Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000599976
Ethics application status
Approved
Date submitted
8/06/2011
Date registered
9/06/2011
Date last updated
9/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effective aftercare for patients with substance abuse who have been court-ordered to involuntary care.
Scientific title
The use of case management to promote abstinence and linkage to care in patients with substance abuse who have been court-ordered to care.
Secondary ID [1] 262331 0
Nil
Universal Trial Number (UTN)
U1111-1122-0303
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance abuse 268036 0
Condition category
Condition code
Mental Health 268167 268167 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Case management according to Comprehensive Case Management for Substance Abuse Treatment,
Treatment Improvement Protocol (TIP) Series 27. U.S. Department of Health and Human Services.
The case manager and patient assessed the situation using ten different instruments. The case manager, patient, social worker and institutional staff planned the interventions for the first six months in aftercare. The case manager and patient met at least once a week to plan for the week. The case manager monitored the plans together with patient. The case manager, patient and social worker met with social worker once a month to plan interventions.
The case manager sent in description of interventions to project leader once a week and got weekly feed-back on adherence to manual. Interventions were according to plan and could include relapse intervention, visit to psychiatric out-patient unit, coffee with relatives etc.
Intervention code [1] 266722 0
Behaviour
Intervention code [2] 266728 0
Rehabilitation
Comparator / control treatment
Treatment as usual; Conference with patient, social worker and staff at the institution in order to assess and plan for aftercare. Aftercare interventions according to plan which could include conference with social worker once a week to once a month.
Control group
Active

Outcomes
Primary outcome [1] 266911 0
Abstinence was measured by the following questionnaires; Time-Line-Follow-Back (TLFB), Alcohol Use Disorders Identification test (AUDIT), The Addiction Severity Index (ASI) and by a predecessor to Drug Use Identification Test (AUDRUG).
Timepoint [1] 266911 0
After intervention and 6 months follow-up
Secondary outcome [1] 276608 0
Linkage to care; access to out-patient hospital care, in-patient hospital care, social servicesand institutional care. Patients and significant others were asked during interview to specify which type of care the patient had had access to in aftercare.
Timepoint [1] 276608 0
After intervention and 6 months follow-up

Eligibility
Key inclusion criteria
Court-order to involuntary care, residency in one of nine municipalities, involuntary care in one of three institutions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria.

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)
At intake the patient was provided with written and oral information about the study by a research assistant. After consent to participation the patient was interviewed by the research assistant. After the interview the patient was allocated to intervention.
The person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated. Allocation was concealed and performed after information on five variables was sent to an administrator off-site. The administrator used a computerized system - urn randomization (reference: Stout RL, Wirtz PW, Carbonari JP, Del Boca FKJ. Ensuring balanced distribution of prognostic factors in treatment outcome research. Journal of Studies of Alcohol. Supplement, 1994: 12, 70-75).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By a computer-based urn randomization(Stout RL, Wirtz PW, Carbonari JP, Del Boca FKJ. Ensuring balanced distribution of prognostic factors in treatment outcome research. Journal of Studies of Alcohol. Supplement, 1994: 12, 70-75. The covariates used in the system were: age groups (18-24, 25-39, 40-), gender (men, women), housing (yes, no), substance abuse (alcohol, heroin, others) and MADRS (0-7 points, 8-10 points).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 3616 0
Sweden
State/province [1] 3616 0
Skane

Funding & Sponsors
Funding source category [1] 267206 0
Government body
Name [1] 267206 0
Ministry of Health and Social Affairs Task Force - Mobilize against Drugs
Country [1] 267206 0
Sweden
Funding source category [2] 267207 0
Government body
Name [2] 267207 0
County administration Lansstyrelsen i Skane lan
Country [2] 267207 0
Sweden
Funding source category [3] 267208 0
Government body
Name [3] 267208 0
The National Board of Institutional Care
Country [3] 267208 0
Sweden
Primary sponsor type
University
Name
Marianne Larsson Lindahl
Address
Clinical Alcohol Research, 108 Skane University Hospital-Malmo, 20501 Malmo
Country
Sweden
Secondary sponsor category [1] 266277 0
None
Name [1] 266277 0
Address [1] 266277 0
Country [1] 266277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269198 0
Regional Ethical Review Board
Ethics committee address [1] 269198 0
Box 133
221 00 LUND
Ethics committee country [1] 269198 0
Sweden
Date submitted for ethics approval [1] 269198 0
Approval date [1] 269198 0
06/02/2003
Ethics approval number [1] 269198 0
LU 955-02, Li 03-002

Summary
Brief summary
This is one of very few randomised trials on case management in a European setting. It examined the impact of case management on substance abuse and access to treatment after discharge from court-ordered institutional care. Court-ordered patients with substance abuse (n=36) were randomly assigned to either case management or treatment-as-usual during six months in aftercare. Data was collected at intake, at conclusion of intervention and at 6 month’s follow-up with a follow-up rate of 97%. Significant others and social workers were interviewed about the patients' need and use of care at intake and during aftercare. Significantly more patients in the case management group were abstinent during intervention. No differences were detected in regard to access to care between study groups. A subgroup analysis showed that patients with a continuous drug abuse had greater access to care and significantly more days in inpatient care. Our findings suggest that case management is useful in order to retain abstinence in aftercare following court-ordered treatment. The social welfare and hospital care systems seem to provide care irrespective of case manager-intervention. The study design, interventions and assessments instruments were well received by patients with 90% consent to participation but needs to be replicated with a larger population.
Trial website
Trial related presentations / publications
Presentation: International Academy of Law and Mental Health (2005) Paris, France. International Academy of Law and Mental Health (2007) Padua, Italy. International conference on Health promoting hospitals and health services (2011) Turku, Finland.
Publication: Case management in aftercare of
court-ordered substance abusers. A randomised trial. (submitted)
Public notes

Contacts
Principal investigator
Name 32711 0
Address 32711 0
Country 32711 0
Phone 32711 0
Fax 32711 0
Email 32711 0
Contact person for public queries
Name 15958 0
Marianne Larsson Lindahl
Address 15958 0
Clinical Alcohol Research,
108 Skane University Hospital-Malmo,
205 02 Malmo
Country 15958 0
Sweden
Phone 15958 0
+4640336965
Fax 15958 0
Email 15958 0
marianne.larsson_lindahl@med.lu.se
Contact person for scientific queries
Name 6886 0
Marianne Larsson Lindahl
Address 6886 0
Clinical Alcohol Research,
108 Skane University Hospital-Malmo,
205 02 Malmo
Country 6886 0
Sweden
Phone 6886 0
+4640336965
Fax 6886 0
Email 6886 0
marianne.larsson_lindahl@med.lu.se

No information has been provided regarding IPD availability


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Results publications and other study-related documents

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