Pilot Study of Patient Navigation to Promote Smoking Cessation

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

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking
• Intervention / Treatment: Other: Enhanced Traditional Care control; Behavioral: Patient navigation

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage of Change With Regard to Smoking Cessation	Stage of change is assessed at baseline and 3 months. Three months after study entry, 7 of patient navigation-intervention participants who had initially said that they did not have a time frame in mind for quitting reported that they now had a time frame in mind for quitting, relative to 1 of ETC-control participants.	3 months
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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Center for Research Resources (NCRR)
• Investigators: Principal Investigator: Karen E Lasser, MD, MPH, Boston Medical Center/Boston University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Estimate): March 21, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: primary care; patient navigation; cigarette smoking
• Other Study ID Numbers: UL1RR025771 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

J Ethn Subst Abuse. 2013 ; 12(4): . doi:10.1080/15332640.2013.819311.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3827692/