Home Treatment for Individuals Suffering From Severe Addictive Disorders
Primary Purpose
Substance Use Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hospital-like treatment in patients' home
standard inpatient treatment
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home treatment
Standard inpatient treatment
Arm Description
Home visits by care staff at the same frequency as in hospital
Inpatient treatment on hospital ward
Outcomes
Primary Outcome Measures
readmission rates
Number of readmissions to hospital during the 6 months following discharge
Secondary Outcome Measures
time to readmission
Number of days between discharge and readmission during the 6 months following discharge
length of hospitalization
total number of days spent in hospital during the 6 months following discharge
number of emergency room visits
number of emergency room visits during the 6 months following discharge
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.
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)
Full Information
NCT ID
NCT05563363
First Posted
September 23, 2022
Last Updated
September 28, 2022
Sponsor
Louise Penzenstadler
1. Study Identification
Unique Protocol Identification Number
NCT05563363
Brief Title
Home Treatment for Individuals Suffering From Severe Addictive Disorders
Official Title
A Pilot Study on Home Treatment for Individuals Suffering From Severe Addictive Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Louise Penzenstadler
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study, randomized, open, non-blinded
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home treatment
Arm Type
Experimental
Arm Description
Home visits by care staff at the same frequency as in hospital
Arm Title
Standard inpatient treatment
Arm Type
Active Comparator
Arm Description
Inpatient treatment on hospital ward
Intervention Type
Other
Intervention Name(s)
Hospital-like treatment in patients' home
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard inpatient treatment
Intervention Description
Inpatient treatment on addiction ward
Primary Outcome Measure Information:
Title
readmission rates
Description
Number of readmissions to hospital during the 6 months following discharge
Time Frame
6 month post-discharge
Secondary Outcome Measure Information:
Title
time to readmission
Description
Number of days between discharge and readmission during the 6 months following discharge
Time Frame
6 months
Title
length of hospitalization
Description
total number of days spent in hospital during the 6 months following discharge
Time Frame
6 months
Title
number of emergency room visits
Description
number of emergency room visits during the 6 months following discharge
Time Frame
6 months
Title
clinical outcome
Description
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.
Time Frame
6 months
Title
patient satisfaction
Description
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)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
12. IPD Sharing Statement
Learn more about this trial
Home Treatment for Individuals Suffering From Severe Addictive Disorders
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