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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02768584
Other study ID # PHRIP 1300036N
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 6, 2015
Est. completion date June 2018

Study information

Verified date July 2018
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clarify the determinants of the construction of a Therapeutic Alliance (AT) between paramedical staff (nurses and caregivers ) and adult patients in a functional unit of full-time general psychiatric Whether the quality of Therapeutic Alliance influences the continued support outpatient , after completion of full-time hospitalization.


Description:

This is a prospective, observational, multicenter inpatient units Parisian full time of the Etablissement Public Health White House (spread over 4 sites).

The study seeks to collect, on the one hand the level of AT obtained at the end of hospitalization in general adult psychiatry and, secondly, to understand how this one was built.

The AT will be measured:

- Firstly by the self-administered questionnaire STAR-P, translated into French by the "translation / back-translation" method.

- Secondly through semi-structured qualitative interviews, conducted at discharge by a health care setting or a specially trained and who did not participate directly in the patient's care included. Indeed, the questionnaires allow, through scales to measure the AT quantitative way through proposals (items) presented as so, and look for associations with some predefined decisive.

However, it is difficult to explore more complex combination of mechanisms. Conducting interviews can meet this goal. An interview grid will be conducted and organized around the search for representations and affects related relational patient / nurse(s) and caregiver(s) in the context of hospital care. The interviews will be recorded and fully transcribed. A thematic analysis will be conducted to identify the objects and themes. The inclusions in this qualitative analysis will stop when reaching the saturation process. In this type of study, it is generally necessary to include thirty people to reach saturation.

Finally, semi-structured group interviews (focus group) will be conducted by co-investigators and doctoral student psychologist caregivers with the discussion topic imposed: the AT construction. They will be directed to paramedics caregivers (nurses and caregivers) are not part of the investigation team conducting research but actively involved in care. Their goal will be to harvest their representations regarding the quality of the therapeutic relationship they're trying to build with patients. A focus group will be conducted by site (4 sites), with 5 to 12 volunteers per group.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date June 2018
Est. primary completion date January 11, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult patient (>18 years old)

- Adult psychiatric inpatients

Exclusion Criteria:

- Patients carrying perversion disorder or paranoia

- Patients trust whose legal representative refuses participation in the survey

- patients non covered by the french health system

- non consenting patients

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France EPS Maison Blanche Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic Alliance score overall with self-administered questionnaire STAR-P AT score overall, committed to using the self-administered questionnaire STAR-P particularly suitable for "patients with severe psychiatric disorders" (Rebecca, 2007). day 0
Secondary Number of patients reviewed in outpatient psychiatric consultation three months after hospital discharge.
Secondary AT evaluated in patients using semi-structured interviews AT evaluated in patients using semi-structured interviews (20-40 minutes), led with an interview grid: research of representations and affects related relational patient / nurse (s) and caregiver ( s) under hospital care. day 0
Secondary AT evaluated in / nurse (s) and caregiver(s) AT evaluated in / nurse (s) and caregiver (s), through focus group: Research performances and determinants of therapeutic alliance with caregivers. month 6
Secondary Determinants of AT studied socio-demographic characteristics (age, sex, socio-professional category (CSP), educational level, profession last exercised, wage level; Marital Status; Place of birth); primary psychiatric diagnosis (ICD-10); Companion diagnostics; Total number of psychiatric hospitalizations prior to the study; which stays in Difficult Patient Unit (UMD) in Free Care, in care without consent, or at the request of a representative of the state); Stay in therapeutic isolation room during hospitalization; Length of hospital stay; Supported by a referent nurse; Highlights in the treatment period and that could presuppose an impact on the quality of care day 0
Secondary intermediate score STAR-P: score of positive collaboration day 0
Secondary intermediate scores STAR-P: positive contribution score day 0
Secondary intermediate scores STAR-P: uncooperative intake score of the nursing team and caregiver day 0
See also
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