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

NCT ID: NCT01745406

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Doctor and nurse

No interventions assigned to this group

Doctor without nurse

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation de France

OTHER

Sponsor Role: collaborator

French Society for Intensive Care

OTHER

Sponsor Role: collaborator

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente

Paris, , France

Countries

France

Other Identifiers

CPP/107-11

Identifier Type: -

Identifier Source: org_study_id