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Testing an Organizational Change Model to Address Smoking in Mental Healthcare

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ClinicalTrials.gov Identifier: NCT02849652
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : December 6, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, San Diego
Information provided by (Responsible Party):
University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: ATTOC Intervention Behavioral: UC Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Testing an Organizational Change Model to Address Smoking in Mental Healthcare
Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: ATTOC
Addressing Tobacco Through Organizational Change is a multi-phase organizational intervention to promote the treatment of tobacco dependence
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.

Usual Care
Usual Care is the typical guideline based smoking cessation intervention
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.




Primary Outcome Measures :
  1. Rate of treatment of nicotine dependence - Self-report [ Time Frame: Change from baseline to Week 36 & Week 52 ]
    Frequency of provision of treatment for nicotine dependence measured via self-report

  2. Rate of treatment of nicotine dependence - EHR [ Time Frame: Change from baseline to Week 36 & Week 52 ]
    Frequency of provision of treatment for nicotine dependence measured via electronic health record (EHR) data


Secondary Outcome Measures :
  1. Smoking cessation rate [ Time Frame: Change in smoking from baseline to Week 12, Week 24, Week 36, & Week 52 ]
    Change in proportion of smoking from baseline to follow-up time-points

  2. Mental health functioning [ Time Frame: Change from baseline to Week 12, Week 24, Week 36, & Week 52 ]
    Participants will complete 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.

  3. Client hospitalization assessment [ Time Frame: Change from baseline to Week 36 & Week 52 ]
    The frequency and duration of any illness-related client hospitalization. This self-report measure will be confirmed via EHR review at each assessment time point.

  4. Short-Form Health Survey [ Time Frame: Change from baseline to Week 12, Week 24, Week 36, & Week 52 ]
    This survey will assess physical and mental QOL of client participants.

  5. Treatment and Client Costs [ Time Frame: Change from baseline to Week 36 & Week 52 ]
    These costs will be estimated by multiplying the counts of resources used by the unit costs of those resources (the resource costing method), which summarizes the health care services used from the perspective of society (e.g., TUD treatment delivery time), not only protocol costs. ATTOC direct costs will be considered as will non-study medical services costs, recorded on a validated scale.


Other Outcome Measures:
  1. Smoking Knowledge, Attitudes, and Practices (S-KAP) [ Time Frame: Change from baseline to Week 12, Week 24, Week 36, & Week 52 ]
    This survey is composed of 5 scales that assess system and cultural barriers to providing treatment for smoking (from the healthcare provider perspective).

  2. Smoking Knowledge, Attitudes, and Services (S-KAS) [ Time Frame: Change from baseline to Week 12, Week 24, Week 36, & Week 52 ]
    This survey assesses barriers to treating nicotine dependence from the client's perspective.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849652


Contacts
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Contact: Alex Flitter 215-898-9934 aflitter@mail.med.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alex Flitter    215-898-9934    aflitter@mail.med.upenn.edu   
Principal Investigator: Robert Schnoll, PhD         
Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
University of California, San Diego
Investigators
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Principal Investigator: Robert Schnoll, PhD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02849652     History of Changes
Other Study ID Numbers: 823871
R01CA202699 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (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.
Keywords provided by University of Pennsylvania:
Smoking cessation
Nicotine dependence
Organizational change
Mental Healthcare
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders