Skip to main content
Clinical Trials/NCT02931851
NCT02931851
Terminated
Not Applicable

Family Information Management in the Intensive Care Unit: A Randomized Controlled Trial

Medical University of Graz3 sites in 2 countries75 target enrollmentMay 1, 2015
ConditionsExtended Family

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extended Family
Sponsor
Medical University of Graz
Enrollment
75
Locations
3
Primary Endpoint
Subjective distress
Status
Terminated
Last Updated
3 years ago

Overview

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.

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?

Registry
clinicaltrials.gov
Start Date
May 1, 2015
End Date
December 15, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medical University of Graz
Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

Subjective distress

Time Frame: 30 Days

Impact of Event Score (IES: symptoms of post traumatic stress disorder)

Secondary Outcomes

  • Subjective usefulness of the website for relatives(30 days)
  • Length of stay(90 days)
  • Mortality(90 days)
  • Readmissions(90 days)
  • User-statistics(30 days)
  • Levels of anxiety and depression(30 days)

Study Sites (3)

Loading locations...

Similar Trials