Family Information Management in the Intensive Care Unit (ICU-Families)

• ClinicalTrials.gov Identifier: NCT02931851
• Recruitment Status: Suspended
• First Posted: October 13, 2016
• Last Update Posted: January 5, 2021
• Sponsor: Medical University of Graz
• Collaborators: Medical University of Vienna; University Hospital Inselspital, Berne
• Information provided by (Responsible Party): Medical University of Graz

Study Description

Brief Summary:

Relatives in intensive care units (ICU) are important partners in decision-making in the treatment of critically ill patients and provide a significant resource in the care and recovery of patients. Therefore, a professional, educational intervention targeting these caregivers may have fundamental benefits with little risk. As in other fields, information is searched in the internet, but this unselected information is often overwhelming and of little use in this context.

Symptoms of anxiety, stress and depression are common in affected relatives. The majority of family members report some level of anxiety, depression and stress, sometimes even resulting in post-traumatic stress disorder (PTSD). Importantly, an association between lack of information and post-traumatic stress disorder PTSD has been reported. The large number of potentially affected families poses a particular challenge to healthcare and may cause substantial secondary costs to national economy.

Condition or disease	Intervention/treatment	Phase
Extended Family	Other: ICU Families Website; Other: Placebo	Not Applicable

Detailed Description:

Design:

1. Phase: Empirical study (quantitative) of information needs - semi-structured interviews with family members, physicians and caregivers
2. Phase: Development of user friendly homepage with University of Applied Sciences Joanneum and validation of the homepage with medical professionals and laypersons
3. Phase: Randomized Controlled Trial (non-blinded) with "placebo home page" (N=110)

Background:

Relatives in intensive care units (ICU) are important partners in decision-making in the treatment of critically ill patients and provide a significant resource in the care and recovery of patients. Therefore, a professional, educational intervention targeting these caregivers may have fundamental benefits with little to no risk. As in other fields, information is searched in the internet, but this unselected information is often overwhelming and of little use in this context.

In Austria there are 2784 systemized intensive care beds with an average occupation of 3,6 days, representing 100 new admissions per year/ICU bed. This may translate to 500.000 affected family members per year.

The role of family members in the treatment process of ICU patients is a not very well studied subject, especially in German-speaking countries. In contrast, in the Anglo-American world, family members play a key role in the medical, financial and legal aspects of the treatment process and have a decisive role in the successful treatment during and after critical illness.

Symptoms of anxiety, stress and depression are common in affected relatives . The majority of family members report some level of anxiety, depression and stress, sometimes even resulting in post-traumatic stress disorder (PTSD). Importantly, an association between lack of information and post-traumatic stress disorder PTSD has been reported. The large number of potentially affected families poses a particular challenge to healthcare and may cause substantial secondary costs to national economy.

The participation of relatives in the decision making process of ICU patients is negatively affected by the uncertainty concerning the treatment path, medical procedures and consequences for the families' life after ICU discharge. This likely leads to unnecessary hospital readmissions, complicates rehabilitation of patients and requires adapted management strategies for relatives. Therefore, it is important to provide sufficient information to families in high quality.

The relationship management with relatives places significant demands on ICU staff and conflicts between physicians and relatives are common. So far, only a few randomized intervention studies have been performed in this setting, but with promising results.

The internet has revolutionized our world including the access to medical information. In one study, almost 50% of ICU patients' family members used the internet for information purposes within the first days of ICU treatment. This makes a web-based intervention in this setting very promising. To our knowledge however, no RCT has yet evaluated the usefulness of a web-based intervention on ICU patients' family members' quality of life.

The following question should therefore be answered by our study:

• Does targeted information and communication using new media (INTERVENTION) have a beneficial influence on subjective and objective endpoints of patients and their families?
• Could this help in averting the negative effects of anxiety, stress, and depression? Are new media accepted in clinical routine?
• Does the project support the affected family members in their health literacy?

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Family Information Management in the Intensive Care Unit: A Randomized Controlled Trial
• Actual Study Start Date: May 1, 2015
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: July 2021

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Standard Information	Other: Placebo; Standard Information provided online
Active Comparator: Intervention; Professionally developed website for relatives of ICU patients	Other: ICU Families Website; Professionally developed website for relatives of ICU patients

Outcome Measures

Primary Outcome Measures :

1. Subjective distress [ Time Frame: 30 Days ]
   Impact of Event Score (IES: symptoms of post traumatic stress disorder)

Secondary Outcome Measures :

1. Levels of anxiety and depression [ Time Frame: 30 days ]
   Measured by Hospital Anxiety and Depression Score (HADS)
2. Subjective usefulness of the website for relatives [ Time Frame: 30 days ]
   Subjective Evaluation
3. Length of stay [ Time Frame: 90 days ]
   ICU and Hospital length of stay of the index patients
4. Readmissions [ Time Frame: 90 days ]
   number of readmissions of the index patients
5. Mortality [ Time Frame: 90 days ]
   mortality of the index patients
6. User-statistics [ Time Frame: 30 days ]
   user statistics for the website

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• anticipated further ICU stay ≥3 days (index patient)

Exclusion Criteria:

• lack of Basic Information Technology (IT) user knowledge or German language skills
• DNR (Do not resuscitate) orders (index patient)

Contacts and Locations

Locations

Austria

Medical University of Graz

Graz, Austria, 8036

Medical University of Vienna

Vienna, Austria

Switzerland

University of Berne - Inselspital

Bern, Switzerland

Sponsors and Collaborators

Medical University of Graz

Medical University of Vienna

University Hospital Inselspital, Berne

Investigators

• Principal Investigator: Karin Amrein, MD, MSc; Medical University of Graz

More Information

Publications:

Azoulay E, Kentish-Barnes N, Nelson JE. Communication With Family Caregivers in the Intensive Care Unit: Answers and Questions. JAMA. 2016 May 17;315(19):2075-7. doi: 10.1001/jama.2016.5637.

Peigne V, Chaize M, Falissard B, Kentish-Barnes N, Rusinova K, Megarbane B, Bele N, Cariou A, Fieux F, Garrouste-Orgeas M, Georges H, Jourdain M, Kouatchet A, Lautrette A, Legriel S, Regnier B, Renault A, Thirion M, Timsit JF, Toledano D, Chevret S, Pochard F, Schlemmer B, Azoulay E. Important questions asked by family members of intensive care unit patients. Crit Care Med. 2011 Jun;39(6):1365-71. doi: 10.1097/CCM.0b013e3182120b68.

Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

• Responsible Party: Medical University of Graz
• ClinicalTrials.gov Identifier: NCT02931851
• Other Study ID Numbers: ICU-Families 1.0
• First Posted: October 13, 2016
• Last Update Posted: January 5, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No