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Assertive Community Treatment for Patients Suffering From Substance Use Disorders

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ClinicalTrials.gov Identifier: NCT03623178
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Louise Penzenstadler, University Hospital, Geneva

Brief Summary:
According to the World Health Organization the population suffering from addiction problems is increasing. This population is characterized by multiple needs at the medico-psychosocial level. However, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs. Persons with substance use disorder often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis. These individuals also show very low utilization of health care services, accompanied by social marginalization. This can be related to relapses and poor social functioning. A high number of relapses occur particularly at the end of hospitalization. Community Interventions, such as Assertive Community Treatment (ACT) should increase the adherence of these patients to treatment by accompanying them in the community and helping them during sensitive and crisis periods. One of the objectives of the study is to evaluate the impact of ACT on the time until service disengagement, measuring treatment adherence. The secondary objectives of this study will be to see the effect of ACT on duration and type of hospitalizations, as well as the number of emergency room visits. The investigators will focus on the impact of ACT on the participant's medico-psycho-social network, substance use and other psychological variables. The investigators will also evaluate his or her psychiatric symptoms and global and social functioning. Life satisfaction and satisfaction with the care received will also be measured. The investigators will compare the population treated with ACT with sex, age and substance-matched controls which do not respond to ACT inclusion criteria chosen from new admissions of our addictology consultation. The study will investigate this through questionnaires at the beginning of care, at three months, six months and 12 months after the start of the ACT intervention.

Condition or disease Intervention/treatment
Substance Use Disorders Other: Assertive Community Treatment Other: Treatment As Usual

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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Assertive Community Treatment for Patients Suffering From Substance Use
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : April 1, 2019

Group/Cohort Intervention/treatment
Assertive Community Treatment

patients with DSM-5 Diagnosis of SUD and one of the following criteria (1) present important functional difficulties, in at least one of the following areas: everyday life activities and maintaining a supportive social network, for minimum two years.

or (2) difficulties to attend their health care appointments, during the last 3 months.

Other: Assertive Community Treatment
The intervention program is a type of very flexible community treatment. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialized in SUD treatment. The time of the intervention differs, there is no prefixed limitation but the duration of the intervention depends on the goals agreed on with the patient. The main objective of this intervention is to ensure an adherence to an addiction treatment program and establish or consolidate a stable healthcare and social network for the patient. The intervention aims to prevent service disengagement. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs.

Treatment As Usual
patients with DSM-5 Diagnosis of SUD which do not respond to ACT inclusion criteria
Other: Treatment As Usual
The treatment as usual is the intervention given in our outpatient addictology unit. It consists of an individual treatment program at our outpatient unit with regular appointments with psychiatrists and nurses. The patient can also take part in therapeutic groups and receive help from a psychologist for a targeted program or psychotherapy. The multidisciplinary team also comprises a social worker and an occupational therapist.




Primary Outcome Measures :
  1. Treatment adherence [ Time Frame: at 12 months ]
    Number of days until service disengagement


Secondary Outcome Measures :
  1. Service use [ Time Frame: at 12 months ]
    Number of hospital admissions and number of days in hospital

  2. Patient network [ Time Frame: 0, 3, 6, 12 months ]
    Number of persons in network

  3. Number of ER visits [ Time Frame: 0, 3, 6, 12 months ]
    Number of ER visits reviewed on patient file

  4. Addictive behaviour [ Time Frame: 0, 3, 6, 12 months ]
    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST. V.3 French)

  5. General psychiatric symptoms [ Time Frame: 0, 3, 6, 12 months ]
    Health of Nation Outcome Scale - French version (HoNOS-F): scores 0 - 52 (higher score = more psychiatric symptoms)

  6. Global Functioning [ Time Frame: 0, 3, 6, 12 months ]
    World Health Organization Disability Assessment Schedule (WHODAS)

  7. General life satisfaction: Satisfaction With Life Scale [ Time Frame: 0, 3, 6, 12 months ]
    Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction)

  8. Advance directives written by the participant [ Time Frame: at Baseline ]
    Advance directives written by the participant (yes - no)


Other Outcome Measures:
  1. Patient satisfaction with Assertive Community Treatment [ Time Frame: at 3, 6, 12 months ]
    Patient satisfaction with Assertive Community Treatment (very satisfied, satisfied, more or less satisfied, not satisfied

  2. Duration of Assertive Community Treatment intervention [ Time Frame: at 12 months ]
    Daily contact log (Relevé quotidien des contacts (RQC)) in minutes spent with patient

  3. Type of Assertive Community Treatment intervention [ Time Frame: at 12 months ]
    Daily contact log (Relevé quotidien des contacts (RQC)): documentation of type of activity done with patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subgroup of high need users with difficulties in engaging in substance use disorder treatment.
Criteria

Inclusion Criteria:

  • Substance use disorder
  • Competent subjects, able to give informed consent
  • French speaking

Exclusion Criteria:

  • Evidence of organic brain disease or learning disability based on the chart review.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623178


Contacts
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Contact: Louise Penzenstadler, MD +41 22 3725750 Louise.E.Penzenstadler@hcuge.ch
Contact: Yasser Khazaal, Prof Yasser.Khazaal@hcuge.ch

Locations
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Switzerland
Service d'addictologie, HUG Recruiting
Geneva, Switzerland, 1202
Contact: Louise Penzenstadler, MD    +41 22 3725750    Louise.E.Penzenstadler@hcuge.ch   
Contact: Yasser Khazaal, Prof       Yasser.Khazaal@hcuge.ch   
Sub-Investigator: Carina Soares         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Louise Penzenstadler, MD University Hospital, Geneva

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Responsible Party: Louise Penzenstadler, Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03623178     History of Changes
Other Study ID Numbers: ID 2017-01087
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Louise Penzenstadler, University Hospital, Geneva:
Substance Use Disorders
Assertive Community Treatment
Community Treatment
Treatment engagement
Service Use

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders