Cigarette Smoking Clinical Trial
Official title:
Primary Care-based Patient Navigation to Promote Smoking Cessation Treatment: a Pilot Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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