Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001137684
Ethics application status
Approved
Date submitted
8/10/2014
Date registered
27/10/2014
Date last updated
30/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Emergency Department Screening and Brief Interventions for Heavy and Hazardous use of substances: A feasibility study.
Scientific title
A feasibility study of Emergency Department patient screening and brief intervention for heavy and hazardous use of substances (alcohol and other drugs)
Secondary ID [1] 285458 0
Nil
Universal Trial Number (UTN)
U1111-1162-6993
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heavy and hazardous use of alcohol and or other drugs 293232 0
Condition category
Condition code
Mental Health 293501 293501 0 0
Other mental health disorders
Public Health 293578 293578 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administering a screening for substance use and if patient screens at high risk of substance use disorder a nurse administers a 3-10 minute counselling session.
The questionnaire is an independently validated existing tool called Alcohol Smoking and Substance Involvement Screening Test (ASSIST) in a shortened version most appropriate for the busy Emergency Department (ED) setting, called ASSIST-Lite. Questions are about use of selected substances within the past 3 months. ASSIST-Lite is a one page written questionnaire that the patient can fill out themselves. It will be handed out and collected by a Registered Nurse (RN). The counselling is motivational interviewing aimed at reducing use, it is a single stand alone session requiring no follow up for the patient.
Intervention code [1] 290391 0
Early detection / Screening
Intervention code [2] 290392 0
Lifestyle
Intervention code [3] 290448 0
Behaviour
Comparator / control treatment
Nil, feasibility study not effectiveness study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293322 0
Number of eligible patients who complete ASSIST-Lite screening. To be assessed through an audit of the patients charts.
Timepoint [1] 293322 0
one month after the start of the study
Primary outcome [2] 293390 0
Number of patients who screen at risk of harmful substance use who receive an intervention. Risk score is different for different substances and is a score of either 2 or 3 depending on substance, the intervention is provided for the persons highest scoring substance if any score above 2 or 3. The intervention is a 3-15 minute motivational interviewing session aimed at reducing substance use. Outcome will be assessed by an audit of the patient charts for qualitative data (how often is the screening and intervention happening).
Timepoint [2] 293390 0
one month after the start of the study
Secondary outcome [1] 310795 0
Nurses feeling that Screening and Brief Intervention can be provided in the future.
Participating nurses will be interviewed in a face to face structured individual interviews conducted by the primary investigator, that will be transcribed and analysed thematically.
Timepoint [1] 310795 0
6 months after the completion of the trial period

Eligibility
Key inclusion criteria
Patients at Waitakere hospital Emergency Dept in Waiting, Consults, Acutes and Monitored areas who are medically fit in the professional opinion of RN, Doctor or Mental Health Nurse as appropriate. Ages 18-80.
There are 2 participant groups: nurses and patients. Nurses are volunteers, selected to give a cross section of ED staff but must have at least 1 yr ED experience. Patients are a convenience sample of eligible patients who present and are cared for by a participating nurse and who agree to participate.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emotional distress, Mentally unwell (unless MH nurse/doctor thinks it is in the best interest of the patient), chest pain, shortness of breath, life threatening condition, severe or moderate pain, cognitive impairment, any condition that makes patient unable to give informed consent. Language barrier.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
non randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Qualitative study design
Phase
Type of endpoint/s
Statistical methods / analysis
Descriptive stats for numerical data (how often screening/intervention is done), and thematic analysis for interviews of nurses post trial month about their experiences.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2015
Actual
1/01/2015
Date of last participant enrolment
Anticipated
18/03/2015
Actual
18/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
500
Recruitment outside Australia
Country [1] 6398 0
New Zealand
State/province [1] 6398 0
Auckland

Funding & Sponsors
Funding source category [1] 290066 0
Self funded/Unfunded
Name [1] 290066 0
Country [1] 290066 0
Primary sponsor type
Individual
Name
Kylie Travers
Address
Waitakere Hospital, Lincoln Road, Henderson, Auckland 0610.
Country
New Zealand
Secondary sponsor category [1] 288755 0
None
Name [1] 288755 0
Address [1] 288755 0
Country [1] 288755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291770 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 291770 0
Ethics committee country [1] 291770 0
New Zealand
Date submitted for ethics approval [1] 291770 0
11/11/2014
Approval date [1] 291770 0
20/11/2014
Ethics approval number [1] 291770 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51954 0
Miss kylie Travers
Address 51954 0
Waitakere Hospital, Lincoln Rd, Henderson 0610.
Country 51954 0
New Zealand
Phone 51954 0
+6499713881
Fax 51954 0
Email 51954 0
zaksminion@gmail.com
Contact person for public queries
Name 51955 0
Kylie Travers
Address 51955 0
Waitakere Hospital, Lincoln Rd, Henderson 0610.
Country 51955 0
New Zealand
Phone 51955 0
+6499713881
Fax 51955 0
Email 51955 0
zaksminion@gmail.com
Contact person for scientific queries
Name 51956 0
Kylie Travers
Address 51956 0
Waitakere Hospital, Lincoln Rd, Henderson 0610.
Country 51956 0
New Zealand
Phone 51956 0
+6499713881
Fax 51956 0
Email 51956 0
zaksminion@gmail.com

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.