Assertive Community Treatment for Patients Suffering From Substance Use Disorders

Sponsor
University Hospital, Geneva (Other)
Overall Status
Unknown status
CT.gov ID
NCT03623178
Collaborator
(none)
66
1
16
4.1

Study Details

Study Description

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 Phase
  • Other: Assertive Community Treatment
  • Other: Treatment As Usual

Study Design

Study Type:
Observational
Anticipated 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 :
Dec 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Treatment adherence [at 12 months]

    Number of days until service disengagement

Secondary Outcome Measures

  1. Service use [at 12 months]

    Number of hospital admissions and number of days in hospital

  2. Patient network [0, 3, 6, 12 months]

    Number of persons in network

  3. Number of ER visits [0, 3, 6, 12 months]

    Number of ER visits reviewed on patient file

  4. Addictive behaviour [0, 3, 6, 12 months]

    Alcohol, Smoking and Substance Involvement Screening Test (ASSIST. V.3 French)

  5. General psychiatric symptoms [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 [0, 3, 6, 12 months]

    World Health Organization Disability Assessment Schedule (WHODAS)

  7. General life satisfaction: Satisfaction With Life Scale [0, 3, 6, 12 months]

    Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction)

  8. Advance directives written by the participant [at Baseline]

    Advance directives written by the participant (yes - no)

Other Outcome Measures

  1. Patient satisfaction with Assertive Community Treatment [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 [at 12 months]

    Daily contact log (Relevé quotidien des contacts (RQC)) in minutes spent with patient

  3. Type of Assertive Community Treatment intervention [at 12 months]

    Daily contact log (Relevé quotidien des contacts (RQC)): documentation of type of activity done with patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service d'addictologie, HUG Geneva Switzerland 1202

Sponsors and Collaborators

  • University Hospital, Geneva

Investigators

  • Principal Investigator: Louise Penzenstadler, MD, University Hospital, Geneva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Louise Penzenstadler, Principal investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT03623178
Other Study ID Numbers:
  • ID 2017-01087
First Posted:
Aug 9, 2018
Last Update Posted:
Aug 9, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Louise Penzenstadler, Principal investigator, University Hospital, Geneva
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2018