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Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits (PrEDDICT-PReV)

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ClinicalTrials.gov Identifier: NCT03423875
Recruitment Status : Unknown
Verified April 2019 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Recruiting
First Posted : February 6, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.


Condition or disease Intervention/treatment Phase
Delirium Diagnostic Test: PrEDICT game score Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

To prevent outcome assessment bias, research staff will be masked as to the randomization status of participants until after they have completed and recorded gold-standard delirium assessments of delirium using the Confusion Assessment Method .

Similarly, ED physicians will be blinded to the gold standard assessments of delirium made by research assistants as well as the results of the PrEDICT test scores when they make their baseline clinical assessments of delirium. ED Physicians will also remain masked until they have recorded their discharge plan. The intervention focuses on the impact of revealing the result of the PrEDICT game scores on ED physicians' recognition of delirium, so randomization status must be revealed to them.

Primary Purpose: Diagnostic
Official Title: Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits (PrEDDICT-PReV) App
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
No Intervention: Control
Patients assigned to the control condition will be treated using the current standard of care, clinical assessments, to identify delirium.
Experimental: Intervention
PrEDICTgame score (subject's relative risk of delirium) will be shared with ED physicians in the intervention arm. After viewing the tests results, ED physicians will be asked to reassess delirium risk, and indicate if they would change their management based on the PrEDICT app scores.
Diagnostic Test: PrEDICT game score
PrEDICT game score will be shared with the emergency physicians and health care professionals




Primary Outcome Measures :
  1. Delirium recognition by ED staff [ Time Frame: Delirium recognition by ED staff will be measured during their index ED visit, within 4 hours of assessment using the PrEDICT app. ]
    Design a simple dichotomous question to assess whether MD's clinically diagnose the presence of delirium in a specific patient(not delirious vs. delirious). In addition, ask MD's to rate their certainty of their diagnosis on a 10 point Numeric Rating scale. The primary outcome will be determined based on the dichotomous question


Secondary Outcome Measures :
  1. Ability of the PrEDICT app to identify patients with incident delirium [ Time Frame: Between 7-14 days of ED discharge ]
    Our Secondary outcome will be to correlate the PrEDICT game score with patients who develop incident delirium as assessed using the CAM

  2. Ability of the PrEDICT app to identify patients at high risk for incident delirium [ Time Frame: Between 7-14 days of ED discharge ]
    Our Secondary outcome will be to correlate the PrEDICT game score with patients who develop incident delirium as assessed using delirium index

  3. Unanticipated Barriers to using the PrEDICT app [ Time Frame: Day 1(ED visit) to Day 4 ]
    Clinical feasibility will be assessed as the proportion of eligible patients that are able to complete use of the PrEDICT serious game.

  4. Feasibility of Tablet Administration by Other Stakeholders [ Time Frame: Day 1(ED visit) to Day 4 ]
    In patients who have already completed the main study and primary outcome, a convenience subsample will be recruited to compare the relative completion rate of the PrEDICT app by patients who are being supervised by: i) nurses; ii) trained hospital volunteers; and iii) family members and care givers.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423875


Contacts
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Contact: Jacques S Lee, MD 416-480-6100 ext 7701 jacques.lee@sunnybrook.ca
Contact: Joanna Yeung, HBSc 416-480-6100 ext 7702 joanna.yeung@sunnybrook.ca

Locations
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Canada, Halifax
Nova Scotia Health Authority Recruiting
Nova Scotia, Halifax, Canada
Contact: Judah Goldstein         
Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Cathy Clement         
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Joanna Yeung         
Canada, Quebec
CHU de Québec - Université Laval Recruiting
Québec, Quebec, Canada, G1J 1Z4
Contact: Valérie Boucher         
Canada
Alberta Health Services Recruiting
Calgary, Canada
Contact: Hina Walia         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Publications:

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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03423875    
Other Study ID Numbers: 269-2017
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Delirium, Delirium Recognition
Additional relevant MeSH terms:
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Delirium
Emergencies
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders