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Trial registered on ANZCTR


Registration number
ACTRN12609000627257
Ethics application status
Approved
Date submitted
20/07/2009
Date registered
28/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Admissions to a "Smokefree" hospital to promote cessation of smoking in mental health inpatients versus a representation of the general population.
Scientific title
The effect of a quit smoking program on the intention of mental health inpatients versus orthopaedic, plastic surgery and neurosurgery inpatients (as representative of the general population) to adopt smoking cessation strategies.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nicotine dependence 237300 0
mental health 237354 0
drug interactions 237355 0
Condition category
Condition code
Public Health 239623 239623 0 0
Health promotion/education
Mental Health 239676 239676 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Quit Smoking Resources:
Information brochure and booklets from Dept of Health
Advice sheets from Quit Coach

Nicotine Replacement Therapy(NRT):
Patients are offered - patches, inhaler, gum, microtabs and lozenges. Patients are instructed to use the NRT as directed on the packet guidelines upon discharge.

Online Quit Coach Registration:
Patient is given opportunity to register with Quit Coach, answers questions and gets tailored advice sheet. They also get email notifications from the application. After the initial registration patients are advised to use Quit Coach online at there own discretion.

SMS Messages:
Patients receive encouragement, advice and relapse prevention messages from a desktop messaging service. Patients will receive SMS Messages (once a week until 14 day post discharge, once a fortnight until 3 months post discharge and once a month until 6 months post discharge)

Telephone Counselling:
Patient receives telephone counseling administered by a Motivational Interviewer trained in stop smoking techniques (once a week)
Intervention code [1] 236976 0
Other interventions
Intervention code [2] 236977 0
Behaviour
Comparator / control treatment
Orthopedic, Plastic Surgery and Neurosurgery patients used as control group, wards G51 and G53.

This group receives Baseline Survey, NRT whilst in hospital and follow up at 14 day and 6 months only.
Control group
Active

Outcomes
Primary outcome [1] 238408 0
To identify the intention of mental health inpatients versus orthopaedic, plastic surgery and neurosurgery inpatients (ie: wards G51 & G53) to adopt smoking cessation strategies:

Patient contacted on admission to hospital - then every 3 days til discharge.
Patient follow up phone interviews at 4,14 days, 3,6 months (questionnaires)
Focus group at 6 months to identify outcome obstacles and other tools to aid intervention.
Saliva test on specific patients to determine levels on nicotine in system at 6 months
Timepoint [1] 238408 0
Patient follow up phone interviews at 4,14 days, 3,6 months post discharge by questionnaires.
Focus group at 6 months to identify outcome obstacles and other tools to aid intervention.
Saliva test on specific patients to determine levels on nicotine in system at 6 months
Secondary outcome [1] 244884 0
To determine the 'stage of change' for quitting smoking in both groups and compare
i. during hospital stay (where cessation is enforced) - questionnaires (face to face)
ii. predischarge - questionnaires (phone)
iii. postdischarge - questionnaires (phone)

Focus groups at 6 months post discharge
Timepoint [1] 244884 0
Patient follow up phone interviews at 4,14 days, 3,6 months post discharge by questionnaires.
Focus group at 6 months to identify outcome obstacles and other tools to aid intervention.
Saliva test on specific patients to determine levels on nicotine in system at 6 months

Eligibility
Key inclusion criteria
All English speaking smokers on the respective wards 1) deemed able to give informed consent by hospital staff and sufficiently well to be interviewed, 2) willing to provide individual written consent and 3) able to provide an address with telephone number post-discharge.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to give informed consent. 2. non English speaking persons. 3. Unable to provide an address with telephone number post discharge

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As per study number Human Research Ethics Committee (HREC), Sir Charles Gairdner Hospital (SCGH) reference no: 2008-162.

"Allocation is not concealed"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will be randomising 200 subjects into 2 groups 'control' and 'intervention'. Numbers were generated in Excel Spreadsheet.

Control Group: Randomized mixture of Ortho, Plastic, Nuero and Mental Health Patients

Intervention Group: Randomised Mental Health Patient only.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237361 0
Government body
Name [1] 237361 0
Health Way
Address [1] 237361 0
Third Floor, 46 Parliament Place
West Perth
Western Australia 6005
Country [1] 237361 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Psychiatry & Clinical Neurosciences
University of Western Australia (MPC 521)
QEII Medical Centre, Nedlands WA 6907
Country
Australia
Secondary sponsor category [1] 236856 0
None
Name [1] 236856 0
Address [1] 236856 0
Country [1] 236856 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239489 0
Sir Charles Gairdner Hospital (HREC)
Ethics committee address [1] 239489 0
Hospital Avenue, Nedlands, Western Australia 6009
Ethics committee country [1] 239489 0
Australia
Date submitted for ethics approval [1] 239489 0
10/12/2008
Approval date [1] 239489 0
12/03/2009
Ethics approval number [1] 239489 0
Reference Number: SCGH HREC: 2008-162

Summary
Brief summary
To investigate the interest of persons in attempting to quit cigarette smoking while hospital inpatients and to identify activities to assist them to do this.

The study uses a longitudinal prospective design to collect survey data from two cohorts of hospital inpatients: those recruited from a mental health ward and those from orthopaedic, plastic surgery & neurosurgery wards (The orthopaedic, plastic and neurosurgery patients are collected from the orthopaedics wards G51 & G53 at Sir Charlie Gairdner Hospital only). In addition, two sub-sets of participants (those who are not interested in quitting smoking and those that want to quit) from the mental health cohort will be allocated (randomised) to a “normal contact” or “intervention” group with 100 people per group.

As part of hospital management, all patients who are smokers and are admitted as inpatients will, at the time of admission, be informed of a strict smoking ban within the hospital and its grounds and be offered nicotine replacement.

All participants complete a consent form and receive the patient information sheet; they then complete the baseline questionnaire. Those that are allocated to the ‘normal group’ are then interviewed 4 days and 6 months post discharge from the hospital.

Those allocated to the ‘intervention group’ are followed up every 3 days whilst in hospital, offered additional ‘Quit Smoking’ resources and access to an online an ‘Quit’ program. On discharge they are given ‘one months’ supply of nicotine replacement therapy (see patient information sheet for NRT offered) and also followed up at 4, 14 days and 3, 6 months post discharge. Furthermore the ‘intervention group’ receive a series of encouragement, relapse prevention and handy tips via SMS messages up until 6 months post discharge plus additional counseling and aid via telephone.

At 6 months a subset of participants will be invited to take part in focus groups to provide a detailed investigation of the needs of patients to aid cessation both pre and post-discharge.

This study will look a few hypotheses:

? Patients will find it easier to reduce tobacco intake in a ‘Non Smoking’ Hospital environment with the aid of longer term health promotion intervention?

? Mental Health Patients will find reducing smoking patterns more difficult compared to ‘normal’ group
o Due to the environment ie: high level of smokers will increase uptake of smoking whilst in ‘adult mental health units’
o Patients are dealing with a number of ‘mental health’ issues, therefore increased stress levels may increase tobacco intake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29930 0
Address 29930 0
Country 29930 0
Phone 29930 0
Fax 29930 0
Email 29930 0
Contact person for public queries
Name 13177 0
Professor Gary Hulse
Address 13177 0
School of Psychiatry & Clinical Neurosciences
University of Western Australia (MPC 521)
QEII Medical Centre, Nedlands WA 6907
Country 13177 0
Australia
Phone 13177 0
+61 8 93462280
Fax 13177 0
Email 13177 0
gary.hulse@uwa.edu.au
Contact person for scientific queries
Name 4105 0
Professor Gary Hulse
Address 4105 0
School of Psychiatry & Clinical Neurosciences
University of Western Australia (MPC 521)
QEII Medical Centre, Nedlands WA 6907
Country 4105 0
Australia
Phone 4105 0
+61 8 9346 2280
Fax 4105 0
Email 4105 0
gary.hulse@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
No Results