DeliriumPrEDDICT-PReVNCT03423875
Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits
A study testing PrEDICT game score in people with Delirium, run by Sunnybrook Health Sciences Centre at 5 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- PrEDICT game score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,375 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Mar 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age and older
- Have been in the ED for a minimum of 4 hours at the time of screening
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Alberta Health Services
Calgary
Hina Walia
- Recruiting
Nova Scotia Health Authority
Nova Scotia, Halifax
Judah Goldstein
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
Cathy Clement
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec, G1J 1Z4
Valérie Boucher
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N3M5
Joanna Yeung
About this study
Official title: Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits (PrEDDICT-PReV) App
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.
Read more
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.
- Conditions
- Delirium
- Being tested
- PrEDICT game score
- Keywords
- Delirium, Delirium Recognition
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEDICT game scoreDiagnostic test
PrEDICT game score will be shared with the emergency physicians and health care professionals
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients assigned to the control condition will be treated using the current standard of care, clinical assessments, to identify delirium. |
| Intervention | Experimental | 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. Receives: Diagnostic Test: PrEDICT game score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Delirium recognition by ED staff will be measured during their index ED visit, within 4 hours of assessment using the PrEDICT app.
Secondary outcomes (4)
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
Measured: Between 7-14 days of ED discharge
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
Measured: Between 7-14 days of ED discharge
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.
Measured: Day 1(ED visit) to Day 4
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.
Measured: Day 1(ED visit) to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Mar 2018
- Primary completionJan 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423875
- Sponsor's protocol ID
- 269-2017
- Acronym
- PrEDDICT-PReV
- Status last verified
- Apr 2019
- First submitted
- 20 Dec 2017
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. doi: 10.1067/mem.2002.122057.
PubMed 11867976Kakuma 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. doi: 10.1046/j.1532-5415.2003.51151.x.
PubMed 12657062Adamis 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. doi: 10.1093/ageing/afm094. Epub 2007 Jul 28.
PubMed 17660528McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern Med. 2002 Feb 25;162(4):457-63. doi: 10.1001/archinte.162.4.457.
PubMed 11863480Lewis 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. doi: 10.1016/0735-6757(95)90080-2.
PubMed 7893295Elie 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.
PubMed 11068569Hustey 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.
PubMed 11015259Monette 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. doi: 10.1016/s0163-8343(00)00116-x.
PubMed 11226553Schuurmans MJ, Duursma SA, Shortridge-Baggett LM. Early recognition of delirium: review of the literature. J Clin Nurs. 2001 Nov;10(6):721-9. doi: 10.1046/j.1365-2702.2001.00548.x.
PubMed 11822843Hustey 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. doi: 10.1067/mem.2003.152.
PubMed 12712035Wilber 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.
PubMed 18691212Han 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.
PubMed 19154565Carpenter 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.
PubMed 21496140Inouye 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. doi: 10.7326/0003-4819-113-12-941.
PubMed 2240918McCusker 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. doi: 10.1111/j.1532-5415.2004.52471.x.
PubMed 15450055
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits (PrEDDICT-PReV) App
- ClinicalTrials.gov ID
- NCT03423875
- Acronym / sponsor ID
- PrEDDICT-PReV / 269-2017
- Conditions
- Delirium
- Keywords
- Delirium, Delirium Recognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,375 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients assigned to the control condition will be treated using the current standard of care, clinical assessments, to identify delirium. |
| Intervention | Experimental | Diagnostic Test: PrEDICT game scorePrEDICTgame 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 65 years of age and older
- Have been in the ED for a minimum of 4 hours at the time of screening
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEDICT game scorePrEDICT game score will be shared with the emergency physicians and health care professionals | Diagnostic test | Intervention |
Primary outcome
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
4 secondary outcomes
Ability of the PrEDICT app to identify patients with incident delirium
Time frame: Between 7-14 days of ED discharge
Ability of the PrEDICT app to identify patients at high risk for incident delirium
Time frame: Between 7-14 days of ED discharge
Unanticipated Barriers to using the PrEDICT app
Time frame: Day 1(ED visit) to Day 4
Feasibility of Tablet Administration by Other Stakeholders
Time frame: Day 1(ED visit) to Day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Background: PubMed 11867976Hustey 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. doi: 10.1067/mem.2002.122057.
- Background: PubMed 12657062Kakuma 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. doi: 10.1046/j.1532-5415.2003.51151.x.
- Background: PubMed 17660528Adamis 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. doi: 10.1093/ageing/afm094. Epub 2007 Jul 28.
- Background: PubMed 11863480McCusker J, Cole M, Abrahamowicz M, Primeau F, Belzile E. Delirium predicts 12-month mortality. Arch Intern Med. 2002 Feb 25;162(4):457-63. doi: 10.1001/archinte.162.4.457.
- Background: PubMed 7893295Lewis 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. doi: 10.1016/0735-6757(95)90080-2.
- Background: PubMed 11068569Elie 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.
- Background: PubMed 11015259Hustey 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.
- Background: PubMed 11226553Monette 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. doi: 10.1016/s0163-8343(00)00116-x.
- Background: PubMed 11822843Schuurmans MJ, Duursma SA, Shortridge-Baggett LM. Early recognition of delirium: review of the literature. J Clin Nurs. 2001 Nov;10(6):721-9. doi: 10.1046/j.1365-2702.2001.00548.x.
- Background: PubMed 12712035Hustey 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. doi: 10.1067/mem.2003.152.
- Background: PubMed 18691212Wilber 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.
- Background: PubMed 19154565Han 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEDICT game score in people with Delirium, run by Sunnybrook Health Sciences Centre at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacques S Lee, MD (416-480-6100 ext. 7701, jacques.lee@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423875, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.