- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02931851
Family Information Management in the Intensive Care Unit (ICU-Families)
Family Information Management in the Intensive Care Unit: A Randomized Controlled Trial
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Design:
- Phase: Empirical study (quantitative) of information needs - semi-structured interviews with family members, physicians and caregivers
- Phase: Development of user friendly homepage with University of Applied Sciences Joanneum and validation of the homepage with medical professionals and laypersons
- 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?
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Placebo
Standard Information
|
Standard Information provided online
|
|
Comparatore attivo: Intervention
Professionally developed website for relatives of ICU patients
|
Professionally developed website for relatives of ICU patients
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Subjective distress
Lasso di tempo: 30 Days
|
Impact of Event Score (IES: symptoms of post traumatic stress disorder)
|
30 Days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Levels of anxiety and depression
Lasso di tempo: 30 days
|
Measured by Hospital Anxiety and Depression Score (HADS)
|
30 days
|
|
Subjective usefulness of the website for relatives
Lasso di tempo: 30 days
|
Subjective Evaluation
|
30 days
|
|
Length of stay
Lasso di tempo: 90 days
|
ICU and Hospital length of stay of the index patients
|
90 days
|
|
Readmissions
Lasso di tempo: 90 days
|
number of readmissions of the index patients
|
90 days
|
|
Mortality
Lasso di tempo: 90 days
|
mortality of the index patients
|
90 days
|
|
User-statistics
Lasso di tempo: 30 days
|
user statistics for the website
|
30 days
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Karin Amrein, MD, MSc, Medical University of Graz
Pubblicazioni e link utili
Pubblicazioni generali
- 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. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.
- 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.
- 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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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- ICU-Families 1.0
Piano per i dati dei singoli partecipanti (IPD)
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