Smoking
Conditions
Keywords
Smoking, Tobacco control, Counseling, mental health
Brief summary
Veterans with a mental health diagnosis have higher a prevalence of smoking and higher rates of smoking-related morbidities compared to the general Veteran population. Smoking cessation treatment delivery in the VA typically depends on a visit from a health care provider. In this study, investigators will use information within the electronic medical record to identify all smokers with a mental health diagnosis at a VA health care facility and proactively reach out to enroll them in an intensive tobacco cessation treatment program. This approach could be generalized to other behaviors and provides a novel method to improve the health of an entire population of patients.
Detailed description
Background: Tobacco use is the leading preventable cause of death in the United States and contributes up to 24% of all VA healthcare costs. Veterans enrolled in the VA healthcare system smoke substantially more than the general population, which is particularly true among Veterans diagnosed with mental illness. Patients with bipolar disorder or schizophrenia have the highest smoking rates (69% and 58-90%, respectively) followed by those with PTSD (45-63%) and depression (31-51%). Numerous barriers exist for tobacco cessation among mental health patients, including high nicotine dependency, low rates of follow through for referrals, and limited availability of tobacco treatment tailored to their needs. Rationale: Most medical care providers assess tobacco use and advise smokers to quit, but they have insufficient time to follow up with treatment, leading to low long-term quit rates. Mental health providers who often meet regularly with patients report that they find tobacco cessation outside the scope of their practice and neither assess tobacco use nor refer smokers for treatment. These practice patterns have been very difficult to change even with intensive methods and across various settings and provider types. Therefore, the investigators here propose to use the electronic medical record system to identify smokers receiving mental health care and proactively reach out to engage them in treatment in line with the following aims: Specific Aims: 1. Compare the reach and efficacy of a proactive outreach telephone-based tobacco cessation (PRO) program for patients seen in mental health to usual care (UC) advice and referral to local VA and community tobacco cessation resources. 2. Model longitudinal associations between baseline sociodemographic, medical and mental health characteristics and abstinence at 6 and 12 months in the PRO and UC conditions. Methods: Investigators will use the electronic medical record to identify N=6,400 patients across 4 VA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past year and who have had a mental health visit in the past 6 months. Investigators will send each patient an introductory letter and baseline survey. Respondents will be randomized in a 1:1 fashion to intervention or control. Control participants will receive VA usual care. Intervention participants will receive proactive telephone counseling and cessation medications. Investigators will assess tobacco use at 6 and 12 months from enrollment. The primary outcome is cotinine-validated abstinence at the 12-month follow-up.
Interventions
Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
Usual smoking cessation care from VA clinical staff.
Sponsors
Study design
Eligibility
Inclusion criteria
* Current smoker (i.e., any tobacco use in past 30 days) * Seen in VA Mental Health Clinic in prior 12 months
Exclusion criteria
* Dementia * Does not speak English * Does not have a telephone and mailing address (necessary to mail out consent materials and to deliver the telephone-based intervention)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cotinine-Validated Abstinence From Smoking | 12 months | The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes | 12 months | At 12 month follow-up, participants were asked if the had smoked any cigarettes in the last 7 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proactive Outreach Intervention arm participants received: (1) 12 sessions of proactive telephone cessation counseling, (2) coordination of cessation medications from a VA provider, (3) mailed stress reduction materials, (4) engagement of their regular mental health provider in the treatment process through CPRS progress notes, to which their provider will be added as signer. | 969 |
| Usual Care Control arm participants received a mailed list of local VA and non-VA smoking cessation services that they can access on their own. In addition, patients randomized to the control group received treatment or referrals to treatment from their regular VA providers as part of usual care. Pharmacotherapy is available at all sites in the form of nicotine replacement (patches, gum and lozenges) and bupropion. | 969 |
| Total | 1,938 |
Baseline characteristics
| Characteristic | Usual Care | Total | Proactive Outreach |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 323 Participants | 630 Participants | 307 Participants |
| Age, Categorical Between 18 and 65 years | 646 Participants | 1308 Participants | 662 Participants |
| Age, Continuous | 58.9 years STANDARD_DEVIATION 11.3 | 58.6 years STANDARD_DEVIATION 11.4 | 58.3 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 309 Participants | 603 Participants | 294 Participants |
| Race (NIH/OMB) More than one race | 35 Participants | 79 Participants | 44 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 22 Participants | 11 Participants |
| Race (NIH/OMB) White | 595 Participants | 1198 Participants | 603 Participants |
| Region of Enrollment United States | 969 Participants | 1938 Participants | 969 Participants |
| Sex: Female, Male Female | 125 Participants | 253 Participants | 128 Participants |
| Sex: Female, Male Male | 844 Participants | 1685 Participants | 841 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 969 | 12 / 969 |
| other Total, other adverse events | 0 / 969 | 0 / 969 |
| serious Total, serious adverse events | 39 / 969 | 28 / 969 |
Outcome results
Number of Participants With Cotinine-Validated Abstinence From Smoking
The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.
Time frame: 12 months
Population: Cotinine samples were obtained by mail from 53/76 people reporting abstinence in the intervention arm and 44/58 people reporting abstinence in the control arm. Note that this reflects a complete case analysis, only including people for whom outcome data are available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proactive Outreach | Number of Participants With Cotinine-Validated Abstinence From Smoking | 36 Participants |
| Usual Care | Number of Participants With Cotinine-Validated Abstinence From Smoking | 30 Participants |
Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes
At 12 month follow-up, participants were asked if the had smoked any cigarettes in the last 7 days
Time frame: 12 months
Population: We used a complete case analysis, excluding participants for whom information was not available at 12 month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proactive Outreach | Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes | 119 Participants |
| Usual Care | Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes | 96 Participants |