Clinical trial NCT01745406: Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU.
Official title: Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Family Satisfaction
Healthcaregiver Satisfaction
Family PTSD
Family HADS
Family Traumatic Dissociation
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
Collaborators: name: Fondation de France
name: French Society for Intensive Care
First posted: 2012-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Families of patients hospitalized in ICU.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Family satisfaction assessed by qualitative approach
timeFrame: Patient's ICU discharge day (up to 3 months after Day 1)
Secondary outcomes:
measure: Healthcaregivers' satifaction assessed by qualitative approach
timeFrame: End of the study (up to 2 years)
Other outcomes:
measure: Family PTSD
timeFrame: 3 months after patient's ICU discharge (up to 6 months after Day 1)
measure: Family HADS
timeFrame: 3 months after patient's ICU discharge (up to 6 months after Day 1)
measure: Family peri-traumatic dissociation
timeFrame: Patient's ICU discharge (up to 3 months after Day 1)
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente
Study officials:
References: