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Intensiva 2.0: Improve the Communication Towards Families of Critically Ill Patients (Intensiva2)

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: NCT03438175
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborators:
Catholic University of the Sacred Heart
Società Italiana di Anestesia Analgesia Rianimazione Terapia Intensiva (SIAARTI)
Società Italiana di Anestesia, Rianimazione, Emergenza e Dolore (SIARED)
Ass. Anestesisti Rianimatori Ospedalieri Italiani – Em. Area Crit. (AAROI-EMAC)
Associazione Nazionale Infermieri di Area Critica (ANIARTI)
Information provided by (Responsible Party):
Giovanni Mistraletti, University of Milan

Brief Summary:
The admission of a loved one in an ICU is a hard experience for family members. They frequently feel fear and grief, develop anxiety and depression symptoms, or even show some behaviors as this event was a real traumatic one, like hyper-arousal, avoidance and intrusion in the daily life.To improve the communication between them and the ICU staff members, and to meet their needs in terms of medical comprehension and emotional legitimization, a specific website was built, and a brochure was printed to make them welcomed in the ICU; moreover, a series of poster was prepared for the family waiting room outside the ICU. These instruments appeared able to improve the correctness of prognosis comprehension and to decrease the post-traumatic stress symptoms in a multicenter study involving Italian ICUs. The proposal of the present study is to verify on a larger scale if these instruments can really ameliorate the empathic communication among staff members, without increase in workload, and to make less traumatic, for the family members, their experience during and after the ICU stay.

Condition or disease Intervention/treatment Phase
Critical Illness Stress Disorders, Traumatic, Acute Stress Disorders, Post-Traumatic Behavioral: Enhanced communication by brochure, website and posters Not Applicable

Detailed Description:

Many recent studies described the comprehension, the satisfaction, and the psychological consequences due to the experience of an ICU admission of a loved one. Even if satisfaction about meetings and clinical information is about 90%, from 50 to 70% of family members reported an incomplete medical comprehension, and 70% showed symptoms of anxiety and depression. Many interventions may considerably improve their ICU experience, regarding both the comprehension and the emotions. For example, the family members of ICU patients that receive clear and reassuring information can deal better with the stress associated with their loved one illness, or may participate in the clinical decisional processes with awareness and lighter emotional distress.

Literature shows that relationship with families of ICU patients presents these problems:

  1. comprehension of care essentials (diagnosis, prognosis about illness severity, interventions undertaken);
  2. trust on ICU staff members;
  3. management of their emotions (anxiety, fear, depression);
  4. post-traumatic stress symptoms due to the concerns about life-threatening diseases of their loved one.

To ameliorate the relationship and the communication in the harsh ICU environment, and to meet the problems aforementioned, in 2012 some instruments for families were created (website, brochure, posters). They present in non-technical language the activities and the environment of ICU, with the aim to increase their comprehension and - at the same time - to make them feel not alone and powerless.

To evaluate the effectiveness of these information instruments, a before-and-after study was done in 2012 in 12 Italian ICUs. These instruments were demonstrated able to improve the correctness of communication about outcome and treatment (not about the illness and the organ dysfunctions, that is responsibility of local staff), and to decrease the post-traumatic symptoms. Anxiety and depression symptoms were showed non-significantly decreased. The physicians also reported an improvement in the quality of communication with families. (Intensive Care Med. 2017 Jan;43(1):69-79). The main study limitations were: low prevalence of internet browsing among families; few participating centers; lacking of complete diagnosis of PTSD, made after 6 months from traumatic event; lacking of characteristics of staff members who participated on the family meetings. The present larger, randomized and controlled trial was then designed, to replicate and verify the preliminary results, overcoming the limits and finding new strategies of communication.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized, Multicenter, Before-after Study for a Large-scale Evaluation of the Effectiveness of a Multitasking Intervention to Improve the Communication Towards Families of Critically Ill Patients
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
No Intervention: Control
Families of Critically Ill will be informed about patients'clinical status only by oral communication during daily family meeting
Experimental: Intervention
Families of critically ill patients will receive during the first ICU day of their loved one a brochure presenting the ICU and inviting them to visit a website specifically created for this project: www.intensiva.it Moreover, in the waiting room of the ICU will be placed 8 posters to improve comprehension and to legitimize emotions.
Behavioral: Enhanced communication by brochure, website and posters
Several instruments to improve communication toward ICU patients' families were prepared for this study: a brochure of 12 pages, a website with 80 webpages, 8 posters for the waiting room, 1 sign for the ICU door. All these instruments are made to have more correct comprehension and to legitimize emotions of ICU patients' families.




Primary Outcome Measures :
  1. Correctness of comprehension [ Time Frame: 7 days ]
    Improvement in correctness of comprehension during the family meetings about medical information (main outcome: prognosis quo ad vitam), and about medical treatment and not diagnosis regarding organ dysfunction (comprehension assessment interview, CAI, minimum = 0, maximum = 16)


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: 7 days ]
    Evaluation of anxiety on families after an ICU admission of a loved one (Hospital Anxiety and Depression Scale, HADS, for anxiety: minimum = 0, maximum = 21)

  2. Depression [ Time Frame: 7 days ]
    Evaluation of depression on families after an ICU admission of a loved one (Hospital Anxiety and Depression Scale, HADS, for depression: minimum = 0, maximum = 21)

  3. Acute traumatic stress [ Time Frame: 7 days ]
    Evaluation of traumatic experience (ICU admission of a loved one) influence on families in the early term of the first ICU week (short screening scale for symptoms of post-traumatic stress disorder, minimum = 0, maximum = 7)

  4. Post-traumatic stress disorder [ Time Frame: 6 months ]
    Evaluation of traumatic experience (ICU admission of a loved one) influence on families in the long term of 6 months after ICU discharge (PTSD check list for DSM V - civilian version, PCL-5, minimum = 0, maximum = 80)

  5. Empathy [ Time Frame: 2 months ]
    Evaluation of project effects on ICU staff involvement (Jefferson Scale for Physician Empathy, JSPE, minimum = 20, maximum = 140).

  6. Burnout [ Time Frame: 2 months ]
    Evaluation of project effects on work satisfaction in ICU staff members (Maslach burnout inventory, MBI, minimum = 0, maximum = 132).



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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:

  • age ≥ 18 years
  • family member of ICU patient
  • patient with mechanical ventilation length expected at admission > 48 hours;

Exclusion Criteria:

  • refusal to participate;
  • inability to understand Italian language;
  • any previously diagnosed and not compensated psychiatric condition;
  • absence of visiting relatives in the first 4 ICU days.

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): NCT03438175


Contacts
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Contact: Giovanni Mistraletti +39.339.8245014 giovanni.mistraletti@unimi.it
Contact: Maria Grazia Bocci +39.340.9759951 mariagrazia.bocci@unicatt.it

Locations
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Italy
AO San Paolo - Polo Universitario Recruiting
Milano, Italy, 20142
Contact: Giovanni Mistraletti, MD    +39.339.8245014    giovanni.mistraletti@unimi.it   
Sponsors and Collaborators
University of Milan
Catholic University of the Sacred Heart
Società Italiana di Anestesia Analgesia Rianimazione Terapia Intensiva (SIAARTI)
Società Italiana di Anestesia, Rianimazione, Emergenza e Dolore (SIARED)
Ass. Anestesisti Rianimatori Ospedalieri Italiani – Em. Area Crit. (AAROI-EMAC)
Associazione Nazionale Infermieri di Area Critica (ANIARTI)
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giovanni Mistraletti, Confirmed University Researcher / Assistant Professor San Paolo University Hospital, Milan, University of Milan
ClinicalTrials.gov Identifier: NCT03438175    
Other Study ID Numbers: 35410/2017
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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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 Giovanni Mistraletti, University of Milan:
Post-traumatic Stress Disorder
Web-site
Communication
Intensive Care Unit
Comprehension
Additional relevant MeSH terms:
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Disease
Critical Illness
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic, Acute
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Disease Attributes