Smoking Cessation Following Psychiatric Hospitalization

Nicotine Dependence Clinical Trial

Official title:

Extended Care for Smoking Cessation Following Psychiatric Hospitalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204956
• Other study ID #: 1R01MH104562
• Secondary ID: 1R01MH104562
• Status: Recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: June 2019

Study information

• Verified date: May 2018
• Source: University of Texas at Austin
• Contact: Richard A Brown, Ph.D.
• Phone: 512-471-8584
• Email: brown2[@]utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 422
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Seton Shoal Creek Hospital	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incremental cost effectiveness		6 month
Other	Psychiatric symptoms		6 months
Other	Hospital readmissions, both psychiatric and medical		6 months
Other	Emergency room visits, both psychiatric and medical		6 months
Primary	Biochemically verified smoking abstinence via saliva cotinine		6 months
Secondary	Proportion of patients who use smoking cessation medication or counseling following discharge		6 months