Pilot Study of Patient Navigation to Promote Smoking Cessation
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Purpose
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 | Intervention |
|---|---|
|
Cigarette Smoking |
Other: Enhanced Traditional Care control Behavioral: Patient navigation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Primary Care-based Patient Navigation to Promote Smoking Cessation Treatment: a Pilot Randomized Controlled Trial |
- engagement in smoking cessation treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Stage of change is assessed at baseline and 3 months, according to the following categories: pre-contemplation, contemplation, preparation, or action. For each participant, we compare stage of change at baseline vs. 3 months.
- Use of tobacco treatment medications [ Time Frame: 3 months ] [ Designated as safety issue: No ]self-reported use of prescribed and OTC medications.
- level of nicotine dependence [ Time Frame: 3 months ] [ Designated as safety issue: No ]Fagerstrom Test for Nicotine Dependence
- use of other tobacco treatment support [ Time Frame: 3 months ] [ Designated as safety issue: No ]self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Karen E. Lasser, Physician, Boston University |
| ClinicalTrials.gov Identifier: | NCT01414036 History of Changes |
| Other Study ID Numbers: | UL1RR025771, UL1RR025771 |
| Study First Received: | August 9, 2011 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston University:
|
cigarette smoking patient navigation primary care |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 23, 2013