SmokingPROMHNCT01737281
Proactive Outreach for Smokers in VA Mental Health
A study testing Proactive outreach in people with Smoking, run by VA Office of Research and Development at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Proactive outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,938 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2014to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current smoker (i.e., any tobacco use in past 30 days)
- Seen in VA Mental Health Clinic in prior 12 months
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
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.
Read the 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:
- 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.
- 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.
- Conditions
- Smoking
- Being tested
- Proactive outreach, Usual care
- Keywords
- Smoking, Tobacco control, Counseling, mental health
- Medical subject headings
- Smoking, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive outreachBehavioural
Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
Usual careBehavioural
Usual smoking cessation care from VA clinical staff.
| Study group | Role | What they receive |
|---|---|---|
| Proactive outreach | Experimental | Proactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy. Receives: Behavioral: Proactive outreach |
| Usual care | Active comparator | Usual smoking cessation care from clinical staff Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Cotinine-Validated Abstinence From Smoking
The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study start1 Jul 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,938 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott E Sherman, MD MPH, Principal investigator, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NYSteven S. Fu, MD MSCE, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737281
- Sponsor's protocol ID
- IIR 11-291
- Other IDs
- 1I01HX000817-01A2
- Acronym
- PROMH
- Status last verified
- Mar 2019
- First submitted
- 27 Nov 2012
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25518878Hammett 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.
PubMed 26400636Rogers 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.
PubMed 29551324Japuntich 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.
PubMed 31957794
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Outreach for Smokers in VA Mental Health
- ClinicalTrials.gov ID
- NCT01737281
- Acronym / sponsor ID
- PROMH / IIR 11-291
- Conditions
- Smoking
- Keywords
- Smoking, Tobacco control, Counseling, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,938 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 14 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive outreach | Experimental | Behavioral: Proactive outreachProactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy. |
| Usual care | Active comparator | Behavioral: Usual careUsual smoking cessation care from clinical staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current smoker (i.e., any tobacco use in past 30 days)
- Seen in VA Mental Health Clinic in prior 12 months
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive outreachProactive contact (mail and phone) offering smoking cessation medications and telephone counseling. | Behavioural | Proactive outreach |
| Usual careUsual smoking cessation care from VA clinical staff. | Behavioural | Usual care |
Primary outcome
Number of Participants With Cotinine-Validated Abstinence From Smoking
Time frame: 12 months
The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.
1 secondary outcome
Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25518878Rogers 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.
- Results publication: PubMed 26400636Hammett 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.
- Results publication: PubMed 29551324Rogers 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.
- Derived from this study: PubMed 31957794Japuntich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott E Sherman, MD MPH principal investigator
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
Steven S. Fu, MD MSCE principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive outreach in people with Smoking, run by VA Office of Research and Development at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Cotinine-Validated Abstinence From Smoking (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01737281, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.