Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000254695
Ethics application status
Approved
Date submitted
31/01/2023
Date registered
9/03/2023
Date last updated
9/03/2023
Date data sharing statement initially provided
9/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of 'First step' into Alcohol and Drug Services – A stepped-wedge cluster randomised trial
Scientific title
Effect of the implementation of 'First step' into Alcohol and Drug Services on service delivery – A stepped-wedge cluster randomised trial
Secondary ID [1] 308831 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a second phase-study linked to ACTRN12621000467831

Health condition
Health condition(s) or problem(s) studied:
Substance use 328788 0
Mental Health 328789 0
Condition category
Condition code
Mental Health 325798 325798 0 0
Addiction
Mental Health 325799 325799 0 0
Depression
Mental Health 325800 325800 0 0
Anxiety
Mental Health 325801 325801 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective stepped wedge cluster randomised trial will be conducted. The design involves random and sequential crossover of clusters from standard treatment to First Step until all clusters have implemented First Step.

First Step is a manualised brief intervention for substance use that consists of three modules delivered over two treatment sessions. It is delivered to clients as the first step of treatment prior to commencing standard treatment in outpatient, residential, day programs or withdrawal AOD treatment services. The delivery of brief interventions are currently not standard practice at service entry.

Module 1 and 2 are usually delivered in the first session (30-60 minutes). Module 3 is typically delivered in one 30-45 minute session, 1-2 weeks after Module 1 and 2.

Module 1 - Assessment/Feedback/Information: All clients entering the cluster will be asked to complete a pre-intervention online assessment of their substance use, mental and physical health, quality of life and functioning (outcome measures) before enrolment into the service. They are then asked to repeat this survey at 1 and 3 months follow up, regardless of whether they are still enrolled in treatment. The survey is automatically scored by a website, which also provides immediate feedback to clients and staff via email and SMS. The feedback incorporates figures, normative data, and hyperlinks to substance-related fact sheets and information sheets on common comorbid presentations. In Module 1, staff are trained to provide feedback to the clients using the feedback sheets to increase the client’s awareness of the extent and impact of their substance use. Psychoeducation is also offered to the client using relevant substance-related fact sheets and information sheets on common comorbid conditions. They also introduce and demonstrate the use of progress charts which the client receives when they complete outcome measures at one and three-months follow up.

Module 2 - Motivational Interviewing: focuses on motivational enhancement and goal setting. Motivational interviewing techniques are used to build motivation and commitment to change. The client’s patterns of substance use are first explored, and the pros and cons of making a change/not making a change in their substance use are discussed. Options for change (reduce substance use or the potential harm associated with use) are then explored. The module ends with the client setting a substance-related goal using an implementation intention framework. These are supported by worksheets and information sheets.

Module 3 - Targeted Coping Skills Training: explores risk profiles that may underlie the client’s substance use behaviours and provides training in 2-3 coping strategies to target them. It ends with the client setting a second substance use goal which incorporates coping, using an implementation intention framework. There are accompanying worksheets to assist clients to complete and practice their relevant coping strategies.

Clients who complete First Step and request or require further treatment (based on the clinician's judgement) will continue counselling (see standard AOD care below) or be referred to more intensive treatment (e.g. residential) at the participating service or elsewhere

All of the feedback/information/harm minimisation sheets/worksheets/resources provided as part of the intervention to both clients and counsellors were designed specifically for this study.

First step will be delivered by AOD counsellors in each treatment site. They will be provided with a 2-day workshop on the First Step program one month before the intervention is due to commence at the site. Staff receive resources and weekly clinical supervision and support for 4 weeks post training.
Intervention code [1] 325277 0
Treatment: Other
Comparator / control treatment
Standard AOD care
The control group receives AOD care in accordance with standard practice at the participating site. People who contact the service are referred to community (outpatient), residential (inpatient), day program (outpatient) or withdrawal (inpatient and outpatient) treatment, according to their preference and an initial assessment of their treatment needs.

All clients entering treatment are asked to complete an online self-report assessment of their substance use, mental and physical health, quality of life and functioning (outcome measures) either face-to-face or via email. They are then asked via email to repeat this survey at 1 and 3 months follow up, regardless of whether they are still enrolled in treatment. The clinician receives summary data on the client’s outcome measures via Qualtrics in text format, without any figures, normative data, fact sheets or harm minimisation resources. The clinician is expected to provide the client with a basic verbal summary of their results. The client does not receive a copy of the feedback. Unlike First Step, clients are not required to complete the baseline outcome measure survey before they enter standard treatment. The delivery of brief interventions are currently not standard practice at service entry.

The different types of standard AOD care are described below:

Community standard outpatient AOD care: Typically consists of case management and AOD counselling, delivered via phone or face to face by a clinician. A typical episode of care consists of 2–10 sessions. Standard care is not based on specific guidelines, nor does it have
a prescribed number of sessions, frequency or duration of sessions; as this is determined on a case by case basis by the AOD worker. Typical treatment approaches used include cognitive behaviour therapy (CBT) for substance use, motivational interviewing, psychoeducation and
counselling.

Residential Rehabilitation: Typically consists of a 6-week inpatient treatment program, with a maximum length of stay of 12 weeks, and telephone support by pretreatment/post-treatment AOD workers to assist with admission into the residential facility and the transition back to the community. The program includes regular group sessions covering substance use (eg, triggers, cravings, building motivation to change, drug refusal skills), emotion regulation and management, social skills, developing a relapse prevention plan; one on one counselling/case management; as well as creativity, exercise, nutrition and relaxation activities.

Day program: These 3 to 6-week programs are delivered on an outpatient basis. They provide
case management, AOD counselling and support, and group programs similar to those of delivered in the residential rehabilitation services.

Withdrawal programs: These programs integrate withdrawal support/detox with medical support, case management, AOD counselling and group programs. They length of these programs typically vary from 5 to 14 days and they are delivered on both an inpatient and outpatient (mobile and day programs) basis.

All outpatient and day programs are free. Clients of inpatient programs are required to pay some money towards their stay, usually a portion of their government benefits.
Control group
Active

Outcomes
Primary outcome [1] 333643 0
Number of client outcome measure surveys completed that were sent at each survey point (baseline, one- and three-months follow up) in the standard care versus First Step clusters

Outcome measure completion is defined as completion of all of the measures (yes/no) within a single online survey at each of the following time-points

Baseline
1. Alcohol, Smoking, Substance Involvement Screening Test (ASSIST)
2. Australian Treatment Outcome Profile (ATOP)
3. Patient Health Questionnaire – 9 (PHQ-9)
4. Generalized Anxiety Disorders – 7 (GAD-7)
5. Primary care PTSD screen (PC-PTSD)
6. Psychosis question

One-month follow up
1. Australian Treatment Outcome Profile (ATOP)
2. Patient Health Questionnaire – 9 (PHQ-9)
3. Generalized Anxiety Disorders – 7 (GAD-7)

Three-month follow up
1. Alcohol, Smoking, Substance Involvement Screening Test (ASSIST)
2. Australian Treatment Outcome Profile (ATOP)
3. Patient Health Questionnaire – 9 (PHQ-9)
4. Generalized Anxiety Disorders – 7 (GAD-7)




Timepoint [1] 333643 0
Proportion of outcome measures completed at baseline, 1- and 3- month in the 12 months pre-and post-cluster enrolment in First Step
Primary outcome [2] 333644 0
Change in client primary drug of concern (PDOC) involvement score (PDOC use and associated problems) from baseline to 3-months follow up, assessed with the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in the standard care versus First Step clusters
Timepoint [2] 333644 0
Change in client PDOC involvement score from baseline to 3-months follow up in the 12 months pre-and post-cluster enrolment in First Step
Primary outcome [3] 333880 0
Number of clients who (i) receive verbal feedback from staff, (ii) open client feedback received or (iii) feedback from both sources on outcome measure surveys they have completed at baseline, one- and three-months follow up in the standard care versus First Step cluster

(i) Client receives verbal feedback from staff
Pre-measures:
Baseline or follow up outcome measure feedback: File audit (electronic and manual search of client case-note indicating the staff member discussed any outcome measure feedback with the client)

Post-measures:
Baseline outcome measure feedback: Google analytics (staff opened feedback) + First Step digital case note (any outcome measure component discussed with client)

Follow up outcome measure feedback: Google analytics (staff opened feedback &/or progress chart) + First Step digital case note (any outcome measure &/or progress chart component discussed with client)

(ii) Client receives client feedback
Pre-measures:
Baseline or follow up outcome measure feedback: Defined as per (i) above (no direct client feedback was available pre-First Step)

Post-measures:
Baseline: Google analytics (client opened feedback)
Follow up: Google analytics (client opened feedback &/or progress chart))

(iii) Client receives feedback from both sources
Defined as per (I) and (ii) above for pre- and post outcome measures at baseline and follow up
Timepoint [3] 333880 0
Proportion of clients who (i) receive verbal feedback from staff, (ii) receive and open client feedback or (iii) feedback from both sources on outcome measure surveys they have completed at baseline, one- and three-months follow up in the 6 months pre-and 12-months post-cluster enrolment in First Step
Secondary outcome [1] 417847 0
Number of clients who receive minimal staff-delivered verbal feedback on outcome measure surveys they have completed at baseline, 1- and 3-months follow up in the standard care versus First Step cluster.

Minimal staff feedback (yes/no): Yes, is defined as the discussion of the client’s pattern of substance use (frequency/quantity; ATOP), severity and related problems; and mental health symptoms defined as at least moderate levels of anxiety (GAD-7) or depression (PHQ-9) or a positive screen for suicide risk (item-9 of the PHQ-9), post-traumatic stress disorder (PC-PTSD) or psychosis (yes, to lifetime history question). Relevance is based on the results of the baseline, 1- and 3-month survey at that time point.

Pre-measures:
Baseline or follow up outcome measure feedback: File audit (electronic and manual search of client case-note indicating the staff member discussed minimal relevant outcome measure feedback with the client (defined above)

Post-measures
Baseline outcome measure feedback: First Step digital case note indicating minimal relevant outcome measure feedback discussed with the client (defined above)

Follow up outcome measure feedback: First Step digital case note indicating minimal relevant follow up outcome measure feedback discussed with the client (defined above)

Progress chart feedback: First Step case note indicating progress chart results were discussed with the client about their substance use and mental health symptoms over time
Timepoint [1] 417847 0
Proportion of clients who receive minimal staff-delivered verbal feedback on outcome measure surveys they have completed at baseline, 1- and 3-months follow up in the 6 months pre-and 12-months post-cluster enrolment in First Step
Secondary outcome [2] 417848 0
Change in client past 4-week frequency of primary drug of concern (PDOC) from baseline to 1- and 3 months follow up, assessed with the adapted version of the Australian Treatment Outcome Profile (ATOP) in the standard care versus First Step clusters


Timepoint [2] 417848 0
Change in client past 4-week frequency of PDOC from baseline to 1- and 3 months follow up in the 12 months pre-and post-cluster enrolment in First Step
Secondary outcome [3] 417849 0
Change in client past 4-week typical quantity of primary drug of concern (PDOC) from baseline to 1- and 3 months follow up, assessed with the adapted version of the Australian Treatment Outcome Profile (ATOP) in the standard care versus First Step clusters
Timepoint [3] 417849 0
Change in client past 4-week typical quantity of PDOC from baseline to 1- and 3 months follow up in the 12 months pre-and post-cluster enrolment in First Step
Secondary outcome [4] 417850 0
Change in client global substance use involvement score (composite score for alcohol and all other drugs) from baseline to 1- and 3-months follow up, assessed with the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) in the standard care versus First Step clusters
Timepoint [4] 417850 0
Change in client global substance use involvement score from baseline to 3 months follow up in the 12 months pre-and post-cluster enrolment in First Step
Secondary outcome [5] 417851 0
Change in client depression symptom severity from baseline to 1- and 3-months follow up, measured using the Patient Health Questionnaire (PHQ-9) in the standard care versus First Step clusters.
Timepoint [5] 417851 0
Change in client depression symptom severity from baseline to 1- and 3-months follow up n the 12 months pre-and post-cluster enrolment in First Step
Secondary outcome [6] 418608 0
Change in client anxiety symptom severity from baseline to 1- and 3-months follow up, measured using the Generalized Anxiety Disorder scale (GAD-7) in the standard care versus First Step clusters.
Timepoint [6] 418608 0
Change in client anxiety symptom severity from baseline to 1- and 3-months follow up n the 12 months pre-and post-cluster enrolment in First Step

Eligibility
Key inclusion criteria
All people (aged 18 to 80 years) who contact the participating drug and alcohol treatment services over the trial period will be included in the study.

Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any client enrolled in a program deemed not suitable for First Step (i.e. drug diversion) by the participating drug and alcohol treatment service or where drug and alcohol concerns are not their primary concern (i.e., gambling, family clients) will not be included

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)
The First Step brief intervention will be implemented over 12 months to eight geographical clusters of three service types (outpatient, residential and day programs) with approximately 1,000 clients in each cluster. A cluster RCT was chosen to allow First Step to be rolled out at each geographical cluster over time while preventing contamination effects across clusters. Clusters have been developed based on location to assist with training.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of the clusters will be conducted using a computer-generated, random allocation sequence by an external statistician
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Stepped-wedge cluster randomised trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be summarised using means and standard deviations (where continuous data is normally distributed), medians and interquartile ranges (where continuous data is non-normally distributed) and frequencies and percentages for proportions including 95% confidence intervals, as appropriate.

Preliminary logistic regressions will be undertaken to check for differences on demographic, primary and secondary outcomes between exposed (First Step) and unexposed (standard care) clusters. A similar analysis will be conducted to detect differences between those with missing data and those without missing data, on key baseline demographic and outcome variables. Any significant differences will be reported and controlled for wherever possible, to control for sampling bias and completion bias.

Primary outcomes: Exposed and unexposed clusters will be compared to determine whether there has been an increase in the proportion of outcome measures completed/feedback delivered to clients at baseline, one-month and three-months follow up. The effect of the intervention will be estimated using a logistic mixed-effect model. Completion of outcome measures at each time-point will be treated as a fixed effect and we will include random effects for treatment type, time within centre and individual within centre to account for the clustering, repeated measurements on centre and repeated measures on individuals, respectively. This technique can also control for potential confounds (e.g. demographic characteristics, baseline factors).

Secondary outcomes: Linear mixed effects models will be used to determine if there are i) changes over time in substance use and mental health outcomes between exposed (First Step) and unexposed (standard care) clusters at one-month and three-month follow up. Substance use and mental health at each time-point will be treated as a fixed effect and we will include random effects for cluster, treatment centre, and time to account for clustering of data within the RCT rollout clusters, treatment centres, and individuals, respectively.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/03/2023
Actual
Date of last participant enrolment
Anticipated
30/12/2023
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
9000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 39354 0
4000 - Brisbane
Recruitment postcode(s) [2] 39355 0
4217 - Gold Coast
Recruitment postcode(s) [3] 39356 0
4560 - Sunshine Coast
Recruitment postcode(s) [4] 39357 0
2500 - Wollongong
Recruitment postcode(s) [5] 39358 0
2800 - Orange
Recruitment postcode(s) [6] 39359 0
4700 - Rockhampton
Recruitment postcode(s) [7] 39360 0
4810 - Townsville
Recruitment postcode(s) [8] 39361 0
4870 - Cairns
Recruitment postcode(s) [9] 39362 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 313056 0
Government body
Name [1] 313056 0
National Health and Medical Research Council (NHMRC)
Country [1] 313056 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Lives Lived Well
Address
Level 1/55 Little Edward St, Spring Hill QLD 4000
Country
Australia
Secondary sponsor category [1] 314745 0
None
Name [1] 314745 0
Address [1] 314745 0
Country [1] 314745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312308 0
The University of Queensland HREC
Ethics committee address [1] 312308 0
Ethics committee country [1] 312308 0
Australia
Date submitted for ethics approval [1] 312308 0
Approval date [1] 312308 0
17/01/2023
Ethics approval number [1] 312308 0
2022/HE002235

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

Contacts
Principal investigator
Name 124190 0
Prof Leanne Hides
Address 124190 0
School of Psychology
The University of Queensland
St Lucia QLD 4072
Country 124190 0
Australia
Phone 124190 0
+61 406185750
Fax 124190 0
Email 124190 0
[email protected]
Contact person for public queries
Name 124191 0
Leanne Hides
Address 124191 0
School of Psychology
The University of Queensland
St Lucia QLD 4072
Country 124191 0
Australia
Phone 124191 0
+61406185750
Fax 124191 0
Email 124191 0
[email protected]
Contact person for scientific queries
Name 124192 0
Leanne Hides
Address 124192 0
School of Psychology
The University of Queensland
St Lucia QLD 4072
Country 124192 0
Australia
Phone 124192 0
+61406185750
Fax 124192 0
Email 124192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected at baseline and follow-up will be available upon request.
When will data be available (start and end dates)?
Anticipated start date: July 2024
End date: ongoing
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
Only to achieve the aims of the approved proposal.
How or where can data be obtained?
On request to the primary sponsor ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18134Study protocol  [email protected] Available upon request, post publication.
18135Statistical analysis plan  [email protected] Available upon request, post publication.
18136Ethical approval  [email protected] Available upon request
18137Analytic code  [email protected] Available upon request, post publication.



Results publications and other study-related documents

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