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

NCT01745406 | Completed DMC

• 1 other identifier: CPP/107-11
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Family Satisfaction; Healthcaregiver Satisfaction; Family PTSD; Family HADS; Family Traumatic Dissociation

Outcome Measures

Primary Outcomes (1)

• Family satisfaction assessed by qualitative approach

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

Secondary Outcomes (1)

• Healthcaregivers' satifaction assessed by qualitative approach

  End of the study (up to 2 years)

Other Outcomes (3)

• 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)

Study Arms (2)

Doctor and nurse

Doctor without nurse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Families of patients hospitalized in ICU.

You may qualify if:

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

You may not qualify if:

• Conflict, organ donor, refusal to participate.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Fondation de France: collaborator
• French Society for Intensive Care: collaborator

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente

Paris, 75014, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: December 10, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 7, 2015

Record last verified: 2013-04

Locations

FR (1)