NCT02491866

Brief Summary

Objectives

  1. 1.to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry.
  2. 2.to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.

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
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

June 24, 2015

Last Update Submit

August 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of care

    computerized Adaptative Testing

    19 months

Study Arms (1)

psychiatric patients

OTHER

patients with schizophrenia, bipolar disorder or depression according DSM V criteria

Other: to develop and validate a Computerized Adaptative Testing

Interventions

* Elaboration of a pool of items, based on literature review and interview with patients. * Selection of the most relevant items based on a qualitative approach using cognitive interview with patients. * Calibration of the item bank : the psychometric properties of the item bank will be based on classical test and item response theories and approaches, including the evaluation of unidimensionality, item response theory model fitting, and analyses of differential item functioning. * Metrological validation of the CAT. * Analysis of the implementation of the CAT in clinical practice using interview with professionals and patients.

psychiatric patients

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of schizophrenia, bipolar disorder or depression according DSM V
  • criteria
  • age over 18 years
  • informed consent to participate
  • French as the native language

You may not qualify if:

  • diagnosis other than schizophrenia, bipolar disorder or depression according DSM V criteria
  • decompensated organic disease, and mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de la conception Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

Related Publications (5)

  • Fernandes S, Brousse Y, Zendjidjian X, Cano D, Riedberger J, Llorca PM, Samalin L, Dassa D, Trichard C, Laprevote V, Sauvaget A, Abbar M, Misdrahi D, Berna F, Lancon C, Coulon N, El-Hage W, Rozier PE, Benoit M, Giordana B, Caqueo-Urizar A, Yon DK, Tran B, Auquier P, Fond G, Boyer L. Psychometric Assessment of an Item Bank for Adaptive Testing on Patient-Reported Experience of Care Environment for Severe Mental Illness: Validation Study. JMIR Ment Health. 2024 May 16;11:e49916. doi: 10.2196/49916.

  • Boyer L, Fernandes S, Brousse Y, Zendjidjian X, Cano D, Riedberger J, Llorca PM, Samalin L, Dassa D, Trichard C, Laprevote V, Sauvaget A, Abbar M, Misdrahi D, Berna F, Lancon C, Coulon N, El-Hage W, Rozier PE, Benoit M, Giordana B, Caqueo-Urizar A, Yon DK, Tran B, Auquier P, Fond G. Development of the PREMIUM computerized adaptive testing for measuring the access and care coordination for patients with severe mental illness. Psychiatry Res. 2023 Oct;328:115444. doi: 10.1016/j.psychres.2023.115444. Epub 2023 Sep 1.

  • Fernandes S, Fond G, Zendjidjian X, Michel P, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Misdrahi D, Llorca PM, Coldefy M, Auquier P, Baumstarck K, Boyer L. A conceptual framework to develop a patient-reported experience measure of the quality of mental health care: a qualitative study of the PREMIUM project in France. J Mark Access Health Policy. 2021 Feb 23;9(1):1885789. doi: 10.1080/20016689.2021.1885789.

  • Fernandes S, Fond G, Zendjidjian XY, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L; French PREMIUM Group. Measuring the Patient Experience of Mental Health Care: A Systematic and Critical Review of Patient-Reported Experience Measures. Patient Prefer Adherence. 2020 Nov 3;14:2147-2161. doi: 10.2147/PPA.S255264. eCollection 2020.

  • Fernandes S, Fond G, Zendjidjian X, Michel P, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L. The Patient-Reported Experience Measure for Improving qUality of care in Mental health (PREMIUM) project in France: study protocol for the development and implementation strategy. Patient Prefer Adherence. 2019 Jan 21;13:165-177. doi: 10.2147/PPA.S172100. eCollection 2019.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 8, 2015

Study Start

May 27, 2015

Primary Completion

August 1, 2017

Study Completion

October 1, 2018

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations