Use of Antipsychotics in Palliative Care (NEUROPAL) (NEUROPAL)

Of the Use of Antipsychotics in Palliative Care : Prospective, Multicenter, Observational Study.

There are not lots of recommendations for the use of antipsychotics in palliative care. The National Agency for Accreditation and Evaluation in Health (ANAES) and the French Society for Accompaniment and Palliative Care, in 2002, make it the first-line treatment for confusion in palliative care, but there are no information on the molecules to be used, the dosage or the route of administration.

Many symptoms can motivate the prescription of an antipsychotic and many molecules exist. Their mode of action is substantially the same but their pharmacological properties sometimes give them different beneficial effects or side effects. They are studied in psychiatry but very little in palliative care.

Depending on the symptom (s) presented by the patient, either of these antipsychotics may be preferred. Use appear to differ from one center to another.

The investigator propose a multicenter, prospective, observational study describing the antipsychotics used according to the symptom.

This study should include 100 patients over the age of 18 years in palliative care (regardless of pathology) who are not taking antipsychotics and for whom the decision to introduce an antipsychotic is made regardless of the symptom.

The purpose of this work is to describe the most commonly used antipsychotic according to a particular symptom, as well as the dosage and route of administration.

The investigator will also evaluate the 7-day efficacy of the chosen antipsychotic on the symptom that motivated the prescription, and we will compare the dosages of the associated treatments before and after the introduction of this new treatment.

Study Overview

• Status: Unknown
• Conditions: Antipsychotics in Palliative Care

Detailed Description

The investigator will question the practice of palliative care physicians in several centers regarding the use of antipsychotics.

When a patient meeting the inclusion criteria has been identified by an investigating physician. The participant fills out a questionnaire containing some general information about the investigating physician and the patient, followed by a first questionnaire, called A Form (to be completed on D0, when the antipsychotic is introduced) with 8 questions on the prescribing symptom, antipsychotic used and associated therapies.

Seven days later, the same physician will fill out a second form, called B Form (to be completed on D7), with 9 questions on treatment efficacy, possible modifications and associated treatments.

Each investigating physician includes a maximum of 4 patients over the 6-month inclusion period.

Once the 4 questionnaires have been completed (Form A and Form B), he / she returns it to the principal investigator of the study, by e-mail to etudeneuropal@gmail.com, or by mail: Dr Marie LEPOUPET, Mobile Pain-Palliative Care Unit CHU, Côte de Nacre Avenue, 14,000 CAEN.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in palliative care, regardless of the stage of their progressive, life-threatening disease (as defined by ANAES and SFAP)

Description

Inclusion Criteria:

• all patients over the age of 18 years in palliative care, regardless of the stage of their illness, and according to the definition used by ANAES and SFAP (all patients suffering from a serious, progressive disease involving life-threatening, advanced or terminal).
• having a social security cover
• not taking antipsychotics at the time of inclusion, nor within 3 days before inclusion.
• for whom the doctor, investigator, decides to prescribe an antipsychotic, whatever it is, whatever the symptom motivating this prescription, whatever the dosage and the route of administration used.

Drugs related to antipsychotics, such as metoclopramide, metopimazine, alizapride or domperidone, are not included in this study.

Exclusion Criteria:

• patients with contraindications to antipsychotics
• patients already taking an antipsychotic, or for whom an antipsychotic was stopped less than 3 days ago.
• patients under 18 years of age.
• pregnant women
• patients protected by the law
• patients who are unable to refrain from participating in a study, and for whom the entourage (a trusted person, relatives, etc.) is also unable to refrain from such participation.

The study can be released at any time at the request of the patient and / or his entourage.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antipsychotic name (ICD)	name (ICD) of the antipsychotic used according to the symptom presented by the patient	when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion
administration route	Per os, Subcutaneous, Intravenous, Sublingual, Intramuscular	when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion
daily dosage	milligrams per day	when the antipsychotic is first prescribed by the investigator and so the patient included in the study, up to 6 months between the beginning of the study and the patient inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
simple verbal scale of efficiency of the antipsychotic on the symptom	simple verbal scale : weak, medium, strong, very strong	evaluation by the patient or the investigator if patient impossible, 7 days after the introduction of the antipsychotic.
change of dosage of the associated treatments		comparison between the dosage of each associated treatment at Day 0 and Day 7

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Study Director: Christophe KASSEL, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): May 1, 2018

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (ACTUAL): May 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: palliative care; antipsychotic
• Other Study ID Numbers: 16-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No