Transitional Case Management for Patients Suffering From Substance Use Disorders

March 19, 2024 updated by: Louise Penzenstadler, University Hospital, Geneva
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1202
        • Service d'addictologie HUG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subgroup of high need users hospitalized in our addiction unit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital days
Time Frame: at 12 months
Number of days in hospital
at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Service use
Time Frame: at 12 months
Number of hospital admissions
at 12 months
Patient network
Time Frame: 0, 3, 6, 12 months
Number of persons in network
0, 3, 6, 12 months
Time to first readmission to hospital
Time Frame: 0, 1, 3, 6, 12 months
Number of days to first readmission
0, 1, 3, 6, 12 months
Type of admission (planned versus unplanned)
Time Frame: 0, 1, 3, 6, 12 months
Type of admission (planned versus unplanned) reviewed on patient file
0, 1, 3, 6, 12 months
Number of ER visits
Time Frame: 0, 1, 3, 6, 12 months
Number of ER visits reviewed on patient file
0, 1, 3, 6, 12 months
Treatment adherence
Time Frame: 0, 1, 3, 6, 12 months
percentage of attended outpatient appointments reviewed on patient file
0, 1, 3, 6, 12 months
Number or Transitional Case Management interventions
Time Frame: 0, 1, 3, 6, 12 months
Number or Transitional Case Management interventions
0, 1, 3, 6, 12 months
Addictive behaviour
Time Frame: 0, 1, 3, 6, 12 months
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST. V.3 French)
0, 1, 3, 6, 12 months
General psychiatric symptoms
Time Frame: 0, 1, 3, 6, 12 months
Health of Nation Outcome Scale - French version (HoNOS-F): scores 0 - 52 (higher score = more psychiatric symptoms)
0, 1, 3, 6, 12 months
Global functioning
Time Frame: 0, 1, 3, 6, 12 months
World Health Organization Disability Assessment Schedule (WHODAS)
0, 1, 3, 6, 12 months
General life satisfaction
Time Frame: 0, 1, 3, 6, 12 months
Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction)
0, 1, 3, 6, 12 months
Advance directives written by the participants
Time Frame: at Baseline
Advance directives written by the participant (yes - no)
at Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction with Transitional Case Management
Time Frame: at 1 month
Patient satisfaction with Transitional Case Management
at 1 month
Duration and intensity of Transitional Case Management intervention
Time Frame: at 1 month
Daily contact log (Relevé quotidien des contacts (RQC))
at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID 2017-00733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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