Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001107415
Ethics application status
Approved
Date submitted
8/08/2016
Date registered
16/08/2016
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving alcohol treatment outcomes: The effect of individual patient characteristics, treatment and system variables on alcohol treatment outcomes in patients attending specialist alcohol treatment service.
Scientific title
Improving alcohol treatment outcomes: The effect of individual patient characteristics, treatment and system variables on alcohol treatment outcomes in patients attending specialist alcohol treatment service.
Secondary ID [1] 289635 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction 299426 0
Alcoholism 299428 0
Condition category
Condition code
Mental Health 299408 299408 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
Clients will be asked to complete an iPad survey at baseline while waiting for their appointment at the clinic. A telephone survey will be completed at 3 months follow up. The primary outcome measure will be the number of heavy drinking days (> 5 drinks per day) in past 14 days.
Secondary outcome measures will include the number of drinking days; total alcohol consumption; and health related quality of life. Predictor variables will include client (e.g. demographics, substance use), intervention (e.g. treatment type), and system-­level variables (e.g. process of care). The relationship between predictor and outcome variables will be examined within a multilevel modelling framework.
Intervention code [1] 295250 0
Not applicable
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298884 0
Number of heavy drinking days (>5 drinks per day) in the previous 2 week. This question is part of a survey designed specifically for this study
Timepoint [1] 298884 0
Baseline and 3 months post-recruitment
Primary outcome [2] 298984 0
Number of drinking days in the past 2 weeks. This question is part of a survey designed specifically for this study
Timepoint [2] 298984 0
Baseline and 3 month post-recruitment
Primary outcome [3] 298985 0
Total alcohol consumption in the previous 2 weeks. This question is part of a survey designed specifically for this study
Timepoint [3] 298985 0
Baseline and 3 month post-recruitment
Secondary outcome [1] 325818 0
Severity of alcohol dependence measured by Audit C
Timepoint [1] 325818 0
3 months post-recruitment
Secondary outcome [2] 325819 0
Health-related quality of life measured by SF-8
Timepoint [2] 325819 0
Baseline and 3 months post-recruitment
Secondary outcome [3] 325820 0
Other drug use as measure by ATOP
Timepoint [3] 325820 0
Baseline and 3 months post-recruitment
Secondary outcome [4] 325821 0
Treatment provided for withdrawal measured by a client medical record audit.
Timepoint [4] 325821 0
3 months post-recruitment
Secondary outcome [5] 326743 0
Type of treatment provided for withdrawal measured by client medical record audit.
Timepoint [5] 326743 0
3 months post-recruitment
Secondary outcome [6] 326744 0
Proposed and actual length of treatment for withdrawal measured by clinical medical record audit
Timepoint [6] 326744 0
3 months post-recruitment
Secondary outcome [7] 326745 0
Characteristics of treatment episodes measured by clinical medical record audit
Timepoint [7] 326745 0
3 months post-recruitment
Secondary outcome [8] 326746 0
Adherence to pharmacotherapies measured by clinical medical record audit
Timepoint [8] 326746 0
3 months post-recruitment
Secondary outcome [9] 326747 0
Quality of the therapeutic relationship measured by the Working Alliance Inventory in the client follow-up and staff survey.
Timepoint [9] 326747 0
3 months-post recruitment for clients and once 50% of clients have been recruited from centre
Secondary outcome [10] 326748 0
Use of biological confirmation of abstinence as part of treatment measured by clients medical record audit
Timepoint [10] 326748 0
3 months post-recruitment
Secondary outcome [11] 326749 0
Staff turn over. This question is part of a survey designed specifically for this study to measure system variables
Timepoint [11] 326749 0
50% of clients have been recruited from centre
Secondary outcome [12] 326750 0
Staff supervision. This question is part of a survey designed specifically for this study to measure system variables
Timepoint [12] 326750 0
50% of clients have been recruited from centre
Secondary outcome [13] 326751 0
Number and type of peripheral services. These questions are part of a survey designed specifically for this study to measure system variables
Timepoint [13] 326751 0
50% of clients have been recruited from centre
Secondary outcome [14] 326752 0
Teaching status. This question is part of a survey designed specifically for this study to measure system variables
Timepoint [14] 326752 0
50% of clients have been recruited from centre
Secondary outcome [15] 326753 0
Continuity of care. These questions are part of a survey designed specifically for this study to measure system variables
Timepoint [15] 326753 0
50% of clients have been recruited from centre
Secondary outcome [16] 326754 0
Participation in clinical trials. This question is part of a survey designed specifically for this study to measure system variables
Timepoint [16] 326754 0
50% of clients have been recruited from centre
Secondary outcome [17] 326755 0
Geographic location. This question is part of a survey designed specifically for this study to measure system variables
Timepoint [17] 326755 0
50% of clients have been recruited from centre
Secondary outcome [18] 326756 0
Funding type. This question is part of a survey designed specifically for this study to measure system variables
Timepoint [18] 326756 0
50% of clients have been recruited from centre
Secondary outcome [19] 326757 0
Number of clients treated per year. This question is part of a survey designed specifically for this study to measure system variables
Timepoint [19] 326757 0
50% of clients have been recruited from centre
Secondary outcome [20] 326758 0
Organisation accreditation. This question is part of a survey designed specifically for this study to measure system variables
Timepoint [20] 326758 0
50% of clients have been recruited from centre
Secondary outcome [21] 326759 0
Team climate. These questions are part of a survey designed specifically for this study to measure system variables
Timepoint [21] 326759 0
50% of clients have been recruited from centre
Secondary outcome [22] 326760 0
Perceived team effectiveness. These questions are part of a survey designed specifically for this study to measure system variables
Timepoint [22] 326760 0
50% of clients have been recruited from centre
Secondary outcome [23] 326761 0
Continuing education. These questions are part of a survey designed specifically for this study to measure system variables.
Timepoint [23] 326761 0
50% of clients have been recruited from centre
Secondary outcome [24] 326762 0
Skills and qualifications. These questions are part of a survey designed specifically for this study to measure system variables.
Timepoint [24] 326762 0
50% of clients have been recruited from centre
Secondary outcome [25] 326763 0
Implementation of evidence-based practice. These questions are part of a survey designed specifically for this study to measure system variables.
Timepoint [25] 326763 0
50% of clients have been recruited from centre
Secondary outcome [26] 326764 0
Commitment to quality improvement. These questions are part of a survey designed specifically for this study to measure system variables.
Timepoint [26] 326764 0
50% of clients have been recruited from centre
Secondary outcome [27] 326765 0
Staff performance management. These questions are part of a survey designed specifically for this study to measure system variables.
Timepoint [27] 326765 0
50% of clients have been recruited from centre
Secondary outcome [28] 326766 0
Demographics and social functioning. These questions are part of a survey designed specifically for this study to measure client variables.
Timepoint [28] 326766 0
3 months post-recruitment

Eligibility
Key inclusion criteria
Clients:
(i) aged 18 years or older; (ii) presenting for new episode of treatment at the participating service; (iii) have nominated alcohol as their primary drug of concern; (iv) have used alcohol in the past 30 days; (v) have not previously been enrolled in the study in the last 6 months; and (vi) have a telephone contact number.

Staff:
All staff from participating centres will be invited to contribute to the study if they are employed in the alcohol treatment clinic and are involved in providing direct patient care.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Additionally, the study is focusing on those treatment centres community-based providing alcohol treatment to adults. Centres are ineligible if they are services that provide withdrawal only, residential rehabilitation only, detoxification services only and/or treat less than 50 clients for alcohol as primary drug of concern in 12 months (or approximately less than 75 episodes). Participants under the age of 18 have been excluded as they are unable to give informed consent. While non­-English speaking groups represent an important segment within the target population, translation costs for study materials will make it cost prohibitive to include this group in the current study.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/08/2016
Actual
22/12/2016
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
31/07/2019
Actual
Sample size
Target
7250
Accrual to date
723
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294084 0
Government body
Name [1] 294084 0
National Health and Medical Research Council
Country [1] 294084 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 292914 0
None
Name [1] 292914 0
Address [1] 292914 0
Country [1] 292914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295500 0
Hunter New England Hunman Research Ethics Committe
Ethics committee address [1] 295500 0
Lookout Road
New Lambton NSW 2305
Australia
Ethics committee country [1] 295500 0
Australia
Date submitted for ethics approval [1] 295500 0
29/04/2016
Approval date [1] 295500 0
11/07/2016
Ethics approval number [1] 295500 0
16/05/18/4.07/ HREC/16/HNE/193

Summary
Brief summary
Patient outcomes can be significantly influenced by the characteristics of the system in which health care services are delivered, independently of patient and treatment characteristics. There has been no systematic examination of the relative impact of client, treatment and systems ­level variables on outcomes for alcohol dependence. This study aims to determine, using a prospective cohort study, the impact of: (a) individual client characteristics; (b) type of treatment; and (c) features of the system in which treatment is provided, on alcohol treatment outcomes. Eligible treatment centres will be those that provides a face­to­face specialist outpatient alcohol treatment service to adults and expect to treat at least 50 clients for alcohol as primary drug of concern in the next 12 months (or approximately 75 episodes). Fifty services across Australia will be recruited using stratified sampling. Eligible clients will be aged 18 years or older; presenting for a new episode of outpatient treatment at the service; have nominated alcohol as their primary drug of concern; have used alcohol in the last 30 days; have not previously been enrolled in the study in the last 6 months; and have a telephone contact number. Clients will be asked to complete an iPad survey at baseline while waiting for their appointment at the clinic. A telephone survey will be completed at 3 months follow up. The primary outcome measure will be the number of heavy drinking days (> 5 drinks per day) in past 14 days. Secondary outcome measures will include the number of drinking days; total alcohol consumption; and health related quality of life. Predictor variables will include client (e.g. demographics, substance use), intervention (e.g. treatment type), and system ­level variables (e.g. process of care). The relationship between predictor and outcome variables will be examined within a multilevel modelling framework. This is the first study internationally to examine the role of three levels of variables on treatment success. It will provide critical information for policy makers on which to base minimum service standards. Clinic Staff will be invited to participate in a web-based survey, from the Director (or delegate) of their clinic providing information about their own qualifications and skills, their role in relation to the delivery of client treatment, and their perceptions about staff attitudes, team culture and client relationship within the clinic, implementation of evidence-based practice and commitment to quality improvement. One key informant from the centre will be asked to participate in a telephone interview to obtain information number and type of staff, staff turnover, staff supervision, number and type of peripheral services, teaching status, continuity of care, participation in clinical trials, geographic location, funding type, number of clients treated per year, organisational accreditation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67270 0
Prof Robert Sanson-Fisher
Address 67270 0
W4 HMRI Building
University of Newcastle
University Drive
Callaghan NSW 2308
Country 67270 0
Australia
Phone 67270 0
+61240420713
Fax 67270 0
Email 67270 0
[email protected]
Contact person for public queries
Name 67271 0
Dr Megan Freund
Address 67271 0
W4 HMRI Building
University of Newcastle
University Drive
Callaghan NSW 2308
Country 67271 0
Australia
Phone 67271 0
+6124040834
Fax 67271 0
Email 67271 0
[email protected]
Contact person for scientific queries
Name 67272 0
Prof Robert Sanson-Fisher
Address 67272 0
W4 HMRI Building
University of Newcastle
University Drive
Callaghan NSW 2308
Country 67272 0
Australia
Phone 67272 0
+61240420713
Fax 67272 0
Email 67272 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


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23450Ethical approvalImproving alcohol treatment outcomes: The impact of client, intervention and system variables on treatment outcomes (16/05/18/4.07)   371053-(Uploaded-11-11-2020-13-15-16)-Study-related document.pdf
23451Study protocol    371053-(Uploaded-11-11-2020-13-17-24)-Study-related document.docx

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4025Plain language summaryNo N/A

Documents added automatically
No additional documents have been identified.