Pilot Study of Patient Navigation to Promote Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT01414036|
Recruitment Status : Completed
First Posted : August 11, 2011
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cigarette Smoking||Other: Enhanced Traditional Care control Behavioral: Patient navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Primary Care-based Patient Navigation to Promote Smoking Cessation Treatment: a Pilot Randomized Controlled Trial|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Enhanced Traditional Care control
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
Educational brochure, list of hospital and community resources
Experimental: Patient Navigation
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
Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
- Engagement in Smoking Cessation Treatment [ Time Frame: 3 months ]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).
- Stage of Change With Regard to Smoking Cessation [ Time Frame: 3 months ]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.
- Use of Other Tobacco Treatment Support [ Time Frame: 3 months ]self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414036
|Principal Investigator:||Karen E Lasser, MD, MPH||Boston Medical Center/Boston University School of Medicine|