ANZCTR - Registration

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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

mental health

drug interactions

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

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]

Other interventions

Intervention code [2]

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]

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]

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]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/01/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Way

Address [1]

Third Floor, 46 Parliament Place
West Perth
Western Australia 6005

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Hospital (HREC)

Ethics committee address [1]

Hospital Avenue, Nedlands, Western Australia 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/12/2008

Approval date [1]

12/03/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Gary Hulse

Address

School of Psychiatry & Clinical Neurosciences
University of Western Australia (MPC 521)
QEII Medical Centre, Nedlands WA 6907

Country

Australia

Phone

+61 8 93462280

Fax

gary.hulse@uwa.edu.au

Contact person for scientific queries

Name

Professor Gary Hulse

Address

School of Psychiatry & Clinical Neurosciences
University of Western Australia (MPC 521)
QEII Medical Centre, Nedlands WA 6907

Country

Australia

Phone

+61 8 9346 2280

Fax

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.

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