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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04818684
Other study ID # CHUBX 2019/60
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date May 15, 2022

Study information

Verified date January 2024
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The PROPAGE study program aims above all to improve the experience and satisfaction of family and friends regarding the support they receive during the dying person's agony phase.


Description:

The objective of PROPAGE 2 is to establish a consensus on the practices for accompanying relatives during the agonic phase in the context of hospitalization in the palliative care unit by an interdisciplinary team.


Recruitment information / eligibility

Status Completed
Enrollment 278
Est. completion date May 15, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility INCLUSION CRITERIA 1. PALLIATIVE CARE UNITS (USP) 35 palliative care unit will be drawn at random among the 164 French palliative care unit (www.sfap.org). In the event of refusal of participation, the drawing of lots will continue until 35 participating palliative care unit are obtained. The inclusion criteria for palliative care units were determined from the survey carried out in 2013 by the National End of Life Observatory on palliative care units in France. In order for there to be representativeness, the status of the palliative care unit will be taken into account from the national University Hospital (CHU) distribution, excluding CHU in the public sector, private non-profit sector, private for-profit sector. Thus, out of the 35 palliative care units: 7 will be within CHU, 16 will be outside CHU in the public sector, 7 will be in the private non-profit sector, and 5 in the private for-profit sector (criteria determined from the survey of the National End of Life Observatory in 2013) by ensuring that there are no more than 3 palliative care units in the same department (this in order to avoid that a geographical territory is over-represented, which would be liable to bias the results). In the event of refusal of a palliative care units or of inadequacy of the criteria, the drawing of lots will be continued until 35 participating USPs are obtained. Each team of these palliative care units must allow the participation of 7 experts: 1 for each group of experts, i.e. 5 socio-health professionals working in all the palliative care units (doctors, psychologists, nursing assistants, nurses, socio-educational assistant) as well as the coordinator of support volunteers and a relative by palliative care unit. 2. THE EXPERTS 6 volunteer experts who will participate in the panel of voters: a doctor (group 1), an IDE ( group 2), an AS (group 3), a psychologist (group 4), an ASE (group 5), a volunteer support coordinator (group 6) . A relative (group 7) will be done. The inclusion criteria: - For professionals, at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. - For volunteers, at least 3 years of seniority in palliative care unit will be required, including 1 year in the participating palliative care unit. The representative participating in the study will preferably be the volunteer coordinator. - For relatives Relative of a patient who died in the palliative care unit at least 6 months ago Person to trust or to prevent if not designated Relative understanding and speaking sufficient French Relative not a health professional Relative who visited the palliative care unit during the last 3 days of the patient's life and who met the care team: - Traceability of the arrival of the loved one in the last 2/3 days of the patient's hospitalization - Traceability of a meeting of the loved one with a member of the team over the last 3 days of his hospitalization or verification during telephone contact with the loved one after drawing lots Relative with an email address (to be verified during telephone contact with the loved one after drawing lots) NO-INCLUSION AND EXCLUSION CRITERIA 1. PALLIATIVE CARE UNITS Palliative care unit who could not be represented by the 7 experts required - Have participated in the PROPAGE 1 study - Have taken part in the questionnaire test. 2. THE EXPERTS Palliative care unit Experts: Anyone with less than 3 years of palliative care unit experience. Relatives: Relative of a patient who died in the palliative care unit less than 6 months ago Relative not understanding and not speaking French enough Relative being a health professional Relative who has not been to the palliative care unit in the last 3 days of the patient's life Relative who does not have an email address (to be checked during telephone contact with the loved one after drawing lots).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
a questionnaire consisting of a list of support practices

Locations

Country Name City State
France Chu de Nimes Nîmes

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree). It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments. Day 1
Primary Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree). It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments. Month 2
Primary Score of Likert-type scales (rated between 0 and 9), best match what each participant think about support practices for relatives of persons in the agony phase : from 1 (strongly disagree) to 9 (strongly agree). It is based on a questionnaire made up of a list of support practices developed from the literature review and the list of practices identified through focus groups in the preliminary study PROPAGE 1. The responses are collected. on Likert-type scales reflecting the degree of agreement towards a proposition (rated between 0 and 9) and / or in the form of free comments. Month 4
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