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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Critical Care; Anxiety Depression

Treatments: Other: Conventional ,care; Other: Relatives or surrogates are encouraged to perform care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03090867

P150301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Conventional arm

Active Comparator group

Description:

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.

Treatment:

Other: Conventional ,care

The relative/surrogate will be encouraged to perform care

Experimental group

Description:

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.

Treatment:

Other: Relatives or surrogates are encouraged to perform care