Trial document




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  DRKS00005035

Trial Description

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Title

Allocation of patients with alcohol use disorders to appropriate levels of care according to a decision algorithm based on a standardized intake assessment

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Trial Acronym

MATE-LOC

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URL of the Trial

http://zpm.uke.uni-hamburg.de/4DACTION/W_projekt_detail?L=P2&prn=581&tn=10&trn=3

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Brief Summary in Lay Language

Main purpose:
With this study we want to investigate whether patients can be assisted through targeted feedback even better in the choice of an appropriate follow-up and whether this leads to positive treatment outcomes. For the future, the treatment can be more precisely targeted to the individual needs of patients through the study. In the long term, the study will help optimizing the treatment of patients with substance use disorders and make the treatment options for patients more transparent.

Background:
In Germany there is a well-developed and effective support system for patients with substance use disorders. However, the various managers, organizational barriers, or the many available different treatment options may complicate the decision for further treatment. In other countries, positive experiences have been made when the treatment recommendation was based on criteria such as the severity of dependence, social and professional environment, comorbid mental disorders or the number of previous treatments. These systematic recommendations will be adapted to the individual needs of the patient.

Method:
After having given informed consent, patients take part in a 75-minute interview with the study staff. This interview occurs about one week after admission. Patients receive a questionnaire, which they can answer in about 30 minutes. It is about alcohol consumption and possible consequences of consumption for everyday life, both mental and physical healthas well as treatments the patients have been done. After the interview, patients are randomly assigned to one of two study conditions. In one condition, the patient may obtain a general feedback about the guided interview, the further treatment planning runs as it is usually the case in the clinic. In the second condition, the patient gets an additional appointment where he will be given a treatment recommendation, derived from the results of the interview.
Six months after the first interview, patients are called and asked to participate in a 40-minute telephone follow-up interview by a study staff. This conversation is about what happened to the patient after treatment. Questions are asked about areas that they have discussed in the first interview. To participate in this second interview, the patient will receive an allowance of € 30.00.

Study participants:
Patients with the primary diagnosis of alcohol dependence, which take par in a detoxification program, are eligible for the study. The patients shpuld have completed the physical detoxification, and have no serious cognitive deficits. Further treatment after withdrawal should not have been approved.

Objectives and hypotheses:
The aim of the study is the testing of allocation recommendations that are derived from a diagnostic interview and to compare these recommendations with natural allocation decisions for patient outcomes (consumption days within the last 30 days and number of elevated drinking days (operationalized as ≥ 6 standard drinks per day)) and health economic costs.
As hypotheses arise:
• Patients in the intervention group show six months after the end of treatment less alcohol consumption days (percent days) than patients in the control group.
• The cost of health care utilization are lower than in the patients of the control group, patients in the intervention group.

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Brief Summary in Scientific Language

Background:
In the Netherlands, the entire substance use treatment system has been restructured in the last 10 years. Allocation guidelines were implemented with positive results. Treatment recommendations could be derived from these guidelines that based on the criteria severity of dependence, severity, psychiatric comorbidity, severity of social disintegration and number of previous drug treatments (Merkx et al, 2007;, 2011). The allocation guidelines are based on the stepped-care principle, but also take into account criteria for the treatment needs of the client: four evidence-based, increasing in intensity treatment options can be derived, referred in the Dutch model as the level of care (LOC): outpatient short-term treatment (LOC 1), outpatient treatment (LOC 2), day hospital or inpatient (LOC 3) and long-term treatment (LOC 4). In order to capture the necessary guidelines for the allocation information systematically, a diagnostic interview, the Measurements in the Addictions for Triage and Evaluation (MATE; Schippers, 2010) was developed. In the Netherlands, both the MATE and the allocation guidelines have been implemented in almost all addiction services. There were positive results in terms of validity, cost-effectiveness and patient and practitioners acceptance (Merkx et al., 2011).
The potential benefits of Allocation Guidelines for the German addiction have frequently been discussed (eg Schulte, Shepherd & Reimer, 2003). While there are findings for differential allocation, such as the rehabilitation management categories (RMK, Spyra et al, 2011), there is no cross allocation guideline. However, the Dutch algorithm can not be applied unchanged in Germany, because both addiction systems differ substantially. For example, there is no (explicit) classification of different treatment options in terms of treatment intensity, also the German addiction treatment is more decentralized. The selection and weighting of indication criteria for various treatment options remains vague. Thus, a preliminary allocation guideline for the German substance use system was developed in the first phase of the study. In the second phase of the study it will be examined how the provisional guideline optimizes the allocation processes in the treatment of alcohol-dependent patients after detoxification.

Method:
The proposed project is the empirical testing of a newly developed allocation guideline for feasibility and impact on treatment success in patients after detoxification. The guideline is based on the assessment of disease-related characteristics that are elevated by using the MATE. As a result of the interview treatment recommendations can be made. The interview takes place after physical detoxification. To evaluate health economic costs, the Client sociodemographic and Service Receipt Inventory (CSSRI,. Chisholm et al, 2000) will be used and for the collection of health-related quality of life of the EQ-5D (Prieto et al, 2003) will be used. For the evaluating psychological aspects, the rehabilitation management category assessment will be applied (RMK; Sprya et al, 2011).
The interviews are conducted by specially trained therapists and last for about 75 minutes. Completion of the RMK- questionnaire will take 30 minutes.
The study is conducted as a randomized, controlled trial. Patients will be randomly assigned after completion of the interview either to intervention group or to control group. The computerized randomization is automatically, so that the interviewer at the end of the conversation gets a message indicating whether the patient belongs to the intervention or control group. Patients in the intervention group receive an additional appointment, a feedback session, in which the results of the interview and a treatment recommendation will be reported and discussed. The patients in the control group received a general outcome feedback on their problem areas and a recommendation to further treatment, as they are regularly discussed in the clinics, but not based on the MATE.
For the second measurement time, 6 months after the end of treatment, patients are interviewed by telephone by an employee at the UKE with the MATE- outcome. This interview takes about 45 minutes. Similarly, the CSSRI and the EQ-5D will be used.

Anticipated results:
In the present project an allocation guideline is checked for feasibility using the MATE. With this, patients in the intervention group after detoxification get recommendations for further treatment. A systematic and needs-based allocation of patients to further treatment has the potential to reduce long-term overuse, underuse and misuse. This may as well reduce costs in the health care system. Also, patients are spared treatments that do not meet their needs. The algorithm is designed to support practitioners thereby to derive treatment recommendations and to discuss those in a transparent manner with their patients. This in no way restricts the self-determination of the patient, but on the contrary increases the involvement of patients in the decision-making and their motivation for further treatment.
The allocation guideline will be empirically tested for its feasibility. This is done in four different located hospitals. Through the inclusion of several federal states and carrier (University Hospital, Regional Council, district hospital) a higher external validity and thus generalizability is to be expected. A randomized controlled trial of allocation guidelines has not yet been done, hence valuable methodological insights for the potency testing of systematic allocation methods are expected.

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Organizational Data

  •   DRKS00005035
  •   2013/06/03
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  •   yes
  •   Approved
  •   PV4325, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   VfD_MATE-LOC_12_001758  (Versorgungsforschung Deutschland)
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Health Condition or Problem studied

  •   F10 -  Mental and behavioural disorders due to use of alcohol
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Interventions/Observational Groups

  •   The patients get an 75-minute interview, which gives treatment recommendations (MATE, Schippers et al., 2011). This interview will take place one week after admission, when somatic detoxification has been done. To evaluate health care costs, the Client Sociodemographic and Service Receipt Inventory (CSSRI; Chisholm et al., 2000) will be applied. For evaluating psychological aspects the rehabilitee management categories will be given to the patient as questionnaire (RMK; Spyra et al., 2011). The EQ-5D will be applied to asses quality of life (Prieto et al., 2003). Patients of the intervention group and the clinical staff will receive a feedback session about the results and the MATE-LOC recommendations. A feedback session will take place with the interviewer and the patient where the results and the recommendationwill be explained to the patient. Interviewer and patient will discuss the results and both will agree on one treatment for the patient together.
  •   After completing a 75 minute interview (MATE; CSSRI; Chisholm et al., 2000; EQ-5D; Prieto et al., 2003) and a questionnaire (RMK; Sprya et al., 2011), patients of the control group and the clinical staff will receive a written evaluation of the general results of the MATE interview, if patients want to know, but without a standardized treatment recommendation. A treatment recommendation will be given to the patients as the therapists usually do.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Other
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- days of abstinence in terms of abstinent drinkers and days of heavy drinking (> 6 units per day) with the MATE at T0 and T1
- health economic costs with the CSSRI at T0 and T1

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Secondary Outcome

- feasibility of the procedure
- monitoring of the implementation of the MATE in the participating qualified detoxification programs
- feasibility of the use of the adapted MATE-algorithm for allocation decisions
- estimation of patients attrition
- estimation of compliance of therapist with the intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/06/09
  •   286
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Alcohol use disorder (dependence or misuse) as primary diagnosis,
2. Current treatment in an inpatient qualified detoxification program,
3. Completed medical detoxification,
4. cognitively and verbal ability to give consent to the study and to participate in the interview
5. voluntary participation

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Exclusion Criteria

1. Too low knowledge of the German language to take part in the study,
2. Being in treatment for reasons other than alcohol-related disorders,
3. Crisis intervention,
4. Acute psychosis,
5. Serious cognitive impairments,
6. Illiteracy,
7. Already approved treatment decision at intake

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf Insitut und Poliklinik für Medizinische Psychologie
    • Ms.  Dr. phil.  Angela  Buchholz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Institut für Therapieforschung
    • Mr.  Ludwig  Kraus 
    • Parzivalstr. 25
    • 80804  München
    • Germany
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    • Universitätsklinikum Freiburg Abteilung für Psychiatrie und Psychotherapie
    • Mr.  Dr. med.  Michael  Berner 
    • Hauptstrasse 5
    • 79104  Feriburg
    • Germany
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    • Universität Münster Abteilung für Klinische Psychologie
    • Mr.  Prof. Dr.  Fred  Rist 
    • Fliednerstraße 21
    • 4849  Münster
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf Institut und Poliklinik für Medizinische Psychologie
    • Ms.  Dr. phil.  Angela  Buchholz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf Institut und Poliklinik für Medizinische Psychologie
    • Ms.  Anke  Friedrichs 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/12/23
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Trial Publications, Results and other Documents

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