search
Back to results

Smoking Cessation Following Psychiatric Hospitalization

Primary Purpose

Nicotine Dependence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sustained Care
Usual Care
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nicotine Dependence focused on measuring Smoking cessation, Tobacco use cessation, Psychiatric comorbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seton Shoal Creek HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sustained Care

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Biochemically verified smoking abstinence via saliva cotinine

Secondary Outcome Measures

Proportion of patients who use smoking cessation medication or counseling following discharge

Full Information

First Posted
July 28, 2014
Last Updated
May 3, 2018
Sponsor
University of Texas at Austin
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT02204956
Brief Title
Smoking Cessation Following Psychiatric Hospitalization
Official Title
Extended Care for Smoking Cessation Following Psychiatric Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Smoking cessation, Tobacco use cessation, Psychiatric comorbidity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
422 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sustained Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sustained Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
Biochemically verified smoking abstinence via saliva cotinine
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of patients who use smoking cessation medication or counseling following discharge
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Incremental cost effectiveness
Time Frame
6 month
Title
Psychiatric symptoms
Time Frame
6 months
Title
Hospital readmissions, both psychiatric and medical
Time Frame
6 months
Title
Emergency room visits, both psychiatric and medical
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard A Brown, Ph.D.
Phone
512-471-8584
Email
brown2@utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A. Rigotti, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seton Shoal Creek Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly L Kjome, M.D.
Phone
512-324-2039
Email
KLKjome@ascension.org
First Name & Middle Initial & Last Name & Degree
Kimberly L Kjome, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33950156
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. Erratum In: JAMA Psychiatry. 2021 Aug 1;78(8):926. JAMA Psychiatry. 2022 Jan 1;79(1):87.
Results Reference
derived

Learn more about this trial

Smoking Cessation Following Psychiatric Hospitalization

We'll reach out to this number within 24 hrs