Testing an Organizational Change Model to Address Smoking in Mental Healthcare



Status:Recruiting
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 99
Updated:2/23/2019
Start Date:July 2016
End Date:April 2021
Contact:Alex Flitter
Email:aflitter@mail.med.upenn.edu
Phone:215-898-9934

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Robert Schnoll, PhD
Phone: 215-898-9934
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials