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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01HX000817-01A2 | U.S. NIH Grant/Contract | View source |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proactive outreach | Experimental | Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy. |
|
| Usual care | Active Comparator | Usual smoking cessation care from clinical staff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive outreach | Behavioral | Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cotinine-Validated Abstinence From Smoking | The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott E Sherman, MD MPH | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | Principal Investigator |
| Steven S. Fu, MD MSCE | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States | ||
| Minneapolis VA Health Care System, Minneapolis, MN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25518878 | Result | Rogers ES, Fu SS, Krebs P, Noorbaloochi S, Nugent SM, Rao R, Schlede C, Sherman SE. Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial. BMC Public Health. 2014 Dec 17;14:1294. doi: 10.1186/1471-2458-14-1294. | |
| 26400636 | Result | Hammett P, Fu SS, Lando HA, Owen G, Okuyemi KS. The association of military discharge variables with smoking status among homeless Veterans. Prev Med. 2015 Dec;81:275-80. doi: 10.1016/j.ypmed.2015.09.007. Epub 2015 Sep 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proactive Outreach | Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy. Proactive outreach: Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling. |
| FG001 | Usual Care | Usual smoking cessation care from clinical staff Usual care: Usual smoking cessation care from VA clinical staff. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With Cotinine-Validated Abstinence From Smoking | The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up. | 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. | Posted | Count of Participants | Participants | 12 months |
|
Total adverse events were based on the results form 12 month follow-up
Standard adverse even definitions were used
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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 | Intervention Arm | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Sherman | VA NY Harbor Healthcare System | 212-686-7500 | 7386 | scott.sherman@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2015 | Oct 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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| Usual care | Behavioral | Usual smoking cessation care from VA clinical staff. |
|
| Minneapolis |
| Minnesota |
| 55417 |
| United States |
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010 | United States |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
| 29551324 | Result | Rogers ES, Fu SS, Krebs P, Noorbaloochi S, Nugent SM, Gravely A, Sherman SE. Proactive Tobacco Treatment for Smokers Using Veterans Administration Mental Health Clinics. Am J Prev Med. 2018 May;54(5):620-629. doi: 10.1016/j.amepre.2018.02.011. Epub 2018 Mar 15. |
| 31957794 | Derived | Japuntich SJ, Hammett PJ, Rogers ES, Fu S, Burgess DJ, El Shahawy O, Melzer AC, Noorbaloochi S, Krebs P, Sherman SE. Effectiveness of Proactive Tobacco Cessation Treatment Outreach Among Smokers With Serious Mental Illness. Nicotine Tob Res. 2020 Aug 24;22(9):1433-1438. doi: 10.1093/ntr/ntaa013. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | 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 | We used a "complete case" analysis, excluding participants for whom information was not available at 12 month follow-up | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 9 |
| 969 |
| 39 |
| 969 |
| 0 |
| 969 |
| EG001 | Control Arm | 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. | 12 | 969 | 28 | 969 | 0 | 969 |
| Life-threating event | General disorders | Non-systematic Assessment |
|
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