NCT05284370

Brief Summary

"In France and abroad, patient involvement is increasingly encouraged through the development of experiences involving patients in their care or that of their peers. The Association of PEs in Addictology (APEA) and the Addictology Department of the Bichat Hospital (APHP- Nord, University of Paris) have established a partnership in which PEs volunteer to work with patients throughout the course of their care. To date, no study has evaluated the impact of the PE program in addictology. A preliminary study within the department and the APEA is needed to evaluate the benefits to patients and caregivers, the feasibility and the cost in terms of staff time of implementing the PE program. The main objective of the project is to describe the care pathways of patients through their interactions with the PEs and the overall addiction care system, over a period of one year, within the Psychiatry-Addictology Department of the Bichat Hospital and then in the outpatient setting. The secondary objectives are to characterize and describe the patients' profiles according to these pathways; as well as to describe the contribution of EPs in the process of coordinating the care of these patients (interaction between patients - EPs - health professionals). This is a non-interventional monocentric cohort study in the Psychiatry-Addictology Department of the Bichat Hospital. In practice, data concerning interactions between patients and EPs and caregivers and EPs will be collected by EPs directly on an eCRF after each contact, for 12 months from inclusion. Patients will be followed during their care pathway for a total of one year, by two telephone assessments at 3 months and 6 months of hospital discharge. A final visit will be made 12 months after hospital discharge by face-to-face interview. Participation will end at the time of the debriefing interview, one year after inclusion. Modeling the interactions between patients and EPs, and between caregivers and EPs during a course of care in addictology, will lead to a better knowledge of the EP system and the place of EPs in the trajectories of addictology care. The effectiveness of the PE system can thus be recognized in the management of addictions, in complementarity with the caregivers. The driving factors for implementation will be identified in order to improve the dissemination of the PE system to other centers."

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 27, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 9, 2022

Last Update Submit

April 20, 2022

Conditions

Keywords

Expert patientAddictionsPatient engagementTreatmentCare pathway

Outcome Measures

Primary Outcomes (1)

  • Description of patients' care pathways through their interactions with EPs and the overall addiction care system, over a one-year period

    Description of patients' care pathways through their interactions with EPs and the overall addiction care system, over a one-year period

    Continuously for 1 year

Secondary Outcomes (26)

  • Characterize and describe patient profiles according to these pathways

    Inclusion, 3 months, 6 months and 12 months

  • Describe the contribution of EPs in terms of care coordination (interaction between patients - EPs - health professionals)

    During 1 year

  • Characterize and describe patient profiles according to these pathways

    Inclusion, 3 months, 6 months and 12 months

  • Characterize and describe patient profiles according to these pathways

    Inclusion, 3 months, 6 months and 12 months

  • Characterize and describe patient profiles according to these pathways

    Inclusion, 3 months, 6 months and 12 months

  • +21 more secondary outcomes

Eligibility Criteria

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

Patients hospitalized full-time for a substance-related disorder or addiction in the Psychiatry-Addictology Department of the Bichat Hospital, exposed for the first time to the patient-expert intervention, followed during one year of addictological care

You may qualify if:

  • Substance use disorder, diagnosed according to DSM-5 criteria, i.e. at least 2 diagnostic criteria
  • Patients without prior exposure to the PE device
  • Patients who received information about the research and did not object

You may not qualify if:

  • Non comprehension of French
  • Patient under guardianship or curatorship
  • Patient under AME
  • Patient's refusal".

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bichat Claude Bernard Hospital

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Behavior, AddictivePatient Participation

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Central Study Contacts

Delphine MOISAN, Médecin

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

March 17, 2022

Study Start

March 1, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 27, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations