Clinical trial NCT03090867: Participation of Relative or Surrogate in the Patient's Care in Reanimation
Official title: Participation of Relative or Surrogate in the Patient's Care in Reanimation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Care
Anxiety Depression
Keywords: Clinical Practice Guideline
Critical care
Family-centered care
Professional-family relations
Family nursing
Anxiety
Depression
Participation in care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ICAN Nutrition Education and Research
First posted: 2017-03-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Randomisation visit - D1:

After checking the eligibilities criteria, a member of the staff will explain to the patient and his relative or surrogate the purpose and the planning of the study. The inform consent will be signed by the physician of the study. Two informs consents will be signed : one by the patient and the other one by the relative or surrogate. The randomisation will be done after collecting these consents.

After the draw, the subjects will be randomized either in the control group "Conventional support" or the experimental group "Intervention".

Questionnaires to be completed by the :

* relatives or surrogates: Hospital Anxiety and Depression scale (HAD scale), Multidimensional Fatigue Inventory (MFI20), Zarit Burden Interview (ZARIT sale) , Beck Depression Inventory (Beck), State-Trait Anxiety Scale (STAI) and "preliminary"
* patient if possible: HAD scale

Admission + 10 days visit:

Questionnaires to be completed by the relatives or surrogates: HAD scale, MIF20, ZARIT, Beck, STAI and "discharge"

ICU discharge visit :

Questionnaires to be completed by the :

* relatives or surrogates: HAD scale, MIF20, ZARIT, Beck, STAI and "discharge"
* patient if possible: HAD scale

Medical staff:

In order to evaluate the feeling of the ICU staff, a satisfaction questionnaire will be propose at the beginning and at the end of the study.

Eligibility criteria: Inclusion criteria

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

Exclusion criteria

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

Primary outcomes:
measure: Change from baseline HAD scale at ICU's discharge
timeFrame: From baseline and at the patient's discharge from the ICU assessed up to 3 months
Secondary outcomes:
measure: Evolution of the relative or surrogate anxiety/depression
timeFrame: at baseline and after 10 days of ICU hospitalization.
measure: Evolution of the relative or surrogate anxiety/depression
timeFrame: at baseline and at ICU's discharge assessed up to 3 months
measure: Evaluation of the satisfaction's relatives or surrogates regarding their participation in the ICU patient care by a questionnaire
timeFrame: At the patient's ICU discharge assessed up to 3 months
measure: Evaluation of the satisfaction of the ICU staff by a questionnaire
timeFrame: Through study completion an average of 12 months
measure: Quantify which care have been realized by the relatives or surrogates
timeFrame: Through study completion an average of 12 months
measure: HAD scale of the patient
timeFrame: At the ICU discharge assessed up to 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alain COMBES, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.