Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000275460
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
1/03/2016
Date last updated
3/05/2021
Date data sharing statement initially provided
15/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial comparing the effectiveness of a more time intensive therapy with experienced alcohol and drug nurse clinicians to a Brief Information Pack for patients on a Mental health Unit with mental illness and alcohol and drug disorders in linking to the community alcohol and drug rehabilitation service of their choice.
Scientific title
A randomised single blind trial comparing more time intensive therapy with experienced alcohol and drug nurse clinicians to a Brief Information Pack and matched time with a Brief Information Pack and general conversation with student nurse on engaging patients on a Mental Health Unit with mental illness and substance use disorder in the external rehabilitation service of their choice and decreasing psychiatric symptoms and substance use.
Secondary ID [1] 288600 0
None
Universal Trial Number (UTN)
Trial acronym
SUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Disorder 297757 0
Substance Use Disorder 297793 0
Anxiety 297794 0
Psychosis 297796 0
Personality disorders 297797 0
Mood Disorder 297798 0
Condition category
Condition code
Mental Health 297938 297938 0 0
Addiction
Mental Health 297939 297939 0 0
Depression
Mental Health 297940 297940 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 3 intervention groups patients will be randomised to are: 1) Engagement Assisted Referral Therapy (EART). 2) Brief Information Pack ( BIP). 3 )BIP + Adjusted Time (AT).

EART and BIP will be delivered by experienced alcohol and drug nurse clinicians, employed by North Metropolitan Health Service - Mental Health (NMHS-MH), working at the Sir Charles Gairdner Hospital Mental Health Unit (SCGH MHU), meeting fortnightly for 1 hour of reflective practice including about adherence to the operationalised interventions. BIP is single 15 to 45 minute session. EART is single BIP session plus up to 3 X 15 to 30 minute sessions. These additional EART sessions are called modules. Each module is only administered if determined as clinically required by the treating alcohol and drug nurse clinician. Some EART group participants may only complete BIP plus module one, whereas others may complete BIP plus all modules. Patients with mood disorder, psychotic disorder and anxiety and personality disorder average 2, 3 and 4, 15 to 30 minute sessions plus an initial BIP, respectively. A session could be repeated. The frequency of sessions is variable from 1 to 5 per week. The duration of the intervention period can be for up to the length of the patient's admission. The average length of admission is 5 to 7 days but could be as short as 1 day and as long as 3 months. The clinician style is welcoming, accessible, non- judgemental, hopeful, person-centred, strengths based, recovery orientated, education focussed, goal directed, empathic and with an emphasis on personal choice.

BIP: This intervention is administered in a one-on-one, face-to-face session with an experienced alcohol and drug nurse clinician. After a welcome, explanation of the single session timeframe and the clinician’s role the patient gives their alcohol and drug use history. External treatment engagement is encouraged by identifying alcohol and drug use goals, previous treatment agencies, supports and sobriety. The pros and cons of using, cutting down and or stopping substances is explored with a motivational decisional balance activity and practicing engagement focus, evoking change talk, collaborative planning, rolling with resistance, emphasis on personal choice, regular summarizing, reviewing and checking of patient understanding.
The Brief Information Pack given to the patient includes 2 information booklets from the Government of Western Australia Drug and Alcohol Office and the Next Step Drug and Alcohol Service called the Self Help Guide and A Better Night’s Sleep, 1 Government of Western Australia Mental Health Commission pamphlet called the Alcohol and Drug Support Line.
Information Booklet and contact details for alcohol and drug community services in their area are offered dependent on patient choice.

EART: The modules selected are dependent on clinical need and administered one-on-one face-to-face with experienced alcohol and drug nurse clinicians. Modules are repeated or expanded in additional 15 - 30 minute sessions. The maximum total EART time is 2 hours and 45 minutes.

First module after BIP: A discussion about withdrawal management and coping with craving strategies could include: 1) Education about withdrawal chart, medication and tapering requirements. 2) A “Body Scan” exercise for reflection on what is happening, sleep and daily routines offering distraction. 3) The “Hungry Cat” analogy about feeding a stray cat that continues to meow louder to be fed. Unfed cravings will diminish over time. .4) The “Urge Surfing” metaphor that, like waves coming and going, mindful noticing of cravings with non-judgemental awareness and allowing, will see them pass. 5) The 6 Ds: Delay. Distract. Deep breathe. Drink water. Do something different. Decide what you want. 6) Exploration of personal strategies and distraction techniques 7) Identification of practical support options.

Alcohol and drug related discharge planning goals are set with the patient such as: 1) Giving further verbal and written information about external alcohol and drug treatment services as required to enable a choice of service.. 2) Establishing the date of discharge, chosen community alcohol and drug community rehabilitation contact details ,referral pathway and followup appointment details, the support required and 24 hour support telephone contact details .

Liaison with alcohol and drug agencies occurs, if required, to give information, with a patient's permission, to support early linkage and help with knowledge about a patient's mental health issues and followup requirements. Attendances at rehabilitation information sessions external to SCGH MHU, if available, are planned.

Liaison with the multidisciplinary SCGH MHU team occurs about expected discharge dates, suitability for a conjoint discharge planning meeting, information exchange about the progress of mental health and substance disorder treatments. .

Second module: The relapse prevention strategies of avoidance, distraction, endurance, understanding relapse triggers, the benefit of support networks and refusal strategies are discussed .

Family members, significant others, alcohol and drug services can be included in further discussions with consideration of information release, summarising and reviewing of information.

Third module: Individualised support is given for the referral to the alcohol and drug service of patient choice. Assistance is given with telephone calls, written referrals, release of information, service visits for information sessions or assessment for future residential rehabilitation admission; escorting to external appointments and taxi vouchers with or without support person or patients who are seeking the same treatment option.

Education is given that treating substance use and mental illness and stabilizing substance use problems early gives better outcomes. The impact of substance use on mental illness is explored.

BIP + (Adjusted Time) AT: The total time for this intervention equals the total time for EART, based on clinical need, taken by the previous patient randomised to EART. BIP is still provided by the SCGH MHU alcohol and drug nurse clinician. A student nurse directly follows after BIP is given, alone, one-on-one face-to- face engaging in general conversation with the patient, excluding conversation about alcohol and drug problems and treatments, for 15 – 30 minute sessions. Conversation starters act as a prompt. Student suitability is screened for by the nurse educator supervisor.

Alcohol and drug nurse clinicians record attendance in the patient's records to monitor adherence.
Intervention code [1] 294014 0
Treatment: Other
Intervention code [2] 294039 0
Behaviour
Comparator / control treatment
BIP and BIP +AT
Control group
Active

Outcomes
Primary outcome [1] 297467 0
Change in psychiatric symptom severity, as assessed by the Brief Symptom Inventory (BSI).
Timepoint [1] 297467 0
Baseline and 1, 3 and 6 months
Secondary outcome [1] 321132 0
Change in substance use will be measured by the Addiction Severity Index (ASI).
Timepoint [1] 321132 0
Baseline and 1, 3 and 6 months after discharge.
Secondary outcome [2] 321227 0
Change in harmful alcohol use will be measured by the Alcohol Use Disorder Identification Test (AUDIT).
Timepoint [2] 321227 0
Baseline and 1, 3 and 6 months after discharge
Secondary outcome [3] 321228 0
General Hospital admissions by cause will be collected from the MHIS linked with additional data sets. This data will not be collected manually by researchers from the existing systems.e ; general morbidity and mortality data; ;
Timepoint [3] 321228 0
12 months and yearly there after for up to 5 years following discharge from the mental Health Unit.
Secondary outcome [4] 321257 0
General morbidity and mortality data will be collected from the MHIS linked with additional data sets. This data will not be collected manually by researchers from the existing systems.
Timepoint [4] 321257 0
12 months and yearly there after for up to 5 years following discharge from the mental Health Unit.
Secondary outcome [5] 321258 0
Emergency Department presentations by cause will be collected from the MHIS linked with additional data sets. This data will not be collected manually by researchers from the existing systems.
Timepoint [5] 321258 0
12 months and yearly there after for up to 5 years following discharge from the mental Health Unit.
Secondary outcome [6] 321259 0
Mental health presentations by length of hospital bed will be collected from the MHIS linked with additional data sets. This data will not be collected manually by researchers from the existing systems.
Timepoint [6] 321259 0
12 months and yearly there after for up to 5 years following discharge from the mental Health Unit.

Eligibility
Key inclusion criteria
All voluntary and involuntary patients on the open Tanami ward of the SCGH MHU with both a psychiatric disorder (as defined by DSM-V) and a substance use disorder (as defined by DSM-V) that are referred to the alcohol and drug nurse clinician for interventions will be screened for eligibility for the study by the alcohol and drug nurse clinician using the key inclusion criteria are : Diagnosis of substance abuse or dependence but not a prescription medication such as opiates or benzodiazepines, defined by DSM-V; diagnosis of mental illness (defined by DSM-V); has not previously received or is currently receiving EART or BIP; resident of SCGH Mental Health Unit; plans to reside in Australia for the duration of follow-ups; available for follow-up for at least 6 months; able to comply with requirements of the protocol; able and willing to understand and provide written informed consent; between 18 and 65 years of age.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The Exclusion Criteria are: woman during the lactation period or pregnant; patient is highly dependent on medical care; patient has a significant communication barrier. Patients who want No Intervention are screened out earlier by not wanting a referral to the alcohol and drug nurse clinician when asked by their multidisciplinary team on or after arrival at the SCGH MHU. If there are too many referrals to the alcohol and drug nurse clinician to handle (estimated as greater than 4) then a random selection will be made.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
31/05/2016
Actual
10/01/2017
Date of last participant enrolment
Anticipated
8/05/2020
Actual
17/08/2019
Date of last data collection
Anticipated
20/11/2020
Actual
15/02/2020
Sample size
Target
47
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292962 0
Government body
Name [1] 292962 0
North Metropolitan Health - Mental Health
Country [1] 292962 0
Australia
Funding source category [2] 292963 0
University
Name [2] 292963 0
University of Western Austrslia
Country [2] 292963 0
Australia
Primary sponsor type
Individual
Name
Dr Ann Solar
Address
Sir Charles Gairdner Hospital Mental Health Unit
Verdun Street
Nedlands
Western Australia
6009
Country
Australia
Secondary sponsor category [1] 291763 0
None
Name [1] 291763 0
None
Address [1] 291763 0
None
Country [1] 291763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294464 0
North Metropolitan Health Service - Mental Health Human Research Ethics Committee
Ethics committee address [1] 294464 0
Ethics committee country [1] 294464 0
Australia
Date submitted for ethics approval [1] 294464 0
Approval date [1] 294464 0
12/02/2016
Ethics approval number [1] 294464 0
Ethics committee name [2] 294465 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 294465 0
Ethics committee country [2] 294465 0
Australia
Date submitted for ethics approval [2] 294465 0
23/03/2016
Approval date [2] 294465 0
Ethics approval number [2] 294465 0
Ethics committee name [3] 294466 0
Department of Health Human Research Ethics Committee
Ethics committee address [3] 294466 0
Ethics committee country [3] 294466 0
Australia
Date submitted for ethics approval [3] 294466 0
20/04/2016
Approval date [3] 294466 0
Ethics approval number [3] 294466 0

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

Contacts
Principal investigator
Name 63770 0
Dr Ann Solar
Address 63770 0
Sir Charles Gairdner Mental Health Unit
Verdun Street
Nedlands
Western Australia
6009
Country 63770 0
Australia
Phone 63770 0
+61 8 63831000
Fax 63770 0
Email 63770 0
[email protected]
Contact person for public queries
Name 63771 0
Jane Chambers
Address 63771 0
Sir Charles Gairdner Mental Health Unit
Verdun Street
Nedlands
Western Australia
6009
Country 63771 0
Australia
Phone 63771 0
+61 8 63831000
Fax 63771 0
Email 63771 0
[email protected]
Contact person for scientific queries
Name 63772 0
Ann Solar
Address 63772 0
Sir Charles Gairdner Mental Health Unit
Verdun Street
Nedlands
Western Australia
6009
Country 63772 0
Australia
Phone 63772 0
+61 8 63831000
Fax 63772 0
Email 63772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have approval from Ethics committee. All data is locked in principle researcher's office space and computer data is password protected.


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.