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OpenTrials
Completed

NCT Number: NCT02705365

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

55 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient Navigation

Other

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

Usual Care

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.

Primary outcomes

  1. Chest CT Completion

    Time frame: 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 outcomes

  1. Tobacco Treatment Use

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2016
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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