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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090867
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
ICAN Nutrition Education and Research
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Critical Care Anxiety Depression Other: Relatives or surrogates are encouraged to perform care Other: Conventional ,care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Participation of Relative or Surrogate in the Patient's Care in Reanimation
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.





Primary Outcome Measures :
  1. Change from baseline HAD scale at ICU's discharge [ Time Frame: From baseline and at the patient's discharge from the ICU assessed up to 3 months ]

    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.



Secondary Outcome Measures :
  1. Evolution of the relative or surrogate anxiety/depression [ Time Frame: at baseline and after 10 days of ICU hospitalization. ]
    The relative or surrogate will complete the HAD scale and other anxiety/depression questionnaires.

  2. Evolution of the relative or surrogate anxiety/depression [ Time Frame: at baseline and at ICU's discharge assessed up to 3 months ]
    The relative or surrogate will complete the HAD scale questionnaires and anxiety/depression questionnaires.

  3. Evaluation of the satisfaction's relatives or surrogates regarding their participation in the ICU patient care by a questionnaire [ Time Frame: At the patient's ICU discharge assessed up to 3 months ]
    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

  4. Evaluation of the satisfaction of the ICU staff by a questionnaire [ Time Frame: Through study completion an average of 12 months ]

    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


  5. Quantify which care have been realized by the relatives or surrogates [ Time Frame: Through study completion an average of 12 months ]

    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


  6. HAD scale of the patient [ Time Frame: At the ICU discharge assessed up to 3 months ]
    The patient completes the HAD scale if his mental state allows it



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090867


Contacts
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Contact: Alain COMBES, M.D, Ph.D +33 1 42 16 38 18 alain.combes@aphp.fr
Contact: Chirine MOSSADEGH, Nurse +33 1 42 16 38 13 cmosssadegh@yahoo.fr

Locations
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France
Hôpital Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: COMBES Alain, MD       alain.combes@aphp.fr   
Contact: MOSSADEGH Chirine, Nurse       cmossadegh@yahoo.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ICAN Nutrition Education and Research
Investigators
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Principal Investigator: Alain COMBES, M.D, Ph.D Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03090867    
Other Study ID Numbers: P150301
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Clinical Practice Guideline
Critical care
Family-centered care
Professional-family relations
Family nursing
Anxiety
Depression
Participation in care
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms