Intensiva 2.0: Improve the Communication Towards Families of Critically Ill Patients (Intensiva2)
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|ClinicalTrials.gov Identifier: NCT03438175|
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : May 22, 2018
|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|
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:
- comprehension of care essentials (diagnosis, prognosis about illness severity, interventions undertaken);
- trust on ICU staff members;
- management of their emotions (anxiety, fear, depression);
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2100 participants|
|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|
No Intervention: Control
Families of Critically Ill will be informed about patients'clinical status only by oral communication during daily family meeting
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.
- 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)
- 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)
- 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)
- 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)
- 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)
- Empathy [ Time Frame: 2 months ]Evaluation of project effects on ICU staff involvement (Jefferson Scale for Physician Empathy, JSPE, minimum = 20, maximum = 140).
- Burnout [ Time Frame: 2 months ]Evaluation of project effects on work satisfaction in ICU staff members (Maslach burnout inventory, MBI, minimum = 0, maximum = 132).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438175
|Contact: Giovanni Mistralettifirstname.lastname@example.org|
|Contact: Maria Grazia Bocciemail@example.com|
|AO San Paolo - Polo Universitario||Recruiting|
|Milano, Italy, 20142|
|Contact: Giovanni Mistraletti, MD +39.339.8245014 firstname.lastname@example.org|