Pilot Study of Patient Navigation to Promote Smoking Cessation

NCT01414036 | Completed Results

• 1 other identifier: UL1RR025771
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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

Keywords

cigarette smoking; patient navigation; primary care

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Stage of Change With Regard to Smoking Cessation

  3 months

• Use of Other Tobacco Treatment Support

  3 months

Study Arms (2)

Enhanced Traditional Care control

ACTIVE COMPARATOR

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

Patient Navigation

EXPERIMENTAL

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

Interventions

Enhanced Traditional Care control OTHER

Educational brochure, list of hospital and community resources

Enhanced Traditional Care control

Patient navigation BEHAVIORAL

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

Patient Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead
• National Center for Research Resources (NCRR): collaborator

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Karen E. Lasser
• Organization: Boston Medical Center

karen.lasser@bmc.org

617-414-6688

Study Officials

• Karen E Lasser, MD, MPH

  Boston Medical Center/Boston University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 11, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 21, 2016
• Results First Posted: March 21, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share