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

NCT03438175 | Unknown DMC

• 1 other identifier: 35410/2017
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Post-traumatic Stress Disorder; Web-site; Communication; Intensive Care Unit; Comprehension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Anxiety

  7 days

• Depression

  7 days

• Acute traumatic stress

  7 days

• Post-traumatic stress disorder

  6 months

• Empathy

  2 months

Study Arms (2)

Control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Interventions

Enhanced communication by brochure, website and posters BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milan: lead
• Catholic University of the Sacred Heart: collaborator
• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: collaborator
• Società Italiana di Anestesia, Rianimazione, Emergenza e Dolore (SIARED): collaborator
• Ass. Anestesisti Rianimatori Ospedalieri Italiani - Em. Area Crit. (AAROI-EMAC): collaborator
• Associazione Nazionale Infermieri di Area Critica (ANIARTI): collaborator

Study Sites (1)

AO San Paolo - Polo Universitario

Milan, 20142, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 10966293 RESULT

• 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.

  PMID: 11588447 RESULT

• 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.

  PMID: 17267907 RESULT

• 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.

  PMID: 23417207 RESULT

• 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.

  PMID: 27830281 RESULT

• 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.

  PMID: 31525488 DERIVED

MeSH Terms

Conditions

Critical Illness; Stress Disorders, Traumatic, Acute; Stress Disorders, Post-Traumatic; Communication

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Central Study Contacts

Giovanni Mistraletti

CONTACT

+39.339.8245014; giovanni.mistraletti@unimi.it

Maria Grazia Bocci

CONTACT

+39.340.9759951; mariagrazia.bocci@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Confirmed University Researcher / Assistant Professor San Paolo University Hospital, Milan

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

IT (1)