Nicotine DependenceNCT02849652
Testing an Organizational Change Model to Address Smoking in Mental Healthcare
A study testing ATTOC Intervention and UC Intervention in people with Nicotine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000, the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times greater than in the general population. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- ATTOC Intervention and UC Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 832 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a client at a participating community mental health clinic
- Must be 18 years of age or older
- Must report daily average smoking of 5 cigarettes/day for the past 6 months
- Must have a documented Diagnostic and Statistical Manual Axis I or II disorder
- Must demonstrate the ability to communicate in English and provide written informed consent
- Must be 18 years of age or older
- Must perform clinical care or supervisory duties
- Must demonstrate the ability to communicate in English and provide written informed consent
Who cannot join
- Exclusive use of electronic cigarettes (dual use with standard cigarettes will not be exclusionary)
- no clinical responsibilities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000, the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times greater than in the general population. Further, even the recent small decline in smoking rates that has been reported in the general population in the past decade has not occurred among smokers with an SMI. In fact, 44% of all the cigarettes consumed in the US are by individuals with a psychiatric disorder and the primary cause of death among Americans with an SMI is a tobacco-related disease.
This cluster randomized trial will be conducted in 14 Philadelphia community mental health clinics (CMHCs). Clinics will be randomized to either Addressing Tobacco Through Organizational Change model (ATTOC) or Usual Care (UC) treatment groups. The investigators hypothesize that 1) at the end of the intervention and at a 3-month follow-up, rates of adherence to guidelines for treating TUD will be greater among clinic personnel that receive the ATTOC intervention vs. clinic personnel in usual care; 2) at the end of the intervention and at a 3-month follow-up, rates of client smoking cessation will be significantly greater in clinics that receive the ATTOC intervention than among clients treated with usual care; and 3) using non-inferiority testing, at the end of the intervention and at a 3-month follow-up, there will be no significant degradation in mental health functioning or QOL among clients who receive care at clinics that received the ATTOC intervention than among clients treated with usual care.
Read the detailed description
Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000, the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times greater than in the general population. Transforming the mental healthcare system to integrate and adhere to evidence-based guidelines for the provision of tobacco use disorder (TUD) treatment is a priority of the National Institute of Mental Health and is a critical component of a national effort to meet Healthy People 2020 target goals for tobacco use (www.healthypeople.gov).
The Addressing Tobacco Through Organizational Change (ATTOC) model is a systems-level intervention to address systemic and cultural barriers that undermine assessment and treatment of TUD. In this innovative way, ATTOC assumes that effective organizational change requires more than clinic personnel training; it also requires the application of organizational theory to address attitudinal and system barriers and promote a culture in which tobacco use is not accepted or supported and that TUD treatment is integrated into standard practice. Consistent with organizational theory, ATTOC is implemented in 3 phases: preparing for, implementing, and sustaining change. By addressing cultural barriers and strengthening the care system (e.g., integrated treatment), ATTOC intends to have sustained benefits beyond the intervention.
This cluster-randomized trial will be conducted with 14 Philadelphia CMHCs, 7 randomized to ATTOC and 7 to usual care (UC). Following randomization, study staff will visit sites to recruit clinic personnel and clients over a 4 to 6 week period. Those eligible will complete informed consent and HIPAA forms and a baseline assessment to establish pre-intervention levels on all measures (baseline). After 4-6 weeks, the ATTOC intervention will be implemented over 9 months, from Week 1 to Week 36 (with UC at the control sites). Two mid-intervention assessments (Weeks 12 and 24) will allow for performance feedback and mediational analyses. Week 36 (end-of-treatment; EOT) and 52 (3-months post-EOT) assessments will allow for evaluation of changes on outcomes between groups over time. All measures will be conducted at the respective CMHC (or over the phone if necessary) and 7-day point prevalence smoking cessation will be verified using a breath carbon monoxide (CO) monitor (abstinence = < 8ppm).
This will be the first controlled, randomized trial to evaluate the effects of the ATTOC model on clinician adherence to treatment guidelines, client smoking, and client mental health and QOL. If this approach is shown to be effective and safe, it can serve as a model for the nation's community mental healthcare infrastructure, representing a powerful initiative to address tobacco use in an under-served sub-group of smokers, and support efforts to attain the Healthy People 2020 goals regarding tobacco use.
- Conditions
- Nicotine Dependence
- Being tested
- ATTOC Intervention, UC Intervention
- Keywords
- Smoking cessation, Nicotine dependence, Organizational change, Mental Healthcare
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTOC InterventionBehavioural
ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
UC InterventionBehavioural
Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| ATTOC | Experimental | Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence Receives: Behavioral: ATTOC Intervention |
| Usual Care | Other | Usual Care is the typical guideline based smoking cessation intervention Receives: Behavioral: UC Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Reported Tobacco Medications
Client-reported use of tobacco treatment for nicotine dependence measured via self-report
Measured: Week 36 & Week 52
Rate of Medication to Treat Nicotine Dependence - EHR
Frequency of provision of medications for nicotine dependence measured via electronic health record (EHR) data for clients.
Measured: Week 36 & Week 52
Secondary outcomes (4)
Smoking Cessation Rate
Change in proportion of smoking from baseline to follow-up time-points for clients
Measured: Week 36 & Week 52
Mental Health Functioning
Mental health functioning was measured using the Revised Behavior and Symptom Identification Scale (BASIS-R), a 24-item assessment of mental health functioning that yields a total score and subscale scores for: depression, interpersonal relationships, self-harm, emotional liability, psychosis, and substance abuse. The total overall score was used. The 24 questions are scored on a 5-pointscale (from 0 to 4) with higher numbers indicating greater symptom/problem frequency or severity. The overall score can range from a 0 to a 96.
Measured: Week 36 & Week 52
Short-Form Health Survey Emotional
The SF-12 (short form health survey) is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. For this outcome, the summed scores are from the emotional section of questionnaire. Higher scores signify lower QOL (quality of life) and the range of scores is 8-30.
Measured: Week 36 & Week 52
Short-Form Health Survey Physical
The SF-12 (short form health survey) is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. For this outcome, the summed scores are from the physical functioning section of the questionnaire. Higher scores signify lower QOL (quality of life) and the range of scores is 5-15.
Measured: Week 36 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 832 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Schnoll, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849652
- Sponsor's protocol ID
- 823871
- Other IDs
- R01CA202699
- Status last verified
- Feb 2023
- First submitted
- 14 Jul 2016
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Once the final analyses are conducted to address the specific aims of this project, study data will be made available to other qualified researchers. The investigators plan to create a mechanism to allow such researchers to apply for access to these data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing an Organizational Change Model to Address Smoking in Mental Healthcare
- ClinicalTrials.gov ID
- NCT02849652
- Acronym / sponsor ID
- 823871
- Conditions
- Nicotine Dependence
- Keywords
- Smoking cessation, Nicotine dependence, Organizational change, Mental Healthcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 832 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of California, San Diego
- Study start
- Jul 2016
- Primary completion
- Aug 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000, the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times greater than in the general population. Further, even the recent small decline in smoking rates that has been reported in the general population in the past decade has not occurred among smokers with an SMI. In fact, 44% of all the cigarettes consumed in the US are by individuals with a psychiatric disorder and the primary cause of death among Americans with an SMI is a tobacco-related disease.
This cluster randomized trial will be conducted in 14 Philadelphia community mental health clinics (CMHCs). Clinics will be randomized to either Addressing Tobacco Through Organizational Change model (ATTOC) or Usual Care (UC) treatment groups. The investigators hypothesize that 1) at the end of the intervention and at a 3-month follow-up, rates of adherence to guidelines for treating TUD will be greater among clinic personnel that receive the ATTOC intervention vs. clinic personnel in usual care; 2) at the end of the intervention and at a 3-month follow-up, rates of client smoking cessation will be significantly greater in clinics that receive the ATTOC intervention than among clients treated with usual care; and 3) using non-inferiority testing, at the end of the intervention and at a 3-month follow-up, there will be no significant degradation in mental health functioning or QOL among clients who receive care at clinics that received the ATTOC intervention than among clients treated with usual care.
Detailed description
Despite an overall reduction in US smoking rates from >50% in the 1960s to about 20% by 2000, the rate of smoking among persons with a serious mental illness (SMI) remains 2-3 times greater than in the general population. Transforming the mental healthcare system to integrate and adhere to evidence-based guidelines for the provision of tobacco use disorder (TUD) treatment is a priority of the National Institute of Mental Health and is a critical component of a national effort to meet Healthy People 2020 target goals for tobacco use (www.healthypeople.gov).
The Addressing Tobacco Through Organizational Change (ATTOC) model is a systems-level intervention to address systemic and cultural barriers that undermine assessment and treatment of TUD. In this innovative way, ATTOC assumes that effective organizational change requires more than clinic personnel training; it also requires the application of organizational theory to address attitudinal and system barriers and promote a culture in which tobacco use is not accepted or supported and that TUD treatment is integrated into standard practice. Consistent with organizational theory, ATTOC is implemented in 3 phases: preparing for, implementing, and sustaining change. By addressing cultural barriers and strengthening the care system (e.g., integrated treatment), ATTOC intends to have sustained benefits beyond the intervention.
This cluster-randomized trial will be conducted with 14 Philadelphia CMHCs, 7 randomized to ATTOC and 7 to usual care (UC). Following randomization, study staff will visit sites to recruit clinic personnel and clients over a 4 to 6 week period. Those eligible will complete informed consent and HIPAA forms and a baseline assessment to establish pre-intervention levels on all measures (baseline). After 4-6 weeks, the ATTOC intervention will be implemented over 9 months, from Week 1 to Week 36 (with UC at the control sites). Two mid-intervention assessments (Weeks 12 and 24) will allow for performance feedback and mediational analyses. Week 36 (end-of-treatment; EOT) and 52 (3-months post-EOT) assessments will allow for evaluation of changes on outcomes between groups over time. All measures will be conducted at the respective CMHC (or over the phone if necessary) and 7-day point prevalence smoking cessation will be verified using a breath carbon monoxide (CO) monitor (abstinence = < 8ppm).
This will be the first controlled, randomized trial to evaluate the effects of the ATTOC model on clinician adherence to treatment guidelines, client smoking, and client mental health and QOL. If this approach is shown to be effective and safe, it can serve as a model for the nation's community mental healthcare infrastructure, representing a powerful initiative to address tobacco use in an under-served sub-group of smokers, and support efforts to attain the Healthy People 2020 goals regarding tobacco use.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATTOC | Experimental | Behavioral: ATTOC InterventionAddressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence |
| Usual Care | Other | Behavioral: UC InterventionUsual Care is the typical guideline based smoking cessation intervention |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must be a client at a participating community mental health clinic
- Must be 18 years of age or older
- Must report daily average smoking of 5 cigarettes/day for the past 6 months
- Must have a documented Diagnostic and Statistical Manual Axis I or II disorder
- Must demonstrate the ability to communicate in English and provide written informed consent
Key exclusion criteria (2 listed)
- Exclusive use of electronic cigarettes (dual use with standard cigarettes will not be exclusionary)
- no clinical responsibilities
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 |
|---|---|---|
| ATTOC InterventionATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice. | Behavioural | ATTOC |
| UC InterventionSites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines. | Behavioural | Usual Care |
Primary outcome
Client Reported Tobacco Medications
Time frame: Week 36 & Week 52
Client-reported use of tobacco treatment for nicotine dependence measured via self-report
Rate of Medication to Treat Nicotine Dependence - EHR
Time frame: Week 36 & Week 52
Frequency of provision of medications for nicotine dependence measured via electronic health record (EHR) data for clients.
4 secondary outcomes
Smoking Cessation Rate
Time frame: Week 36 & Week 52
Mental Health Functioning
Time frame: Week 36 & Week 52
Short-Form Health Survey Emotional
Time frame: Week 36 & Week 52
Short-Form Health Survey Physical
Time frame: Week 36 and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Once the final analyses are conducted to address the specific aims of this project, study data will be made available to other qualified researchers. The investigators plan to create a mechanism to allow such researchers to apply for access to these data.
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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.
Robert Schnoll, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATTOC Intervention and UC Intervention in people with Nicotine Dependence, run by University of Pennsylvania 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 21 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Reported Tobacco Medications (time frame: Week 36 & Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2023.