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| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Standard Information |
|
| Intervention | Active Comparator | Professionally developed website for relatives of ICU patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICU Families Website | Other | Professionally developed website for relatives of ICU patients |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective distress | Impact of Event Score (IES: symptoms of post traumatic stress disorder) | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of anxiety and depression | Measured by Hospital Anxiety and Depression Score (HADS) | 30 days |
| Subjective usefulness of the website for relatives | Subjective Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Amrein, MD, MSc | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Graz | 8036 | Austria | |||
| Medical University of Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27187298 | Background | 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. No abstract available. | |
| 21358395 | Background | 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. |
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| Placebo |
| Other |
Standard Information provided online |
|
| 30 days |
| Length of stay | ICU and Hospital length of stay of the index patients | 90 days |
| Readmissions | number of readmissions of the index patients | 90 days |
| Mortality | mortality of the index patients | 90 days |
| User-statistics | user statistics for the website | 30 days |
| Vienna |
| Austria |
| University of Berne - Inselspital | Bern | Switzerland |
| 17267907 | Background | 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. doi: 10.1056/NEJMoa063446. |
| 37870597 | Derived | Hoffmann M, Jeitziner MM, Riedl R, Mueller G, Peer A, Bachlechner A, Heindl P, Burgsteiner H, Schefold JC, von Lewinski D, Eller P, Pieber T, Sendlhofer G, Amrein K. Effects of an online information tool on post-traumatic stress disorder in relatives of intensive care unit patients: a multicenter double-blind, randomized, placebo-controlled trial (ICU-Families-Study). Intensive Care Med. 2023 Nov;49(11):1317-1326. doi: 10.1007/s00134-023-07215-4. Epub 2023 Oct 23. |