Testing an Organizational Change Model to Address Smoking in Mental Healthcare
2 other identifiers
interventional
832
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 14, 2016
CompletedFirst Posted
Study publicly available on registry
July 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedResults Posted
Study results publicly available
February 21, 2023
CompletedFebruary 21, 2023
February 1, 2023
6.1 years
July 14, 2016
December 13, 2022
February 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Client Reported Tobacco Medications
Client-reported use of tobacco treatment for nicotine dependence measured via self-report
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.
Week 36 & Week 52
Secondary Outcomes (4)
Smoking Cessation Rate
Week 36 & Week 52
Mental Health Functioning
Week 36 & Week 52
Short-Form Health Survey Emotional
Week 36 & Week 52
Short-Form Health Survey Physical
Week 36 and Week 52
Other Outcomes (5)
S-KAP: Staff-Reported Tobacco Treatment Treatment
Week 36 and Week 52
S-KAP: Staff-Reported Barriers to Treat Tobacco
Week 36 and Week 52
S-KAS: Client Reported Tobacco Treatment Treatment From Staff
Week 36 and Week 52
- +2 more other outcomes
Study Arms (2)
ATTOC
EXPERIMENTALAddressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
Usual Care
OTHERUsual Care is the typical guideline based smoking cessation intervention
Interventions
ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- no clinical responsibilities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- National Cancer Institute (NCI)collaborator
- University of California, San Diegocollaborator
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Robert Schnoll
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Schnoll, PhD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2016
First Posted
July 29, 2016
Study Start
July 1, 2016
Primary Completion
August 1, 2022
Study Completion
December 1, 2022
Last Updated
February 21, 2023
Results First Posted
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Final analyses will be conducted after all participant activities have been completed, approximately 9/2021. Once the final analyses are conducted to address the specific aims of this project, study data will be made available.
- Access Criteria
- 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.
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.