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

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety Depression; Critical Care
• Intervention / Treatment: Other: Conventional ,care; Other: Relatives or surrogates are encouraged to perform care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Hopital Pitie Salpetriere

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional arm; 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 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.
Experimental: The relative/surrogate will be encouraged to perform care; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the relative or surrogate anxiety/depression	The relative or surrogate will complete the HAD scale and other anxiety/depression questionnaires.	at baseline and after 10 days of ICU hospitalization.
Evolution of the relative or surrogate anxiety/depression	The relative or surrogate will complete the HAD scale questionnaires and anxiety/depression questionnaires.	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	Concern different aspects of the patient's management: listening skills and support from the ICU team, medical information about the patient, benefits and difficulties encountered while participating in care	At the patient's ICU discharge assessed up to 3 months
Evaluation of the satisfaction of the ICU staff by a questionnaire	Evaluate the feeling of the ICU staff regarding participation in care of surrogates and assess its evolution at the end of the study. The ICU staff can describe which benefits and difficuties they encountered while caring for the patient with the relative or surrogate. At initiation visit and at closing of the center	Through study completion an average of 12 months
Quantify which care have been realized by the relatives or surrogates	Each time a relative or surrogate is caring for the patient, the ICU staff will write it on a specific sheet. At the end of the study, all this data will be gathered to see which care have been done more often	Through study completion an average of 12 months
HAD scale of the patient	The patient completes the HAD scale if his mental state allows it	At the ICU discharge assessed up to 3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: ICAN Nutrition Education and Research
• Investigators: Principal Investigator: Alain COMBES, M.D, Ph.D, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): November 15, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Critical care; Clinical Practice Guideline; Family nursing; Family-centered care; Professional-family relations; Participation in care
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: P150301

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