Pilot Study of Patient Navigation to Promote Smoking Cessation

Study Overview
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Brief Summary
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Cigarette smoking is a highly significant health threat, responsible for more than 430,000 deaths each year. Low-income persons and racial/ethnic minorities are at particularly high risk, smoking at greater rates and having greater tobacco-related morbidity and mortality than other persons. Yet poor and minority smokers are less likely to receive advice to stop smoking or to use tobacco cessation services. Using non-physician members of the health care team as patient navigators to connect low-income and minority smokers to evidence-based tobacco treatment services is a promising approach because 1) many primary care providers (PCPs) are unable to provide counseling to patients who smoke due to time constraints; 2) minority patients may be less aware of smoking cessation resources and may have misconceptions about tobacco dependence treatments; and 3) as primary care practices are redesigned as medical homes, non-physician members of the health care team will increasingly be taking on tasks previously performed by PCPs. Patient navigators are lay persons from the community, working as paid employees, who are trained to guide patients through the health care system to receive services. Information on the efficacy of patient navigation to connect vulnerable patients to smoking cessation services is needed. The investigators will implement a patient navigation-based intervention in the primary care setting to promote engagement of low-income and minority patients in smoking cessation treatment. To test our intervention, the investigators will conduct a pilot randomized control trial (RCT), randomizing 240 patients to the intervention condition (patient navigation) or an enhanced traditional care (ETC) control condition. The investigators will perform follow-up at three months following the start of the intervention, with a primary outcome of engagement in smoking cessation treatment.

Official Title
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Primary Care-based Patient Navigation to Promote Smoking Cessation Treatment: a Pilot Randomized Controlled Trial

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Other: Enhanced Traditional Care control
* Behavioral: Patient navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years smoked cigarettes in the past week have a scheduled visit with a PCP telephone access English speaking able and willing to participate in the study protocol and provide informed consent. Exclusion Criteria: planning to move out of the area within the next 6 months cognitive impairments that preclude participation in study activities. severe illness or distress inability to read/understand English actively using evidence-based smoking cessation treatment, and transient residence or lack of a telephone for follow-up assessments.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Traditional Care control<br>This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care. | Other: Enhanced Traditional Care control<br>* Educational brochure, list of hospital and community resources<br>|
| Experimental: Patient Navigation<br>Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period. | Behavioral: Patient navigation<br>* Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in Smoking Cessation Treatment | This is a dichotomous variable, Y/N, based on a) completion of > 1 quit line counseling session (based on self-report) OR b) > 1 PCP visit in which smoking cessation treatment is discussed (patient self-report and medical record review of progress notes) OR c) Completion of > 1 session of a BMC smoking cessation group (medical record review). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage of Change With Regard to Smoking Cessation | Stage of change is assessed at baseline and 3 months. Three months after study entry, 7 of patient navigation-intervention participants who had initially said that they did not have a time frame in mind for quitting reported that they now had a time frame in mind for quitting, relative to 1 of ETC-control participants. | 3 months | 
| Use of Other Tobacco Treatment Support | self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarette smoking, patient navigation, primary care