<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02204956</url>
  </required_header>
  <id_info>
    <org_study_id>1R01MH104562</org_study_id>
    <secondary_id>1R01MH104562</secondary_id>
    <nct_id>NCT02204956</nct_id>
  </id_info>
  <brief_title>Smoking Cessation Following Psychiatric Hospitalization</brief_title>
  <official_title>Extended Care for Smoking Cessation Following Psychiatric Hospitalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Smoking rates among individuals with psychiatric disorders are disproportionately higher than&#xD;
      the general population. The majority of psychiatric hospitals ban smoking on hospital&#xD;
      grounds, thus providing an opportunity for inpatients to experience abstinence. Yet smokers&#xD;
      in inpatient psychiatric settings are infrequently provided with referrals for cessation&#xD;
      treatment on discharge (&lt; 1 %) and most resume smoking upon discharge. Therefore, the&#xD;
      integration of effective cessation interventions within the current mental health treatment&#xD;
      system is a public health priority.&#xD;
&#xD;
      The overall objective of this project is to adapt a Sustained Care (SusC) model to smokers&#xD;
      with severe mental illness (SMI) engaged in a psychiatric hospitalization and to conduct a&#xD;
      randomized, pragmatic effectiveness trial designed to assess the benefit of this adapted SusC&#xD;
      intervention in real-world practice. We will test the hypothesis that, among smokers with SMI&#xD;
      in inpatient psychiatric treatment (n = 422), SusC will result in significantly greater rates&#xD;
      of cotinine-validated, 7-day point prevalence abstinence at 6- and 12-months compared to a&#xD;
      group that receives Usual Care (UC) about smoking cessation. Furthermore, we hypothesize that&#xD;
      a higher proportion of SusC vs. UC patients will use evidence-based smoking cessation&#xD;
      treatment (counseling and pharmacotherapy) in the month after discharge. We will also explore&#xD;
      the effect of SusC on health and health care utilization in the 12 months post-discharge&#xD;
      (psychiatric symptoms, psychiatric and medical hospital readmissions and emergency room&#xD;
      visits) and the effectiveness of SusC on smoking abstinence in patient diagnostic subgroups.&#xD;
&#xD;
      The expected outcome of this project is a demonstration of the effectiveness of a Sustained&#xD;
      Care intervention for smoking cessation in individuals with severe mental illness (SMI)&#xD;
      following psychiatric hospitalization. Future studies could extend these findings to&#xD;
      individuals with SMI receiving outpatient psychiatric treatment or psychotherapy. Overall,&#xD;
      this research would have a significant positive public health impact that will move us closer&#xD;
      to the long-term goal of dissemination and integration of the Sustained Care model to&#xD;
      increase smoking cessation and decrease smoking related morbidity and mortality in people&#xD;
      with severe mental illness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2015</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemically verified smoking abstinence via saliva cotinine</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who use smoking cessation medication or counseling following discharge</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Incremental cost effectiveness</measure>
    <time_frame>6 month</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Psychiatric symptoms</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospital readmissions, both psychiatric and medical</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Emergency room visits, both psychiatric and medical</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">422</enrollment>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>Sustained Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sustained Care</intervention_name>
    <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.</description>
    <arm_group_label>Sustained Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <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.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  current smoker (i.e., at least 5 cigarettes/day when not hospitalized)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current diagnosis of dementia&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE: [45]) score &lt; 24&#xD;
&#xD;
          -  patient's inability to provide consent for study participation due to his/her&#xD;
             inability to demonstrate an understanding of study procedures as contained in the&#xD;
             statement of informed consent, after no more than two explanations&#xD;
&#xD;
          -  current diagnosis of mental retardation or autistic disorder&#xD;
&#xD;
          -  current primary diagnosis of a (non-nicotine) substance use disorder&#xD;
&#xD;
          -  no access to a telephone or inability to communicate by telephone&#xD;
&#xD;
          -  no planned discharge to institutional setting&#xD;
&#xD;
          -  medical contraindication for the use of nicotine replacement therapy (NRT)&#xD;
&#xD;
          -  pregnancy, breastfeeding, or plans to become pregnant within 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy A. Rigotti, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard A Brown, Ph.D.</last_name>
    <phone>512-471-8584</phone>
    <email>brown2@utexas.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seton Shoal Creek Hospital</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly L Kjome, M.D.</last_name>
      <phone>512-324-2039</phone>
      <email>KLKjome@ascension.org</email>
    </contact>
    <investigator>
      <last_name>Kimberly L Kjome, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>Tobacco use cessation</keyword>
  <keyword>Psychiatric comorbidity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 27, 2021</submitted>
    <returned>October 25, 2021</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02204956
org study id: 1R01MH104562
secondary id: 1R01MH104562
nct id: NCT02204956
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Biochemically verified smoking abstinence via saliva cotinine
time frame: 6 months
measure: Proportion of patients who use smoking cessation medication or counseling following discharge
time frame: 6 months
measure: Incremental cost effectiveness
time frame: 6 month
measure: Psychiatric symptoms
time frame: 6 months
measure: Hospital readmissions, both psychiatric and medical
time frame: 6 months
measure: Emergency room visits, both psychiatric and medical
time frame: 6 months
arm group label: Sustained Care
arm group type: Experimental
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 group label: Usual Care
arm group type: Active Comparator
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: Sustained Care
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.
arm group label: Sustained Care
intervention type: Behavioral
intervention name: Usual Care
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.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nancy A. Rigotti, M.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Richard A Brown, Ph.D.
phone: 512-471-8584
email: brown2@utexas.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
sharing ipd: Undecided
submitted: September 27, 2021
returned: October 25, 2021