Clinical trial NCT01414036: Pilot Study of Patient Navigation to Promote Smoking Cessation
Official title: Primary Care-based Patient Navigation to Promote Smoking Cessation Treatment: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: cigarette smoking
patient navigation
primary care
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2011-08-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. age \> 18 years
2. smoked cigarettes in the past week
3. have a scheduled visit with a PCP
4. telephone access
5. English speaking
6. able and willing to participate in the study protocol and provide informed consent.

Exclusion Criteria:

1. planning to move out of the area within the next 6 months
2. cognitive impairments that preclude participation in study activities.
3. severe illness or distress
4. inability to read/understand English
5. actively using evidence-based smoking cessation treatment, and
6. transient residence or lack of a telephone for follow-up assessments.

Primary outcomes:
measure: Engagement in Smoking Cessation Treatment
timeFrame: 3 months
Secondary outcomes:
measure: Stage of Change With Regard to Smoking Cessation
timeFrame: 3 months
measure: Use of Other Tobacco Treatment Support
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston Medical Center/Boston University School of Medicine
name: Karen E Lasser, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: