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Trial registered on ANZCTR
Registration number
ACTRN12626001007325
Ethics application status
Approved
Date submitted
14/07/2026
Date registered
17/08/2026
Date last updated
17/08/2026
Date data sharing statement initially provided
17/08/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Telehealth-delivered step-down for alcohol and other drug withdrawal:
The step-ahead project
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Scientific title
Telehealth-delivered step-down for alcohol and other drug withdrawal:
The step-ahead project
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Additional trial identifiers [1]
317888
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Withdrawal from alcohol
342833
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Withdrawal from other drugs
343019
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Condition category
Condition code
Mental Health
338949
338949
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0
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Addiction
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Public Health
339111
339111
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Step-down care for alcohol and other drug withdrawal: Patients who receive the step-down service will be assessed daily for suitability for discharge from hospital for community-based withdrawal completion by an addiction medicine specialist or psychiatrist, expected to be 1-3 days post admission, and transferred to non-inpatient care for the remainder of their withdrawal management by the service’s existing community health team. This team will manage the participant’s withdrawal until the completion of the withdrawal episode. Community-based treatment will be delivered by each site as clinically indicated based on local needs and service avaliability, and may include face to face or telehealth interventions. Care will be delivered by the site's multidisciplinary Drug and Alcohol teams, comprising of doctors, nurses, allied health professionals, and where available Aboriginal Health and Peer workers.
Withdrawal episodes are typically 5-7 days in duration, and will be delivered by specialist drug and alcohol services within NSW. Adherence will be monitored in terms of retention in care by review of medical records for each participant daily.
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Intervention code [1]
334733
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Treatment: Other
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Description of the comparator or control
This study is a stepped-wedge cluster randomised controlled trial. Each site will act as its own control. During the pre-intervention (i.e. control) period each site will deliver treatment per usual. Treatment as usual involves delivery of withdrawal management conventionally, usually over a 5-7 days admission to hospital with no formal step-down processes offered to patients.
The study comprises of 6 steps with a duration of 9 weeks each.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in hospital utilisation
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Assessment method [1]
346185
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Mean length of inpatient stay in hours. Length of stay will be extracted from routinely collected clinical data
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Timepoint [1]
346185
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Assessed at time of inpatient discharge
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Secondary outcome [1]
464920
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Feasibility of the model (composite outcome)
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Assessment method [1]
464920
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Total number of inpatient admissions over the study period (measured by the pre-screening log), total number of patients in this cohort eligible for the study (as deemed via pre-screening), total number of patients that opt to participate in the study (who consent and are formally screened and confirmed eligible), number of participating patients that choose to step-down as compared to complete withdrawal inpatient (count from medical records), length of stay for all participants in the study period (from medical records)
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Timepoint [1]
464920
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End of study (28 days post last patient baseline visit)
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Secondary outcome [2]
464921
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Withdrawal safety (i.e. seizure, readmission to hospital)
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Assessment method [2]
464921
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Withdrawal complications during the withdrawal episode extracted from participant medical records and emergency department representation within 48 hours post discharge from hospital
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Timepoint [2]
464921
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5 (+/-2) days post baseline (at time of admission), end of study (28 days post baseline)
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Secondary outcome [3]
464922
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Participant satisfaction
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Assessment method [3]
464922
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Satisfaction questionnaire (2 item visual analogue scale designed for this study)
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Timepoint [3]
464922
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5 (+/-2) days post baseline (at time of admission)
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Secondary outcome [4]
464924
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Duration of withdrawal treatment episode
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Assessment method [4]
464924
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Number of days from admission to end of treatment episode sourced from hospital records
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Timepoint [4]
464924
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Assessed at time of discharge
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Secondary outcome [5]
464925
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Withdrawal treatment completion
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Assessment method [5]
464925
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Proportion of clients who complete their withdrawal episode sourced from hospital records
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Timepoint [5]
464925
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Assessed at time of discharge
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Secondary outcome [6]
464927
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End of treatment substance use
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Assessment method [6]
464927
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Timeline followback via telephone interview
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Timepoint [6]
464927
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5 (+/-2) days post baseline (at time of admission)
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Secondary outcome [7]
464928
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Substance use, general health, wellbeing and clinical risks
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Assessment method [7]
464928
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Australian Treatment Outcomes Profile
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Timepoint [7]
464928
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End of study (28 days post baseline)
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Secondary outcome [8]
464929
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Engagement in post-withdrawal care
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Assessment method [8]
464929
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Engagement with ongoing care and concomitant medication use questionnaire designed for this study
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Timepoint [8]
464929
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End of study (28 days post baseline)
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Secondary outcome [9]
464930
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Acceptability of step-down inpatient withdrawal to patients (who engaged in step-down and decided not to engage in step-down) and staff (composite outcome)
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Assessment method [9]
464930
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Interview, semi-structured, telephone/video call delivered, audio recorded, approximately 30 minutes in duration
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Timepoint [9]
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Single time point, 5 to 28 days post baseline (following discharge)
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Secondary outcome [10]
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Cost-consequence analysis
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Assessment method [10]
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Overall cost, cost per treatment episode, change in average bed days pre- and post-implementation, proportion of service users eligible for step-down care and proportion of those eligible who elect to receive step-down care. Composite outcome sourced from hospital records
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Timepoint [10]
464931
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End of study (28 days post last patient baseline visit)
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Secondary outcome [11]
464932
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Acceptability and cultural safety for Aboriginal and Torres Strait Islander people accessing step-down treatment (composite outcome)
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Assessment method [11]
464932
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Aboriginal and Torres Strait Island peoples acceptability questionnaire (designed for this study) and qualitative interviews, semi-structured, telephone/video call delivered, audio recorded, approximately 30 minutes in duration
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Timepoint [11]
464932
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Questionnaire 5 (+/-2) days post baseline, interview 5 to 28 days post baseline (following discharge)
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Eligibility
Key inclusion criteria
Participants will be eligible to participate in this study if they:
• have been admitted to a participating withdrawal management unit,
• are 18 years of age or over,
• are willing to be followed up post withdrawal episode, and
• are willing to provide written informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Participants will be excluded if they:
• Do not meet the Eligibility criteria for consideration of step-down from inpatient to non-inpatient withdrawal management in public withdrawal management units in NSW
• Primary substance of concern for withdrawal is a benzodiazepine
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Stepped-wedge cluster randomised controlled trial. This study employs a stepped-wedge design, where each of the five participating services will be randomly allocated to begin the intervention at different times.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data from our records indicate that 1 participant per week per site will be a realistic recruitment rate for the study and that the average time in treatment with the current method is 5.0±1.9 days. Clinical experience suggests that (a) the average stay using the step-down method is approximately 2 days, (b) approximately 30% of eligible participants offered step-down care will take it.
Thus, the estimated difference between average Pre-intervention length of stay and average Post-intervention length of stay = 5.0 – (5.0*(1-0.3) + 2*0.3) = 5 – 4.1 = 0.9 days, representing a medium standardised effect size of d = 0.9/1.9 = 0.47.
1-2 participants recruited per week at each of 5 sites, for 54 weeks, equals 336 participants (168 in the pre-intervention period and 168 in the post-intervention period). Assuming a conservative intracluster correlation coefficient (ICC) of 0.04, the study will have 85% power to detect a difference in average length of stay between the pre- and post-intervention period of 0.9 days.
Analysis:
All analyses will be conducted using Bayesian parameter estimation, which estimates proportion of probability density falling within a predefined interval and hence allows for estimates of equality as well as difference. The primary outcome, length of stay (one observation per participant), will be analysed with a Level-1, hierarchical repeated measures regression model, with fixed factors Study Period (binary within-site categorical variable, pre-intervention vs postintervention) and primary drug of concern, age, gender, postcode of residence SEIFA rank, (covariates) and random factor site (six-level categorical variable indicating Site ID).
Other single-observation outcomes (e.g. completion of withdrawal treatment) will be analysed with single-level (i.e. non-hierarchical) regression with predictors care type (binary between-subject categorical predictor: standard care vs step-down care) and covariates principle drug of concern, age, gender, and SEIFA rank Some single-observation outcomes will be analysed using both the hierarchical and single-level models described above.
Numeric outcomes (e.g. the primary outcome, length of stay, withdrawal score) will be analysed using standard Gaussian regression, binary categorical outcomes (e.g. withdrawal episode completion) with Bernoulli regression, bounded count outcomes (i.e. where count has upper limit e.g. days of substance use at follow up) with binomial regression, and unbounded counts (i.e. where count has no known limit, e.g. adverse events) with Poisson or negative binomial regression. Time to event data (e.g. mortality) will be analysed with Cox Proportional Hazards regression.
Qualitative analysis:
Qualitative interviews will be transcribed and coded using a conventional content analysis approach. Data will be analysed according to a Theoretical Framework of Acceptability (TFA), which consists of seven component structures which influence how a person accepts healthcare interventions.
For First Nations interviews thematic framework analysis will assess emerging themes in the data. Qualitative analysis of the interviews will be conducted under the supervision of First Nations Investigators.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2026
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Actual
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Date of last participant enrolment
Anticipated
14/09/2027
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Actual
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Date of last data collection
Anticipated
12/10/2027
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Actual
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Sample size
Target
336
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
29822
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [2]
29823
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Concord Repatriation Hospital - Concord
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Recruitment hospital [3]
29824
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Belmont Hospital - Belmont
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Recruitment hospital [4]
29825
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Lismore Base Hospital - Riverlands Drug & Alcohol Service - Lismore
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Recruitment hospital [5]
29826
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Nepean Hospital - Kingswood
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Recruitment postcode(s) [1]
46174
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
46175
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2139 - Concord
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Recruitment postcode(s) [3]
46176
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2280 - Belmont
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Recruitment postcode(s) [4]
46177
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2480 - Lismore
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Recruitment postcode(s) [5]
46178
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2747 - Kingswood
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NSW Ministry of Health
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Address [1]
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Country [1]
322427
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
325350
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None
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Name [1]
325350
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None
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Address [1]
325350
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Country [1]
325350
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
320921
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St Vincent’s Hospital Human Research Ethics Committee
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Ethics committee address [1]
320921
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https://svhs.org.au/home/research-education/research-office
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Ethics committee country [1]
320921
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Australia
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Date submitted for ethics approval [1]
320921
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24/11/2025
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Approval date [1]
320921
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16/01/2026
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Ethics approval number [1]
320921
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Summary
Brief summary
Inpatient withdrawal management provides highly supportive care to allow people to safely and successfully complete their withdrawal episode. This duration of hospitalisation is of significant burden, both at the individual level and health system level. Expert consensus from the Clinical Directors of the five Local Health Districtss involved in this project have identified a potential solution – providing the option of a step-down model of care for patients admitted to hospital for alcohol and/or drug withdrawal. Based on clinical risk assessment, this would allow for patients to complete withdrawal in the community, reducing burden on hospital beds and allowing people to receive care from their own homes with access to personal supports. This project seeks to evaluate the impact of this change on length of stay and clinical outcomes using a stepped-wedge trial design where hospitals will randomly begin offering step-down care as an option to their patients over a 54 week period.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Liam Acheson
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Address
152078
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St Vincent's Hospital, 390 Victoria St Darlinghurst NSW 2010
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Country
152078
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Australia
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Phone
152078
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+61 2 9065 7809
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Fax
152078
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Email
152078
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[email protected]
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Contact person for public queries
Name
152079
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Liam Acheson
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Address
152079
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St Vincent's Hospital, 390 Victoria St Darlinghurst NSW 2010
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Country
152079
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Australia
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Phone
152079
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+61 2 9065 7809
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Fax
152079
0
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Email
152079
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[email protected]
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Contact person for scientific queries
Name
152080
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Liam Acheson
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Address
152080
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St Vincent's Hospital, 390 Victoria St Darlinghurst NSW 2010
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Country
152080
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Australia
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Phone
152080
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+61 2 9065 7809
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Fax
152080
0
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Email
152080
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
STEP-AHEAD approval letter.pdf
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.
Download to PDF