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

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.

Study Overview

• Status: Completed
• Conditions: Family Satisfaction; Healthcaregiver Satisfaction; Family PTSD; Family HADS; Family Traumatic Dissociation

Detailed Description

-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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Families of patients hospitalized in ICU.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Conflict, organ donor, refusal to participate.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Doctor and nurse
Doctor without nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Family satisfaction assessed by qualitative approach	Patient's ICU discharge day (up to 3 months after Day 1)

Secondary Outcome Measures

Outcome Measure	Time Frame
Healthcaregivers' satifaction assessed by qualitative approach	End of the study (up to 2 years)

Other Outcome Measures

Outcome Measure	Time Frame
Family PTSD	3 months after patient's ICU discharge (up to 6 months after Day 1)
Family HADS	3 months after patient's ICU discharge (up to 6 months after Day 1)
Family peri-traumatic dissociation	Patient's ICU discharge (up to 3 months after Day 1)

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph
• Collaborators: French Society for Intensive Care; Fondation de France

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: September 28, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 6, 2015
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Dissociative Disorders
• Other Study ID Numbers: CPP/107-11