Testing an Organizational Change Model to Address Smoking in Mental Healthcare

NCT ID: NCT02849652

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 832 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2022-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

ATTOC

Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence

Group Type: EXPERIMENTAL

ATTOC Intervention

Intervention Type: BEHAVIORAL

ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.

Usual Care

Usual Care is the typical guideline based smoking cessation intervention

Group Type: OTHER

UC Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Exclusive use of electronic cigarettes (dual use with standard cigarettes will not be exclusionary)

• no clinical responsibilities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Schnoll, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01CA202699

Identifier Type: NIH

Identifier Source: secondary_id

View Link

823871

Identifier Type: -

Identifier Source: org_study_id