Clinical trial NCT02204956: Smoking Cessation Following Psychiatric Hospitalization
Official title: Extended Care for Smoking Cessation Following Psychiatric Hospitalization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nicotine Dependence
Keywords: Smoking cessation
Tobacco use cessation
Psychiatric comorbidity
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-07-31
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Smoking rates among individuals with psychiatric disorders are disproportionately higher than the general population. The majority of psychiatric hospitals ban smoking on hospital grounds, thus providing an opportunity for inpatients to experience abstinence. Yet smokers in inpatient psychiatric settings are infrequently provided with referrals for cessation treatment on discharge (\< 1 %) and most resume smoking upon discharge. Therefore, the integration of effective cessation interventions within the current mental health treatment system is a public health priority.

The overall objective of this project is to adapt a Sustained Care (SusC) model to smokers with severe mental illness (SMI) engaged in a psychiatric hospitalization and to conduct a randomized, pragmatic effectiveness trial designed to assess the benefit of this adapted SusC intervention in real-world practice. We will test the hypothesis that, among smokers with SMI in inpatient psychiatric treatment (n = 422), SusC will result in significantly greater rates of cotinine-validated, 7-day point prevalence abstinence at 6- and 12-months compared to a group that receives Usual Care (UC) about smoking cessation. Furthermore, we hypothesize that a higher proportion of SusC vs. UC patients will use evidence-based smoking cessation treatment (counseling and pharmacotherapy) in the month after discharge. We will also explore the effect of SusC on health and health care utilization in the 12 months post-discharge (psychiatric symptoms, psychiatric and medical hospital readmissions and emergency room visits) and the effectiveness of SusC on smoking abstinence in patient diagnostic subgroups.

The expected outcome of this project is a demonstration of the effectiveness of a Sustained Care intervention for smoking cessation in individuals with severe mental illness (SMI) following psychiatric hospitalization. Future studies could extend these findings to individuals with SMI receiving outpatient psychiatric treatment or psychotherapy. Overall, this research would have a significant positive public health impact that will move us closer to the long-term goal of dissemination and integration of the Sustained Care model to increase smoking cessation and decrease smoking related morbidity and mortality in people with severe mental illness.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* current smoker (i.e., at least 5 cigarettes/day when not hospitalized)

Exclusion Criteria:

* current diagnosis of dementia
* Mini-Mental State Examination (MMSE: \[45\]) score \< 24
* patient's inability to provide consent for study participation due to his/her inability to demonstrate an understanding of study procedures as contained in the statement of informed consent, after no more than two explanations
* current diagnosis of mental retardation or autistic disorder
* current primary diagnosis of a (non-nicotine) substance use disorder
* no access to a telephone or inability to communicate by telephone
* no planned discharge to institutional setting
* medical contraindication for the use of nicotine replacement therapy (NRT)
* pregnancy, breastfeeding, or plans to become pregnant within 6 months.

Primary outcomes:
measure: Biochemically verified smoking abstinence via saliva cotinine
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients who use smoking cessation medication or counseling following discharge
timeFrame: 6 months
Other outcomes:
measure: Incremental cost effectiveness
timeFrame: 6 month
measure: Psychiatric symptoms
timeFrame: 6 months
measure: Hospital readmissions, both psychiatric and medical
timeFrame: 6 months
measure: Emergency room visits, both psychiatric and medical
timeFrame: 6 months
Locations:
city: Austin
country: United States
facility: Seton Shoal Creek Hospital
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A. Rigotti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown RA, Minami H, Hecht J, Kahler CW, Price LH, Kjome KL, Bloom EL, Levy DE, Carpenter KM, Smith A, Smits JAJ, Rigotti NA. Sustained Care Smoking Cessation Intervention for Individuals Hospitalized for Psychiatric Disorders: The Helping HAND 3 Randomized Clinical Trial. JAMA Psychiatry. 2021 Aug 1;78(8):839-847. doi: 10.1001/jamapsychiatry.2021.0707.