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

NCT03438175 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2100

Last updated 2018-05-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    collaborator OTHER
  • Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

    collaborator OTHER
  • Società Italiana di Anestesia, Rianimazione, Emergenza e Dolore (SIARED)

    collaborator UNKNOWN
  • Ass. Anestesisti Rianimatori Ospedalieri Italiani - Em. Area Crit. (AAROI-EMAC)

    collaborator UNKNOWN
  • Associazione Nazionale Infermieri di Area Critica (ANIARTI)

    collaborator UNKNOWN
  • University of Milan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03438175 on ClinicalTrials.gov