CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 832 enrolled
Drug / intervention
ATTOC Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02849652
NCT02849652N/ACompleted

Testing an Organizational Change Model to Address Smoking in Mental Healthcare

University of Pennsylvania·interventional·Posted Jul 29, 2016·Updated Feb 21, 2023

In Brief

A clinical study evaluating ATTOC Intervention and UC Intervention for Nicotine Dependence. Completed, enrolled 832 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 29, 2016
Enrollment StartJul 1, 2016
Primary CompletionAug 1, 2022
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 9.9 years ago

Interventions

ATTOC Interventionbehavioral

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 Interventionbehavioral

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.