Skip to main content
OpenTrials
Completed

NCT Number: NCT01745406

Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU.

When a patient is admitted to the ICU this often happens so suddenly that this can create a significant amount of stress and anxiety for family members for several reasons. Firstly, the family does not have a pre existing relationship with the ICU team. Secondly, the urgency of the situation and the technic it requires is often such that minimal information can be given to family members. And finally, as a result of the unpredictability of each patient's condition, it can be difficult to predict outcome for family members. Together, these factors compound the stress and anxiety of family members. This anxiety is natural and it is important for health caregivers to be able to offer the best support possible. A high quality communication provided by structured information given by physicians and nurses as well could improve support to the families and lead to greater satisfaction.

Giving information to families during meetings is crucial at 3 moments: at the first day when the patient is admitted, at day 3, weekly and each time important news is given (surgery, deterioration in condition, end-of-life).

The purpose of this project is to evaluate if the involvement of nurses during those meetings could improve quality in communication which is assessed by mixed methods. Families and healthcare workers satisfaction will be assessed by qualitative methodology. Family peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using validated scales.

Training of healthcare workers will be done by role play. Information to the families is delivered using a framework for physicians and nurses. All the meetings of the study will be audited by a psychologist.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente

Paris, 75014, France

About this study

-Randomized trial with two arms: arm 1: information is delivered by a team (physician and nurse) arm 2: information is delivered by the physician alone

-During the different meetings of the study: at day 1, at day 3, weekly and in case of deterioration of the patient condition.

The other days, family information is delivered as usually in both arms.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient : adult, 1 relative at minimum, mechanically ventilated at least 48 hours; and
  • family : french-speaking, adult;

Exclusion criteria

  • Conflict, organ donor, refusal to participate.

Treatment and study plan

Primary outcomes

  1. Family satisfaction assessed by qualitative approach

    Time frame: Patient's ICU discharge day (up to 3 months after Day 1)

Secondary outcomes

  1. Healthcaregivers' satifaction assessed by qualitative approach

    Time frame: End of the study (up to 2 years)

Other outcomes

  1. Family PTSD

    Time frame: 3 months after patient's ICU discharge (up to 6 months after Day 1)

  2. Family HADS

    Time frame: 3 months after patient's ICU discharge (up to 6 months after Day 1)

  3. Family peri-traumatic dissociation

    Time frame: Patient's ICU discharge (up to 3 months after Day 1)

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Collaborators

  • Fondation de France
  • French Society for Intensive Care

Registry information

Acronym: NEWS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 10, 2012
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.