Clinical trial NCT03423875: Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits
Official title: Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits (PrEDDICT-PReV) App
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Keywords: Delirium, Delirium Recognition
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 1375
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Delirium is a common and serious complication of medical care that affects 10% of older Emergency Department (ED) patients, which unfortunately is unrecognized in up to 75% of ED patients.Studies have shown that 26 - 42% of patient with delirium are sent home. And 80% of patients sent home with unrecognized delirium are re-hospitalized within 4 days. Unrecognized delirium also has grave consequences for patient care - Kakuma showed that patient with unrecognized delirium who were sent home had 3-8x the mortality rate of patients with recognized delirium at 6 months.

Fluctuating severity over time is a key clinical characteristics of delirium, making its diagnosis challenging. Regardless of cause, failure to recognize delirium means that ED staff cannot meet their patient"s needs. For example, ED staff may miss serious medical conditions associated with delirium, may not provide understandable discharge instructions or ensure a caregiver can supervise and assist a patient with delirium who is discharged. These care adaptations require staff to recognize the presence of delirium. Thus it is not surprising that unrecognized delirium has such grave consequences for patients.

Thus recognition of delirium is critical to improving patient outcomes and reducing repeat ED visits. Patients with delirium may appear to have normal mental status at times, making its diagnosis challenging. High levels of service demand in the ED, plus the competing demands of numerous other initiatives to improve quality and reduce waiting times may explain why delirium continue to go unrecognized despite guidelines promoting routine delirium screening as a top priority in the ED. To address this care gap, the investigators developed an innovative solution. Rather than adding tasks to overburdened ED staff, our solution takes advantage of the long waiting times clients have in the ED for their initial assessments and between interactions with clinical staff. During these times, patients will use the PrEDICT "serious game" - similar to the Whack-a-Mole carnival game. The investigators have developed an algorithm based on participants" performance on this simple but serious game that can identify patients at high risk for delirium.

The investigators propose to conduct a prospective, multi-center randomized clinical trial in 4 provinces. The primary objective of this study is to assess the impact of our tablet technology on the recognition of delirium by ED staff. All eligible patients who agree to participate will be treated in the same manner and will play the PrEDICT tablet based game. The investigators will randomly assign half of patients to have their test performance shared with clinical staff. Patients assigned to the control condition will be treated using the current standard of care, clinical assessments, to identify delirium.

This project will allow us to solidly advance this technology from a working prototype (TRL7) to a commercially ready product demonstrated effective in multiple "real-world" environments under expected operational conditions (TRL8). Also it will provide evidence that the PrEDICT tablet app is clinically, technically, commercially and operationally feasible.


Eligibility criteria: Inclusion Criteria:

* 65 years of age and older
* Have been in the ED for a minimum of 4 hours at the time of screening

Exclusion Criteria:

* Live in a full care nursing home
* Have a critical illness (Canadian Triage Acuity Score rendering them unable to communicate or provide consent)
* Have delirium prior to ED arrival
* Do not assent to study participation
* Have visual impairment that makes them unable to use the serious game tablet
* Have other communication difficulties preventing use of the serious game tablet

Primary outcomes:
measure: Delirium recognition by ED staff
timeFrame: Delirium recognition by ED staff will be measured during their index ED visit, within 4 hours of assessment using the PrEDICT app.
Secondary outcomes:
measure: Ability of the PrEDICT app to identify patients with incident delirium
timeFrame: Between 7-14 days of ED discharge
measure: Ability of the PrEDICT app to identify patients at high risk for incident delirium
timeFrame: Between 7-14 days of ED discharge
measure: Unanticipated Barriers to using the PrEDICT app
timeFrame: Day 1(ED visit) to Day 4
measure: Feasibility of Tablet Administration by Other Stakeholders
timeFrame: Day 1(ED visit) to Day 4
Other outcomes:
Locations:
city: Nova Scotia
country: Canada
facility: Nova Scotia Health Authority
state: Halifax
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Québec
country: Canada
facility: CHU de Québec - Université Laval
state: Quebec
city: Calgary
country: Canada
facility: Alberta Health Services
Study officials:
References:
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