Home Treatment for Individuals Suffering From Severe Addictive Disorders

A Pilot Study on Home Treatment for Individuals Suffering From Severe Addictive Disorders

Home Treatment (HT) has been successfully implemented in adult psychiatry in several countries including Switzerland. Patients with addiction problems were generally excluded even if the latter was not the main diagnosis. On the other hand, community treatments have successfully been established for these individuals. The investigators have recently offered HT to persons with severe addictive disorders which was well accepted.

The investigators intend to conduct a pilot study to prepare a large-scale study if successful. The investigators intend to compare HT to treatment as usual (regular inpatient treatment) on a specialized ward with respect to readmission rates during 6 months after discharge. The data show that 70.8% of all readmissions occur during the first 6 months. Therefore, a period of 6 months is considered an adequate time interval to sufficiently answer this pilot study's question.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorders
• Intervention / Treatment: Other: Hospital-like treatment in patients' home; Other: standard inpatient treatment

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louise Penzenstadler, MD; Phone Number: +41223725750; Email: Louise.E.Penzenstadler@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Recruiting
    • Geneva University Hospital
    • Contact: Louise Penzenstadler, MD; Phone Number: +41223725750; Email: Louise.E.Penzenstadler@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Substance use disorder
• age 18 or above
• sufficient french language skills
• competent subjects
• consent to randomization progress

Exclusion Criteria:

• organic brain disease or developmental disorder
• non voluntary admission
• severe somatic comorbidity
• History of complicated substance withdrawal
• acute suicidal ideation
• aggressive behavior
• acute psychiatric disease such as mania or psychosis
• distance to center (must be reachable within 60 minutes)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home treatment; Home visits by care staff at the same frequency as in hospital	Other: Hospital-like treatment in patients' home; Hospital-like treatment in patients' home. Caregivers, medical doctors and social workers will make several visits per day to the patients' home. 24/7 contact is available.
Active Comparator: Standard inpatient treatment; Inpatient treatment on hospital ward	Other: standard inpatient treatment; Inpatient treatment on addiction ward

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
readmission rates	Number of readmissions to hospital during the 6 months following discharge	6 month post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to readmission	Number of days between discharge and readmission during the 6 months following discharge	6 months
length of hospitalization	total number of days spent in hospital during the 6 months following discharge	6 months
number of emergency room visits	number of emergency room visits during the 6 months following discharge	6 months
clinical outcome	clinical outcomes measured with Health of the Nation Outcome scale (HoNOS) scoring 0 (no symptoms) to 48 (high symptom level) and the Brief Symptom Check-List (short form of the Brief Symptom Inventory), scoring 0-53 items (higher score = more symptoms). Measured at the start and end of intervention/hospital treatment.	6 months
patient satisfaction	Patient satisfaction measured with the S-ANQ (https://www.anq.ch/en/), a questionnaire used by all Swiss hospitals to measure patient satisfaction with treatment. The questionnaire includes 6 questions which are marked from 0 not at all satisfied to 5 = very satisfied. Scoring 0 (not at all satisfied) to 30 (very satisfied)	6 months

Collaborators and Investigators

• Sponsor: Louise Penzenstadler

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: not yet available (not yet available)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No