Critical Care Clinical Trial
— PARTICIPATEOfficial title:
Participation of Relative or Surrogate in the Patient's Care in Reanimation
Verified date | January 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 140 |
Est. completion date | February 2020 |
Est. primary completion date | November 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | ICAN Nutrition Education and Research |
France,
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. Epub 2003 Jul 10. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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