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Clinical Trials/NCT02204956
NCT02204956
Unknown
Not Applicable

Extended Care for Smoking Cessation Following Psychiatric Hospitalization

University of Texas at Austin1 site in 1 country422 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nicotine Dependence
Sponsor
University of Texas at Austin
Enrollment
422
Locations
1
Primary Endpoint
Biochemically verified smoking abstinence via saliva cotinine
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
June 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Biochemically verified smoking abstinence via saliva cotinine

Time Frame: 6 months

Secondary Outcomes

  • Proportion of patients who use smoking cessation medication or counseling following discharge(6 months)

Study Sites (1)

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