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| ID | Type | Description | Link |
|---|---|---|---|
| UL1RR025771 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Traditional Care control | Other | Educational brochure, list of hospital and community resources |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen E Lasser, MD, MPH | Boston Medical Center/Boston University School of Medicine | Principal Investigator |
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J Ethn Subst Abuse. 2013 ; 12(4): . doi:10.1080/15332640.2013.819311.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Received Allocated Intervention |
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| Completed 3 Month Survey |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Number | participant | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen E. Lasser | Boston Medical Center | 617-414-6688 | karen.lasser@bmc.org |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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| Patient navigation | Behavioral | Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period. |
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| 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 |
| NOT COMPLETED |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | 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. |
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| 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. | 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. | Posted | Number | participant | 3 months |
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| 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. | 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. | Posted | Number | participant | 3 months |
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| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 0 | 24 | 0 | 24 |
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| D006298 | Health Services Administration |