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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Groupe Hospitalier Paris Saint Joseph
Sponsor:
Collaborators:
Fondation de France
French Society for Intensive Care
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT01745406
First received: September 28, 2012
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition
Family Satisfaction
Healthcaregiver Satisfaction
Family PTSD
Family HADS
Family Traumatic Dissociation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU.

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Paris Saint Joseph:

Primary Outcome Measures:
  • Family satisfaction assessed by qualitative approach [ Time Frame: Patient's ICU discharge day (up to 3 months after Day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Healthcaregivers' satifaction assessed by qualitative approach [ Time Frame: End of the study (up to 2 years) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Family PTSD [ Time Frame: 3 months after patient's ICU discharge (up to 6 months after Day 1) ] [ Designated as safety issue: No ]
  • Family HADS [ Time Frame: 3 months after patient's ICU discharge (up to 6 months after Day 1) ] [ Designated as safety issue: No ]
  • Family peri-traumatic dissociation [ Time Frame: Patient's ICU discharge (up to 3 months after Day 1) ] [ Designated as safety issue: No ]

Estimated Enrollment: 74
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Doctor and nurse
Doctor without nurse

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Families of patients hospitalized in ICU.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745406

Contacts
Contact: Adeline max 0033144127082 adeline.max@gmail.com
Contact: Maïté Garrouste 0033144127718 mgarrouste@hpsj.fr

Locations
France
Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente Recruiting
Paris, France, 75014
Contact: Adeline Max    0033144127082    adeline.max@gmail.com   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Fondation de France
French Society for Intensive Care
  More Information

No publications provided

Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT01745406     History of Changes
Other Study ID Numbers: CPP/107-11
Study First Received: September 28, 2012
Last Updated: April 30, 2013
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Dissociative Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014