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

Critical Illness Clinical Trial

— Intensiva2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03438175
• Other study ID #: 35410/2017
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2018
• Source: University of Milan
• Contact: Giovanni Mistraletti
• Phone: +39.339.8245014
• Email: giovanni.mistraletti[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: December 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

Intervention

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.

Locations

Country	Name	City	State
Italy	AO San Paolo - Polo Universitario	Milano

Sponsors (6)

Lead Sponsor	Collaborator
University of Milan	Ass. Anestesisti Rianimatori Ospedalieri Italiani – Em. Area Crit. (AAROI-EMAC), Associazione Nazionale Infermieri di Area Critica (ANIARTI), Catholic University of the Sacred Heart, Società Italiana di Anestesia Analgesia Rianimazione Terapia Intensiva (SIAARTI), Società Italiana di Anestesia, Rianimazione, Emergenza e Dolore (SIARED)

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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, Vince — View 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 — View 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 rega — View Citation

Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Günther 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correctness of comprehension	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)	7 days
Secondary	Anxiety	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)	7 days
Secondary	Depression	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)	7 days
Secondary	Acute traumatic stress	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)	7 days
Secondary	Post-traumatic stress disorder	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)	6 months
Secondary	Empathy	Evaluation of project effects on ICU staff involvement (Jefferson Scale for Physician Empathy, JSPE, minimum = 20, maximum = 140).	2 months
Secondary	Burnout	Evaluation of project effects on work satisfaction in ICU staff members (Maslach burnout inventory, MBI, minimum = 0, maximum = 132).	2 months