An interventional study of ICU Families Website and Placebo in Extended Family, sponsored by Medical University of Graz. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Prevention
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.
Design:
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:
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Exclusion Criteria:
Standard Information
Other: Placebo
Professionally developed website for relatives of ICU patients
Other: ICU Families Website
Professionally developed website for relatives of ICU patients
Standard Information provided online
Subjective distress
Impact of Event Score (IES: symptoms of post traumatic stress disorder)
Time frame: 30 Days
Levels of anxiety and depression
Measured by Hospital Anxiety and Depression Score (HADS)
Time frame: 30 days
Subjective usefulness of the website for relatives
Subjective Evaluation
Time frame: 30 days
Length of stay
ICU and Hospital length of stay of the index patients
Time frame: 90 days
Readmissions
number of readmissions of the index patients
Time frame: 90 days
Mortality
mortality of the index patients
Time frame: 90 days
User-statistics
user statistics for the website
Time frame: 30 days
Plan to share: Undecided
This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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