Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000277448
Ethics application status
Approved
Date submitted
15/05/2007
Date registered
22/05/2007
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the impact of the smoking cessation policy on the wellbeing of mental health in-patients and the implications for hospital staff
Scientific title
Assessment of the impact of the smoking cessation policy on the wellbeing of mental health in-patients and the implications for hospital staff
Universal Trial Number (UTN)
Trial acronym
SCiMHS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation (tobacco) among mental health in-patients 1817 0
Condition category
Condition code
Mental Health 1907 1907 0 0
Addiction
Mental Health 1908 1908 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study pre-introduction of a non-smoking policy in public hospitals in Western Australia. The initial phase is collecting data from inpatients on mental health wards on history of smoking, attitude to the proposed smoking ban and anticipated consequences of the introduction of the ban. Data collection: 3-4 weeks May-June 2007. (Further data collection is dependent of further funding.)
Intervention code [1] 1758 0
None
Comparator / control treatment
This is an observational study there is no comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2714 0
Attitudes of mental health in-patients to the policy: Data collection via an interviewer administered questionnaire.
Timepoint [1] 2714 0
Data collection May - June 2007
Secondary outcome [1] 4582 0
Staff and patient focus groups: June 2007. These groups will be used to identify concerns and issues for staff and patients and will be used in designing a future intervention and advising on managing the transition to a smoke free environment.
Timepoint [1] 4582 0
Data collection May-June 2007

Eligibility
Key inclusion criteria
Mental health inpatients at 3 Western Australia hospitals (Bentley, Fremantle and Sir Charles Gairdner Hospitals). Consent by medical staff, English speaking, patient consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not matching inclusion criteria.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2053 0
Government body
Name [1] 2053 0
Office of Mental Health, Department of Health, Western Australia
Country [1] 2053 0
Australia
Primary sponsor type
University
Name
University of Western Australia, School of Psychiatry & Clinical Neurosciences
Address
35 Stirling Highway, Crawley
Country
Australia
Secondary sponsor category [1] 1861 0
None
Name [1] 1861 0
not applicable
Address [1] 1861 0
Country [1] 1861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3816 0
University of Western Australia- Sir Charles Gairdner Hospial
Ethics committee address [1] 3816 0
Ethics committee country [1] 3816 0
Australia
Date submitted for ethics approval [1] 3816 0
Approval date [1] 3816 0
09/05/2007
Ethics approval number [1] 3816 0
RA/4/1/1764
Ethics committee name [2] 3817 0
University of Western Australia-Bentley Health Service and Fremantle Hospital
Ethics committee address [2] 3817 0
Ethics committee country [2] 3817 0
Australia
Date submitted for ethics approval [2] 3817 0
Approval date [2] 3817 0
09/05/2007
Ethics approval number [2] 3817 0
RA/4/1/1764

Summary
Brief summary
1. To identify the prevalence of smoking and the potential impact upon patients entering into a non-smoking mental health environment.
2. To identify possible changes in patient refusal for admission / discharge due to smoking restrictions, and on the potential for a change in the ratio of voluntary / involuntary admissions.
3. To identify the relationship between the impact of staff implementing the smoking cessation policy and possible violence against staff & behavioural patient management
4. Establish baseline status of prescribed medications whose actions are known to be modified by smoking
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27861 0
Address 27861 0
Country 27861 0
Phone 27861 0
Fax 27861 0
Email 27861 0
Contact person for public queries
Name 10947 0
Dr Robert Tait
Address 10947 0
School of Psychiatry & Clinical Neurosciences
University of Western Australia
D Block
QE II Medical Centre
Gairdner Drive
Nedlands WA 6009
Country 10947 0
Australia
Phone 10947 0
+61 8 93462281
Fax 10947 0
Email 10947 0
robert.tait@uwa.edu.au
Contact person for scientific queries
Name 1875 0
Professor Gary Hulse
Address 1875 0
School of psychiatry & Clinical Neurosciences
University of Western Australia
D Block
QE II Medical Centre
Gairdner Drive
Nedlands WA 6009
Country 1875 0
Australia
Phone 1875 0
+61 8 93462280
Fax 1875 0
Email 1875 0
gary.hulse@uwa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.