Testing an Organizational Change Model to Address Smoking in Mental Healthcare

Nicotine Dependence Clinical Trial

Official title:

Testing an Organizational Change Model to Address Smoking in Mental Healthcare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849652
• Other study ID #: 823871
• Secondary ID: R01CA202699
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2022

Study information

• Verified date: February 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 832
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• ATTOC Intervention
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 Intervention
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI), University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	S-KAP: Staff-Reported Tobacco Treatment Treatment	The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective). The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26.	Week 36 and Week 52
Other	S-KAP: Staff-Reported Barriers to Treat Tobacco	The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective). The scores are from the summed items. Higher scores equal more barriers to tobacco treatment with the range of scores being 0-13.	Week 36 and Week 52
Other	S-KAS: Client Reported Tobacco Treatment Treatment From Staff	The Smoking Knowledge, Attitudes, and Services (S-KAS) survey assesses barriers to treating nicotine dependence from the client's perspective. The scores are from the summed items. Higher scores mean more tobacco treatment and the range of scores is 7-35.	Week 36 and Week 52
Other	S-KAP: Staff-Reported Skills to Treat Tobacco Treat Tobacco	The Smoking Knowledge, Attitudes, and Practices instrument is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective).The scores are from the summed items. Higher scores equal more skills and the range of scores is: 0-26.	Week 36 and Week 52
Other	S-KAS: Client Reported Tobacco Services and Policies Services and Policies	The Smoking Knowledge, Attitudes, and Services (S-KAS) survey assesses barriers to treating nicotine dependence from the client's perspective. The scores are from the summed items Higher scores equal more tobacco services. The range of scores is: 1-14.	Week 36 and Week 52
Primary	Client Reported Tobacco Medications	Client-reported use of tobacco treatment for nicotine dependence measured via self-report	Week 36 & Week 52
Primary	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	Smoking Cessation Rate	Change in proportion of smoking from baseline to follow-up time-points for clients	Week 36 & Week 52
Secondary	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.	Week 36 & Week 52
Secondary	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.	Week 36 & Week 52
Secondary	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.	Week 36 and Week 52