N/A
N=832
Testing an Organizational Change Model to Address Smoking in Mental Healthcare
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02849652 ↗Enrolled (actual)
832
Serious AEs
5.9%
Results posted
Feb 2023
Primary outcome: Primary: Client Reported Tobacco Medications — 48; 28; 62; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ATTOC Intervention (Behavioral); UC Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Client Reported Tobacco Medications |
48; 28; 62; 24 | — |
| PRIMARY Rate of Medication to Treat Nicotine Dependence - EHR |
20; 33; 20; 21 | — |
| SECONDARY Smoking Cessation Rate |
11; 4; 17; 9 | — |
| SECONDARY Mental Health Functioning |
27.3; 31.8; 28.7; 30.9 | — |
| SECONDARY Short-Form Health Survey Emotional |
18.6; 18.5; 17.9; 18.8 | — |
| SECONDARY Short-Form Health Survey Physical |
9.5; 9.8; 9.6; 10.1 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria (clinic client participants):
- 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
Exclusion Criteria (clinic client participants):
- Exclusive use of electronic cigarettes (dual use with standard cigarettes will not be exclusionary)
Inclusion Criteria (Clinic personnel participants):
- 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
Exclusion Criteria
- no clinical responsibilities
Data sourced from ClinicalTrials.gov (NCT02849652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.