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

University of Milan

Status: Unknown

Conditions: Critical Illness; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute

Treatments: Behavioral: Enhanced communication by brochure, website and posters

Study type: Interventional

Funder types: Other

Identifiers

NCT03438175

35410/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,100 participants in 2 patient groups

Control

No Intervention group

Description:

Families of Critically Ill will be informed about patients'clinical status only by oral communication during daily family meeting

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced communication by brochure, website and posters