N/A
N=47
Pilot Study of Patient Navigation to Promote Smoking Cessation
Cigarette Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01414036 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Engagement in Smoking Cessation Treatment — 7; 9 participant
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Traditional Care control (Other); Patient navigation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Engagement in Smoking Cessation Treatment |
7; 9 | — |
| SECONDARY Stage of Change With Regard to Smoking Cessation |
1; 7 | — |
| SECONDARY Use of Other Tobacco Treatment Support |
6; 9 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT01414036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.