Pilot Study of Patient Navigation to Promote Smoking Cessation

NCT ID: NCT01414036

Last Updated: 2016-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Traditional Care control

Intervention Type: OTHER

Educational brochure, list of hospital and community resources

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.

Group Type: EXPERIMENTAL

Patient navigation

Intervention Type: BEHAVIORAL

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

Interventions

Enhanced Traditional Care control

Educational brochure, list of hospital and community resources

Intervention Type: OTHER

Patient navigation

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Karen E. Lasser

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen E Lasser, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center/Boston University School of Medicine

Other Identifiers

UL1RR025771

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UL1RR025771

Identifier Type: NIH

Identifier Source: org_study_id

View Link