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Implementation of 'First step' into Alcohol and Drug Services – A stepped-wedge cluster randomised trial

Effect of the implementation of 'First step' into Alcohol and Drug Services on service delivery – A stepped-wedge cluster randomised trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000254695
Enrollment
9000
Registered
2023-03-09
Start date
2023-03-10
Completion date
2023-12-30
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The demand for alcohol and other drug (AOD) treatment in Australia, greatly outweighs the resources available. Consequently, AOD services tend to prioritize the volume of service delivery over quality. Value-based models of healthcare, which shift the focus away from the volume of service delivery, towards achieving the best possible client outcomes relative to the resources and costs required (value), provide a potential solution to these problems. Outcome measures are at the cornerstone of value-based health care. Over the past 6 years we have worked with our industry partner to (i) identify the core outcome measures (COM) that matter to clients and staff; (ii) identify and address individual, organizational and system barriers to their adoption and (iii) develop a novel online system that collects client self-report COM data and provides automatic feedback to staff and clients at service entry, 1 and 3 months follow up. However, there is still plenty of room for improvement in the uptake of COMs and the delivery of feedback to clients. Based on our previous successful research trial (see First Step ACTRN12621000467831) our industry partner has decided to implement this brief intervention as the first step of treatment to to clients across all of their services. Since outcome measures and feedback are part of Module 1 of First Step, it is an opportune time to determine the impact of our refined outcome measure and feedback training and implementation processes on their level of uptake by staff and clients. The client outcomes of the First Step brief intervention are also yet to be evaluated in a RCT. This study will conduct a stepped-wedge, cluster randomised trial to determine the impact of the outcome measure and feedback training and implementation processes delivered as part of the First Step trial on their level of uptake by staff and clients. The client outcomes of First Step at one and three months follow up will also be evaluated in this trial using the routinely collected de-identified outcome measure data. There are two main objectives of this study. 1. The overall objective of the study is to evaluate the impact of the outcome measure and feedback training and implementation process on the proportion of clients who complete outcome measures and receive feedback at baseline, one month and three months 2. Determine if the First Step brief intervention is more efficacious for improving client substance use, mental health, and quality of life outcomes than standard AOD care at one- and three- months follow up

Interventions

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 w

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.

Sponsors

Lives Lived Well
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026