Proactive Outreach for Smokers in VA Mental Health
PROMH
2 other identifiers
interventional
1,938
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedResults Posted
Study results publicly available
March 14, 2019
CompletedMarch 26, 2019
March 1, 2019
3 years
November 27, 2012
November 19, 2018
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes
12 months
Study Arms (2)
Proactive outreach
EXPERIMENTALProactive outreach to deliver 7 sessions of telephone counseling and nicotine replacement therapy.
Usual care
ACTIVE COMPARATORUsual smoking cessation care from clinical staff
Interventions
Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
Eligibility Criteria
You may qualify if:
- Current smoker (i.e., any tobacco use in past 30 days)
- Seen in VA Mental Health Clinic in prior 12 months
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612, United States
Minneapolis VA Health Care System, Minneapolis, MN
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
Related Publications (4)
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.
PMID: 25518878RESULTHammett 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.
PMID: 26400636RESULTRogers 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.
PMID: 29551324RESULTJapuntich 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.
PMID: 31957794DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Scott Sherman
- Organization
- VA NY Harbor Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
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
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
November 29, 2012
Study Start
July 1, 2014
Primary Completion
June 30, 2017
Study Completion
June 30, 2018
Last Updated
March 26, 2019
Results First Posted
March 14, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share