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OpenTrials
Completed

NCT Number: NCT01414036

Pilot Study of Patient Navigation to Promote Smoking Cessation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Enhanced Traditional Care control

Other

Educational brochure, list of hospital and community resources

Patient Navigation

Behavioral

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

Primary outcomes

  1. Engagement in Smoking Cessation Treatment

    Time frame: 3 months

    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 outcomes

  1. Stage of Change With Regard to Smoking Cessation

    Time frame: 3 months

    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.

  2. Use of Other Tobacco Treatment Support

    Time frame: 3 months

    self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2011
Registry last updated
Mar 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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