Pilot Study of Patient Navigation to Promote Smoking Cessation

Cigarette Smoking Clinical Trial

Official title:

Primary Care-based Patient Navigation to Promote Smoking Cessation Treatment: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414036
• Other study ID #: UL1RR025771
• Secondary ID: UL1RR025771
• Status: Completed
• Phase: N/A
• First received: August 9, 2011
• Last updated: January 20, 2016
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2016
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Other:
• Enhanced Traditional Care control
Educational brochure, list of hospital and community resources

Behavioral:
• Patient navigation
Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Center for Research Resources (NCRR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	engagement in smoking cessation treatment	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).	3 months	No
Secondary	Stage of change with regard to smoking cessation	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.	3 months	No
Secondary	Use of tobacco treatment medications	self-reported use of prescribed and OTC medications.	3 months	No
Secondary	level of nicotine dependence	Fagerstrom Test for Nicotine Dependence	3 months	No
Secondary	use of other tobacco treatment support	self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.	3 months	No