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

13 juni 2022 uppdaterad av: Medical University of Graz

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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?

Studietyp

Interventionell

Inskrivning (Faktisk)

75

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Bern, Schweiz
        • University of Berne - Inselspital
      • Graz, Österrike, 8036
        • Medical University of Graz
      • Vienna, Österrike
        • Medical University of Vienna

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
Standard Information
Standard Information provided online
Aktiv komparator: Intervention
Professionally developed website for relatives of ICU patients
Professionally developed website for relatives of ICU patients

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Subjective distress
Tidsram: 30 Days
Impact of Event Score (IES: symptoms of post traumatic stress disorder)
30 Days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Levels of anxiety and depression
Tidsram: 30 days
Measured by Hospital Anxiety and Depression Score (HADS)
30 days
Subjective usefulness of the website for relatives
Tidsram: 30 days
Subjective Evaluation
30 days
Length of stay
Tidsram: 90 days
ICU and Hospital length of stay of the index patients
90 days
Readmissions
Tidsram: 90 days
number of readmissions of the index patients
90 days
Mortality
Tidsram: 90 days
mortality of the index patients
90 days
User-statistics
Tidsram: 30 days
user statistics for the website
30 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Karin Amrein, MD, MSc, Medical University of Graz

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2015

Primärt slutförande (Faktisk)

15 december 2020

Avslutad studie (Faktisk)

15 december 2020

Studieregistreringsdatum

Först inskickad

11 oktober 2016

Först inskickad som uppfyllde QC-kriterierna

11 oktober 2016

Första postat (Uppskatta)

13 oktober 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 juni 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juni 2022

Senast verifierad

1 juni 2022

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • ICU-Families 1.0

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

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