Clinical trial NCT03438175: Intensiva 2.0: Improve the Communication Towards Families of Critically Ill Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Stress Disorders, Traumatic, Acute
Stress Disorders, Post-Traumatic
Keywords: Post-traumatic Stress Disorder
Web-site
Communication
Intensive Care Unit
Comprehension
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
name: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
name: Società Italiana di Anestesia, Rianimazione, Emergenza e Dolore (SIARED)
name: Ass. Anestesisti Rianimatori Ospedalieri Italiani - Em. Area Crit. (AAROI-EMAC)
name: Associazione Nazionale Infermieri di Area Critica (ANIARTI)
First posted: 2018-02-19
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Correctness of comprehension
timeFrame: 7 days
Secondary outcomes:
measure: Anxiety
timeFrame: 7 days
measure: Depression
timeFrame: 7 days
measure: Acute traumatic stress
timeFrame: 7 days
measure: Post-traumatic stress disorder
timeFrame: 6 months
measure: Empathy
timeFrame: 2 months
measure: Burnout
timeFrame: 2 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: AO San Paolo - Polo Universitario
Study officials:
References:
citation: Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.
citation: Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med. 2001 Oct;29(10):1893-7. doi: 10.1097/00003246-200110000-00007.
citation: Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.
citation: Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Gunther A, Witte OW, Reinhart K, Hartog CS. Family satisfaction in the intensive care unit: a quantitative and qualitative analysis. Intensive Care Med. 2013 Jun;39(6):1071-9. doi: 10.1007/s00134-013-2862-7. Epub 2013 Feb 16.
citation: Mistraletti G, Umbrello M, Mantovani ES, Moroni B, Formenti P, Spanu P, Anania S, Andrighi E, Di Carlo A, Martinetti F, Vecchi I, Palo A, Pinna C, Russo R, Francesconi S, Valdambrini F, Ferretti E, Radeschi G, Bosco E, Malacarne P, Iapichino G; http://www.intensiva.it Investigators. A family information brochure and dedicated website to improve the ICU experience for patients' relatives: an Italian multicenter before-and-after study. Intensive Care Med. 2017 Jan;43(1):69-79. doi: 10.1007/s00134-016-4592-0. Epub 2016 Nov 9.
citation: Mistraletti G, Mezzetti A, Anania S, Ionescu Maddalena A, Del Negro S, Giusti GD, Gili A, Iacobone E, Pulitano SM, Conti G, Bocci MG. Improving communication toward ICU families to facilitate understanding and reduce stress. Protocol for a multicenter randomized and controlled Italian study. Contemp Clin Trials. 2019 Nov;86:105847. doi: 10.1016/j.cct.2019.105847. Epub 2019 Sep 13.