NCT03551301

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

April 24, 2018

Last Update Submit

March 19, 2024

Conditions

Keywords

Substance Use DisordersCase ManagementCommunity TreatmentHospital discharge

Outcome Measures

Primary Outcomes (1)

  • Hospital days

    Number of days in hospital

    at 12 months

Secondary Outcomes (12)

  • Service use

    at 12 months

  • Patient network

    0, 3, 6, 12 months

  • Time to first readmission to hospital

    0, 1, 3, 6, 12 months

  • Type of admission (planned versus unplanned)

    0, 1, 3, 6, 12 months

  • Number of ER visits

    0, 1, 3, 6, 12 months

  • +7 more secondary outcomes

Other Outcomes (2)

  • Patient satisfaction with Transitional Case Management

    at 1 month

  • Duration and intensity of Transitional Case Management intervention

    at 1 month

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subgroup of high need users hospitalized in our addiction unit

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'addictologie HUG

Geneva, 1202, Switzerland

Location

Related Publications (1)

  • Chatton A, Khazaal Y, Penzenstadler L. A 13-item Health of the Nation Outcome Scale (HoNOS-13): validation by item response theory (IRT) in patients with substance use disorder. Addict Sci Clin Pract. 2023 Oct 24;18(1):64. doi: 10.1186/s13722-023-00416-8.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 24, 2018

First Posted

June 11, 2018

Study Start

September 1, 2017

Primary Completion

December 4, 2019

Study Completion

April 1, 2020

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations