Participation of Relative or Surrogate in the Patient's Care in Reanimation

NCT03090867 | Unknown

• 1 other identifier: P150301
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

ICUs have always perceived by the public has a very technical unit with a restricted and/or forbidden access. Physical alteration of the patient, seeing the patient sedated, the large numbers of devices, the alarms and an uncertain prognosis. All this factors can be perceived by people close to the patient as a source of stress. In the literature, numerous studies have shown that families develop anxiety and depression symptoms while their loved one is hospitalized in the ICU. French intensive care societies thought of ways to prevent or diminish these symptoms. The 6th consensus conference on " Live better in the ICU " recommends: effective and adapted information, large visiting hours to reach an unrestricted access and family participation in care. The unit has taken this path to improve patient and family centered care by: creating a welcome leaflet, a room dedicated to meetings with families and an ICU open 24/7bto families, with the possibility for children to visit their parents. Hence, spontaneously, relatives have expressed the wish to participate to certain care and when participating, expressed their satisfaction. This observation and testimonies from family members and patients led us to think about the impact of participation of care. Two major French studies have shown contradictory outcomes: 16% of families would have been willing to participate in the first study against 97% in the second one. These studies were survey done after the ICU discharge. No study today has assessed the actual impact of family participation in care. The aim of this clinical trial is to diminish anxiety and depression symptoms. By participating in care, relatives can develop or strengthen a relationship of trust with caregivers. It could contribute also to a better understanding of the plan of care and an easier context to announce negative outcomes.

Conditions

Critical Care; Anxiety Depression

Keywords

Clinical Practice Guideline; Critical care; Family-centered care; Professional-family relations; Family nursing; Anxiety; Depression; Participation in care

Outcome Measures

Primary Outcomes (1)

• Change from baseline HAD scale at ICU's discharge

  HAD Scale : The primary outcome measure is the relative or surrogate HAD (Hospital Anxiety and Depression Scale) score evolution. The expected result is a reduction by two points of the total HAD score through active participation in care.

  From baseline and at the patient's discharge from the ICU assessed up to 3 months

Secondary Outcomes (6)

• Evolution of the relative or surrogate anxiety/depression

  at baseline and after 10 days of ICU hospitalization.

• Evolution of the relative or surrogate anxiety/depression

  at baseline and at ICU's discharge assessed up to 3 months

• Evaluation of the satisfaction's relatives or surrogates regarding their participation in the ICU patient care by a questionnaire

  At the patient's ICU discharge assessed up to 3 months

• Evaluation of the satisfaction of the ICU staff by a questionnaire

  Through study completion an average of 12 months

• Quantify which care have been realized by the relatives or surrogates

  Through study completion an average of 12 months

Study Arms (2)

Conventional arm

ACTIVE COMPARATOR

The relative or surrogate will not be encouraged to perform care. The management of the relative or surrogate wi ll not changed from the regular standard of the ICU.

Other: Conventional ,care

The relative/surrogate will be encouraged to perform care

EXPERIMENTAL

The relative or surrogate will perform at least two cares a week . A manual will be given to the relative or surrogate, explaining the different care he can choose to perform on the patient. The care proposed are: feeding, mouth care, hair wash, shaving, eye care, hand, foot and face massage. All care are planned and perform under the supervision or/and in collaboration with a caregiver. Each care is written down on a collecting sheet.

Other: Relatives or surrogates are encouraged to perform care

Interventions

Relatives or surrogates are encouraged to perform care OTHER

The relative or surrogate will perform at least two cares a week among feeding, mouth care, hair wash, shaving, eye care, hand, foot and face massage. All care are planned and perform under the supervision or/and in collaboration with a caregiver. The relative or surrogate will give his opinion by completing the study questionnaires.

The relative/surrogate will be encouraged to perform care

Conventional ,care OTHER

The relative or surrogate will not be encouraged to perform care. The management of the relative or surrogate wi ll not changed from the regular standard of the ICU.

Conventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An adult related to the ICU patients, giving his written consent to participate to the study
• Being present at the patient's bedside at least twice a week
• Speaking and writing comprehension of the french language
• Adult ICU patient, admitted in the ICU for less than 72 hours, whatever its pathology
• Predictable ICU stay over a week

You may not qualify if:

• Refusal of the relative or surrogate
• Refusal of the patient
• The relative or surrogate can't be present at the patient's bedside at least twice a week
• Relative or surrogate already participating in the care of the patient for a chronic disease

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ICAN Nutrition Education and Research: collaborator

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (2)

• Azoulay E, Pochard F, Chevret S, Arich C, Brivet F, Brun F, Charles PE, Desmettre T, Dubois D, Galliot R, Garrouste-Orgeas M, Goldgran-Toledano D, Herbecq P, Joly LM, Jourdain M, Kaidomar M, Lepape A, Letellier N, Marie O, Page B, Parrot A, Rodie-Talbere PA, Sermet A, Tenaillon A, Thuong M, Tulasne P, Le Gall JR, Schlemmer B; French Famirea Group. Family participation in care to the critically ill: opinions of families and staff. Intensive Care Med. 2003 Sep;29(9):1498-504. doi: 10.1007/s00134-003-1904-y. Epub 2003 Jul 10.

  PMID: 12856124 BACKGROUND

• Garrouste-Orgeas M, Willems V, Timsit JF, Diaw F, Brochon S, Vesin A, Philippart F, Tabah A, Coquet I, Bruel C, Moulard ML, Carlet J, Misset B. Opinions of families, staff, and patients about family participation in care in intensive care units. J Crit Care. 2010 Dec;25(4):634-40. doi: 10.1016/j.jcrc.2010.03.001.

  PMID: 20435430 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Alain COMBES, M.D, Ph.D

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: March 27, 2017
• Study Start: November 16, 2017
• Primary Completion: November 15, 2019
• Study Completion: February 1, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)