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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03551301
Other study ID # ID 2017-00733
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date April 1, 2020

Study information

Verified date March 2024
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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. They often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis. They 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. Interventions in the field of addiction, such as Transitional Case Management (TCM) should increase the adherence of these patients to treatment by accompanying them in the sensitive period following hospitalization. One of the objectives of the study is to evaluate the impact of TCM on the number, duration and type of hospitalizations, as well as the number of emergency room visits. The investigators will also measure the duration until the possible future hospitalization, after the TCM. The secondary objectives of this study will be to see the effect of TCM on adherence to outpatient treatment. The investigators will focus on the impact of follow-up 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 by the TCM with the other users of the addiction service who are hospitalized. The study will investigate this through questionnaires at the beginning of care, at one month, three months, six months and 12 months after the start of TCM management.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 1, 2020
Est. primary completion date December 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Substance use disorder - Hospitalisation at recruitment - Substance Use Disorder according to the DSM-5 and one of the following criteria: - No preexisting outpatient follow-up care or regular follow-up care - More than three emergency room visits during the last 12 months - More than three hospitalizations in psychiatric hospital during the last 12 months - More than 40 hospitalization's days during the last 12 months - First hospitalization for a SUD Exclusion Criteria: - Evidence of organic brain disease or learning disability based on the chart review.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transitional Case Management
TCM program is a type of very flexible community treatment in terms of frequency and intensity of care. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialised in SUD treatment. The intervention begins during hospitalisation and lasts around 4 weeks after discharge from the hospital. The main aim of this intervention is to accompany the patient in the difficult phase of transition between hospital and outpatient care and ensure their adherence to the treatment program. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs. Another important aim is to reduce the number of (unplanned) hospitalizations and emergency room visits.

Locations

Country Name City State
Switzerland Service d'addictologie HUG Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient satisfaction with Transitional Case Management Patient satisfaction with Transitional Case Management at 1 month
Other Duration and intensity of Transitional Case Management intervention Daily contact log (Relevé quotidien des contacts (RQC)) at 1 month
Primary Hospital days Number of days in hospital at 12 months
Secondary Service use Number of hospital admissions at 12 months
Secondary Patient network Number of persons in network 0, 3, 6, 12 months
Secondary Time to first readmission to hospital Number of days to first readmission 0, 1, 3, 6, 12 months
Secondary Type of admission (planned versus unplanned) Type of admission (planned versus unplanned) reviewed on patient file 0, 1, 3, 6, 12 months
Secondary Number of ER visits Number of ER visits reviewed on patient file 0, 1, 3, 6, 12 months
Secondary Treatment adherence percentage of attended outpatient appointments reviewed on patient file 0, 1, 3, 6, 12 months
Secondary Number or Transitional Case Management interventions Number or Transitional Case Management interventions 0, 1, 3, 6, 12 months
Secondary Addictive behaviour Alcohol, Smoking and Substance Involvement Screening Test (ASSIST. V.3 French) 0, 1, 3, 6, 12 months
Secondary General psychiatric symptoms Health of Nation Outcome Scale - French version (HoNOS-F): scores 0 - 52 (higher score = more psychiatric symptoms) 0, 1, 3, 6, 12 months
Secondary Global functioning World Health Organization Disability Assessment Schedule (WHODAS) 0, 1, 3, 6, 12 months
Secondary General life satisfaction Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction) 0, 1, 3, 6, 12 months
Secondary Advance directives written by the participants Advance directives written by the participant (yes - no) at Baseline
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