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Smoking Cessation Following Psychiatric Hospitalization

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ClinicalTrials.gov Identifier: NCT02204956
Recruitment Status : Recruiting
First Posted : July 31, 2014
Last Update Posted : May 10, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Texas at Austin

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.


Condition or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: Sustained Care Behavioral: Usual Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Extended Care for Smoking Cessation Following Psychiatric Hospitalization
Study Start Date : July 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sustained Care
A 40-minute, in-hospital motivational counseling session about smoking cessation, 8 Interactive Voice Response (IVR) phone calls and/or texts over 90 days, including the possibility of a warm transfer to a telephone tobacco quit line and up to 8-weeks of free transdermal nicotine patches.
Behavioral: Sustained Care
The Sustained Care intervention includes four main components: 1. a 40-minute individual session about quitting smoking during the hospital stay; 2. a 90-day telephone-based and text messaging program that provides support regarding smoking and nicotine patch use; 3. the opportunity, during the automated calls and texts to be transferred to quit smoking resources, including live telephone quit coaching counseling, web and text-based quit coaching resources; and 4. an 8-week supply of nicotine patches, provided at no cost.

Active Comparator: Usual Care
A brief 5-10 minute tobacco education session that all hospitalized smokers will receive, delivered by a hospital nurse. During this session, they will be provided with written handouts describing the stages of readiness for change in quitting, self-monitoring of smoking, self-management of smoking situations, relapse prevention, managing stress, other quitting tips and use of nicotine replacement therapy.
Behavioral: Usual Care
Usual Care includes a brief, 5 - 10 minute education session about quitting smoking, delivered by a hospital nurse during the hospital stay. Written handouts to reinforce the educational session will also be provided.




Primary Outcome Measures :
  1. Biochemically verified smoking abstinence via saliva cotinine [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Proportion of patients who use smoking cessation medication or counseling following discharge [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Incremental cost effectiveness [ Time Frame: 6 month ]
  2. Psychiatric symptoms [ Time Frame: 6 months ]
  3. Hospital readmissions, both psychiatric and medical [ Time Frame: 6 months ]
  4. Emergency room visits, both psychiatric and medical [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204956


Contacts
Contact: Richard A Brown, Ph.D. 512-471-8584 brown2@utexas.edu

Locations
United States, Texas
Seton Shoal Creek Hospital Recruiting
Austin, Texas, United States, 78731
Contact: Kimberly L Kjome, M.D.    512-324-2039    KLKjome@ascension.org   
Principal Investigator: Kimberly L Kjome, M.D.         
Sponsors and Collaborators
University of Texas at Austin
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Nancy A. Rigotti, M.D. Massachusetts General Hospital

Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02204956     History of Changes
Other Study ID Numbers: 1R01MH104562 ( U.S. NIH Grant/Contract )
1R01MH104562 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Texas at Austin:
Smoking cessation
Tobacco use cessation
Psychiatric comorbidity

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action