CCCDA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2015P002239

Identifier Type: -

Identifier Source: org_study_id

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