Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE) (INVOLVE)
A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill
Each year, millions of Americans are admitted to an intensive care unit (ICU). For more than half of them, ICU admission initiates a cascade of decisions about treatment and end-of-life care.This is particularly the case for patients with chronic critical illness, a life-limiting syndrome. Most (74%-82%) ICU patients who require mechanical ventilation have transient or persistent cognitive impairment that precludes them from making their own healthcare decisions. Among ICU patients, the chronically critically ill (CCI) are at highest risk for cognitive impairment and thus require a surrogate decision maker (SDM), usually a family member. SDMs for the critically ill often describe high states of psychological stress associated with the uncertainty of the patient's condition and their decision making role.
The purpose of this study is to test the effectiveness of two decision support interventions for end-of-life care delivered to SDMs of CCI patients. This will be the first study to test interventions tailored to the unique needs of the SDMs of CCI patients delivered using an interactive avatar based format.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The investigators will conduct a three-arm unblinded clinical trial using pre- and post-tests to evaluate the efficacy of two electronic decision-support interventions, Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE) and Informational Support (IS), compared to each other and to usual care (UC) among 270 SDMs of cognitively impaired CCI patients. This design will allow the investigators to prospectively compare the efficacy of the experiential avatar-based decision support tool (INVOLVE) with both an information-only condition and UC. Subjects assigned to an experimental condition (INVOLVE or IS) will receive two doses of the intervention, at enrollment and 1 day later. After the second dose, these subjects will have access to their assigned condition for subsequent self-administered doses, which will be electronically captured until the patient's ICU discharge or death. Data will be collected at (T1) baseline (Day 3 or 4 of the patient's ICU stay), and then on Days 1, 3, 7 and 90 post-baseline
.
The investigators aim to:
- Identify the essential elements of the graphical user interface and educational content needed to revise the INVOLVE prototype for a set of common end-of-life decisions that occur in the ICU.
- Evaluate if there are differences in the decision making readiness and decision making quality between subjects exposed to INVOLVE, IS, or UC on Days 1, 3, and 7 days post-baseline while accounting for covariates (prior SDM experience, SDM knowledge of the patient's preferences, and SDM's religious beliefs).
- Determine if there are differences in the post-decision outcomes of SDMs and their CCI patient by study condition while accounting for covariates at 90 days post-baseline.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44106
- University Hospitals Case Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Eligibility criteria for CCI patients:
- aged 18 years or older
- required mechanical ventilation and ICU stay for greater than or equal to 3 days
- not expected to be transferred out of the ICU within 48 hours
- lacks cognitive capacity, as determined by a Glasgow Coma Scale eye score of less than 3 or the motor score less than 6 and verifying the status by asking the patients's attending physician or advanced practice nurse whether he or she would obtain consent from the patient or a family member
- has an identified SDM (next-of-kin or legal representative for healthcare decision making).
Eligibility criteria for SDMs:
- aged 18 years or older
- identified by the healthcare team as the patient's next of kin or legal representative for healthcare decision making
- able to speak and understand English
- able to view images on an 10-inch computer screen and hear audio through a standard set of headphones.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: INVOLVE
The first study condition, called "Interactive Virtual Decision Support for End-of-Life and Palliative Care (INVOLVE)" will consist of exposures to an avatar-based decision support technology that will be administered via tablet computer and allow SDMs opportunities to practice their communication and decision making skills through interactions with avatars that portray a decision coach and various healthcare providers.
|
Interactive content and decision coaching with tailored framing of messages to subject's informational processing style and stage of change to promote participatory decision making behavior.
Consideration of options, consequences, values, and preferences to formulate an informed decision.
|
|
Sperimentale: Informational Support
The second condition, called Informational Support (IS), will also be administered via tablet computers and expose SDMs to educational resources of INVOLVE without the experiential components.
|
Passive, non-tailored informational support.
Screen-based education (videos) with information content on advance care decisions that occur in the intensive care unit.
|
|
Sperimentale: Usual Care
The third condition, usual care (UC), will expose SDMs to the routine communication and decisional support practices provided by the healthcare team.
|
Routine decision support practices by the healthcare team.
Family meetings, bedside updates, and access to printed or electronic decision aids.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Repeated Measures
Lasso di tempo: From (T1) baseline through (T5) 90 days post-baseline
|
ANOVA Model (F-Statistic)
|
From (T1) baseline through (T5) 90 days post-baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Preparation for Decision Making Scale
Lasso di tempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Decision Making Preparedness
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Family Decision Making Self-Efficacy Scale
Lasso di tempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Decision Making Self-Efficacy
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Single item measure of Role Stress
Lasso di tempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Decisional Role Stress
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Decision Conflict Scale
Lasso di tempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Decision Conflict
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Modified Control Preferences Scale
Lasso di tempo: (T1) baseline through (T4) 7 days post-baseline
|
Measure of Behavioral Activation
|
(T1) baseline through (T4) 7 days post-baseline
|
|
Change in Decision Regret Scale
Lasso di tempo: (T1) baseline and (T5) 90 days post-baseline
|
Measure of Decision Regret
|
(T1) baseline and (T5) 90 days post-baseline
|
|
Change in Hospital Anxiety and Depression Scale
Lasso di tempo: (T1) baseline and (T5) 90 days post-baseline
|
Measure of Anxiety and Depressive Symptoms
|
(T1) baseline and (T5) 90 days post-baseline
|
Collaboratori e investigatori
Pubblicazioni e link utili
Studiare le date dei record
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 (Effettivo)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 08-16-25
- 5R01NR015750-02 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .