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Pilot Study of Patient Navigation to Promote Smoking Cessation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Boston University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Karen E. Lasser, Boston University
ClinicalTrials.gov Identifier:
NCT01414036
First received: August 9, 2011
Last updated: August 1, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01414036

Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Karen E Lasser, MD, MPH Boston Medical Center/Boston University School of Medicine
  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

ClinicalTrials.gov processed this record on November 27, 2014