- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02768584
Construction of the Therapeutic Alliance Between Inpatient Psychiatric Patients and Nurses (ATIASP)
Levers and Brakes to the Therapeutic Alliance Between Patients in Hospital Full-time Psychiatric and Nurses and Caregivers
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Paris, France, 75018
- EPS Maison Blanche
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic Alliance score overall with self-administered questionnaire STAR-P
Time Frame: day 0
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AT score overall, committed to using the self-administered questionnaire STAR-P particularly suitable for "patients with severe psychiatric disorders" (Rebecca, 2007).
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day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients reviewed in outpatient psychiatric consultation
Time Frame: three months after hospital discharge.
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three months after hospital discharge.
|
|
AT evaluated in patients using semi-structured interviews
Time Frame: day 0
|
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
|
AT evaluated in / nurse (s) and caregiver(s)
Time Frame: month 6
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AT evaluated in / nurse (s) and caregiver (s), through focus group: Research performances and determinants of therapeutic alliance with caregivers.
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month 6
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Determinants of AT studied
Time Frame: day 0
|
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
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day 0
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intermediate score STAR-P: score of positive collaboration
Time Frame: day 0
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day 0
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intermediate scores STAR-P: positive contribution score
Time Frame: day 0
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day 0
|
|
intermediate scores STAR-P: uncooperative intake score of the nursing team and caregiver
Time Frame: day 0
|
day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Manuel Morvillers, PhD, centre hospitalier Maison Blanche
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRIP 1300036N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
At the end of the study, patient could be informed of result of the study if they wish.
No individual result will be communicate.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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