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

Family Satisfaction Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745406
• Other study ID #: CPP/107-11
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: August 6, 2015
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2013
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Family HADS
• Family PTSD
• Family Satisfaction
• Family Traumatic Dissociation
• Healthcaregiver Satisfaction

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph	Fondation de France, French Society for Intensive Care

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family PTSD		3 months after patient's ICU discharge (up to 6 months after Day 1)	No
Other	Family HADS		3 months after patient's ICU discharge (up to 6 months after Day 1)	No
Other	Family peri-traumatic dissociation		Patient's ICU discharge (up to 3 months after Day 1)	No
Primary	Family satisfaction assessed by qualitative approach		Patient's ICU discharge day (up to 3 months after Day 1)	No
Secondary	Healthcaregivers' satifaction assessed by qualitative approach		End of the study (up to 2 years)	No