Nicotine DependenceNCT02204956
Smoking Cessation Following Psychiatric Hospitalization
A study testing Sustained Care in people with Nicotine Dependence, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Sustained Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- current smoker (i.e., at least 5 cigarettes/day when not hospitalized)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seton Shoal Creek Hospital
Austin, Texas, 78731
Kimberly L Kjome, M.D., 512-324-2039, KLKjome@ascension.org
Kimberly L Kjome, M.D.
About this study
Official title: Extended Care for Smoking Cessation Following Psychiatric Hospitalization
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.
- Conditions
- Nicotine Dependence
- Being tested
- Sustained Care, Usual Care
- Keywords
- Smoking cessation, Tobacco use cessation, Psychiatric comorbidity
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained CareBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sustained Care | Experimental | 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. Receives: Behavioral: Sustained Care |
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically verified smoking abstinence via saliva cotinine
Measured: 6 months
Secondary outcomes (1)
Proportion of patients who use smoking cessation medication or counseling following discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJul 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Nancy A. Rigotti, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204956
- Sponsor's protocol ID
- 1R01MH104562
- Other IDs
- 1R01MH104562
- Status last verified
- May 2018
- First submitted
- 28 Jul 2014
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33950156
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Care for Smoking Cessation Following Psychiatric Hospitalization
- ClinicalTrials.gov ID
- NCT02204956
- Acronym / sponsor ID
- 1R01MH104562
- Conditions
- Nicotine Dependence
- Keywords
- Smoking cessation, Tobacco use cessation, Psychiatric comorbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sustained Care | Experimental | Behavioral: Sustained CareA 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. |
| Usual Care | Active comparator | Behavioral: Usual CareA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- current smoker (i.e., at least 5 cigarettes/day when not hospitalized)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sustained CareThe 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. | Behavioural | Sustained Care |
| Usual CareUsual 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. | Behavioural | Usual Care |
Primary outcome
Biochemically verified smoking abstinence via saliva cotinine
Time frame: 6 months
1 secondary outcome
Proportion of patients who use smoking cessation medication or counseling following discharge
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Derived from this study: PubMed 33950156Brown 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A. Rigotti, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained Care in people with Nicotine Dependence, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard A Brown, Ph.D. (512-471-8584, brown2@utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically verified smoking abstinence via saliva cotinine (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02204956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.