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Proactive Outreach for Smokers in VA Mental Health

Proactive Outreach for Smokers in VA Mental Health

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01737281
Acronym
PROMH
Enrollment
1938
Registered
2012-11-29
Start date
2014-07-01
Completion date
2018-06-30
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

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.

BEHAVIORALUsual care

Usual smoking cessation care from VA clinical staff.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
Number of Participants With Cotinine-Validated Abstinence From Smoking12 monthsThe primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.

Secondary

MeasureTime frameDescription
Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes12 monthsAt 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

ArmCount
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
Total1,938

Baseline characteristics

CharacteristicUsual CareTotalProactive Outreach
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
323 Participants630 Participants307 Participants
Age, Categorical
Between 18 and 65 years
646 Participants1308 Participants662 Participants
Age, Continuous58.9 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 Participants13 Participants7 Participants
Race (NIH/OMB)
Asian
8 Participants14 Participants6 Participants
Race (NIH/OMB)
Black or African American
309 Participants603 Participants294 Participants
Race (NIH/OMB)
More than one race
35 Participants79 Participants44 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
5 Participants9 Participants4 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants22 Participants11 Participants
Race (NIH/OMB)
White
595 Participants1198 Participants603 Participants
Region of Enrollment
United States
969 Participants1938 Participants969 Participants
Sex: Female, Male
Female
125 Participants253 Participants128 Participants
Sex: Female, Male
Male
844 Participants1685 Participants841 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
9 / 96912 / 969
other
Total, other adverse events
0 / 9690 / 969
serious
Total, serious adverse events
39 / 96928 / 969

Outcome results

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.

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Proactive OutreachNumber of Participants With Cotinine-Validated Abstinence From Smoking36 Participants
Usual CareNumber of Participants With Cotinine-Validated Abstinence From Smoking30 Participants
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

Time frame: 12 months

Population: We used a complete case analysis, excluding participants for whom information was not available at 12 month follow-up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Proactive OutreachNumber of Participants Self-Reporting 7-Day Abstinence From Cigarettes119 Participants
Usual CareNumber of Participants Self-Reporting 7-Day Abstinence From Cigarettes96 Participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026