Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits

Delirium Clinical Trial

— PrEDDICT-PReV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03423875
• Other study ID #: 269-2017
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 2020

Study information

• Verified date: April 2019
• Source: Sunnybrook Health Sciences Centre
• Contact: Jacques S Lee, MD
• Phone: 416-480-6100
• Email: jacques.lee[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1375
• Est. completion date: March 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergencies

Intervention

Diagnostic Test:
• PrEDICT game score
PrEDICT game score will be shared with the emergency physicians and health care professionals

Locations

Country	Name	City	State
Canada	Alberta Health Services	Calgary
Canada	Nova Scotia Health Authority	Nova Scotia	Halifax
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	CHU de Québec - Université Laval	Québec	Quebec
Canada	Sunnybrook Research Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (17)

Adamis D, Treloar A, Darwiche FZ, Gregson N, Macdonald AJ, Martin FC. Associations of delirium with in-hospital and in 6-months mortality in elderly medical inpatients. Age Ageing. 2007 Nov;36(6):644-9. Epub 2007 Jul 28. — View Citation

Carpenter CR, Bassett ER, Fischer GM, Shirshekan J, Galvin JE, Morris JC. Four sensitive screening tools to detect cognitive dysfunction in geriatric emergency department patients: brief Alzheimer's Screen, Short Blessed Test, Ottawa 3DY, and the caregiver-completed AD8. Acad Emerg Med. 2011 Apr;18(4):374-84. doi: 10.1111/j.1553-2712.2011.01040.x. — View Citation

Elie M, Rousseau F, Cole M, Primeau F, McCusker J, Bellavance F. Prevalence and detection of delirium in elderly emergency department patients. CMAJ. 2000 Oct 17;163(8):977-81. — View Citation

Han JH, Zimmerman EE, Cutler N, Schnelle J, Morandi A, Dittus RS, Storrow AB, Ely EW. Delirium in older emergency department patients: recognition, risk factors, and psychomotor subtypes. Acad Emerg Med. 2009 Mar;16(3):193-200. doi: 10.1111/j.1553-2712.2008.00339.x. Epub 2009 Jan 20. — View Citation

Hustey FM, Meldon S, Palmer R. Prevalence and documentation of impaired mental status in elderly emergency department patients. Acad Emerg Med. 2000 Oct;7(10):1166. — View Citation

Hustey FM, Meldon SW, Smith MD, Lex CK. The effect of mental status screening on the care of elderly emergency department patients. Ann Emerg Med. 2003 May;41(5):678-84. — View Citation

Hustey FM, Meldon SW. The prevalence and documentation of impaired mental status in elderly emergency department patients. Ann Emerg Med. 2002 Mar;39(3):248-53. — View Citation

Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. — View Citation

Kakuma R, du Fort GG, Arsenault L, Perrault A, Platt RW, Monette J, Moride Y, Wolfson C. Delirium in older emergency department patients discharged home: effect on survival. J Am Geriatr Soc. 2003 Apr;51(4):443-50. — View Citation

Lewis LM, Miller DK, Morley JE, Nork MJ, Lasater LC. Unrecognized delirium in ED geriatric patients. Am J Emerg Med. 1995 Mar;13(2):142-5. — View Citation

McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern Med. 2002 Feb 25;162(4):457-63. — View Citation

McCusker J, Cole MG, Dendukuri N, Belzile E. The delirium index, a measure of the severity of delirium: new findings on reliability, validity, and responsiveness. J Am Geriatr Soc. 2004 Oct;52(10):1744-9. — View Citation

Monette J, Galbaud du Fort G, Fung SH, Massoud F, Moride Y, Arsenault L, Afilalo M. Evaluation of the Confusion Assessment Method (CAM) as a screening tool for delirium in the emergency room. Gen Hosp Psychiatry. 2001 Jan-Feb;23(1):20-5. — View Citation

Schuurmans MJ, Duursma SA, Shortridge-Baggett LM. Early recognition of delirium: review of the literature. J Clin Nurs. 2001 Nov;10(6):721-9. Review. — View Citation

Sylvestre MP, McCusker J, Cole M, Regeasse A, Belzile E, Abrahamowicz M. Classification of patterns of delirium severity scores over time in an elderly population. Int Psychogeriatr. 2006 Dec;18(4):667-80. Epub 2006 Apr 27. — View Citation

Wilber ST, Carpenter CR, Hustey FM. The Six-Item Screener to detect cognitive impairment in older emergency department patients. Acad Emerg Med. 2008 Jul;15(7):613-6. doi: 10.1111/j.1553-2712.2008.00158.x. — View Citation

Zou Y, Cole MG, Primeau FJ, McCusker J, Bellavance F, Laplante J. Detection and diagnosis of delirium in the elderly: psychiatrist diagnosis, confusion assessment method, or consensus diagnosis? Int Psychogeriatr. 1998 Sep;10(3):303-8. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium recognition by ED staff	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	Delirium recognition by ED staff will be measured during their index ED visit, within 4 hours of assessment using the PrEDICT app.
Secondary	Ability of the PrEDICT app to identify patients with incident delirium	Our Secondary outcome will be to correlate the PrEDICT game score with patients who develop incident delirium as assessed using the CAM	Between 7-14 days of ED discharge
Secondary	Ability of the PrEDICT app to identify patients at high risk for incident delirium	Our Secondary outcome will be to correlate the PrEDICT game score with patients who develop incident delirium as assessed using delirium index	Between 7-14 days of ED discharge
Secondary	Unanticipated Barriers to using the PrEDICT app	Clinical feasibility will be assessed as the proportion of eligible patients that are able to complete use of the PrEDICT serious game.	Day 1(ED visit) to Day 4
Secondary	Feasibility of Tablet Administration by Other Stakeholders	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.	Day 1(ED visit) to Day 4