Cigarette Smoking
Conditions
Keywords
cigarette smoking, patient navigation, primary care
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.
Interventions
Educational brochure, list of hospital and community resources
BEHAVIORALPatient navigation
Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
Sponsors
National Center for Research Resources (NCRR)
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Smoking Cessation Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Stage of Change With Regard to Smoking Cessation | 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. |
| Use of Other Tobacco Treatment Support | 3 months | self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Enhanced Traditional Care control: Educational brochure, list of hospital and community resources | 23 |
| 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.
Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period. | 24 |
| Total | 47 |
Baseline characteristics
| Characteristic | Enhanced Traditional Care Control | Patient Navigation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
Primary
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).
Time frame: 3 months
Population: 14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Traditional Care Control | Engagement in Smoking Cessation Treatment | 7 participant |
| Patient Navigation | Engagement in Smoking Cessation Treatment | 9 participant |
Secondary
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.
Time frame: 3 months
Population: 14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Traditional Care Control | Stage of Change With Regard to Smoking Cessation | 1 participant |
| Patient Navigation | Stage of Change With Regard to Smoking Cessation | 7 participant |
Secondary
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.
Time frame: 3 months
Population: 14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Traditional Care Control | Use of Other Tobacco Treatment Support | 6 participant |
| Patient Navigation | Use of Other Tobacco Treatment Support | 9 participant |