Home Treatment for Individuals Suffering From Severe Addictive Disorders

Sponsor
Louise Penzenstadler (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05563363
Collaborator
(none)
40
2
19

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hospital-like treatment in patients' home
  • Other: standard inpatient treatment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pilot study, randomized, open, non-blindedPilot study, randomized, open, non-blinded
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Study on Home Treatment for Individuals Suffering From Severe Addictive Disorders
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. readmission rates [6 month post-discharge]

    Number of readmissions to hospital during the 6 months following discharge

Secondary Outcome Measures

  1. time to readmission [6 months]

    Number of days between discharge and readmission during the 6 months following discharge

  2. length of hospitalization [6 months]

    total number of days spent in hospital during the 6 months following discharge

  3. number of emergency room visits [6 months]

    number of emergency room visits during the 6 months following discharge

  4. clinical outcome [6 months]

    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.

  5. patient satisfaction [6 months]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Louise Penzenstadler

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Louise Penzenstadler, Dr, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT05563363
Other Study ID Numbers:
  • not yet available
First Posted:
Oct 3, 2022
Last Update Posted:
Oct 3, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2022