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

Primary Purpose

Delirium

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PrEDICT game score
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Delirium focused on measuring Delirium, Delirium Recognition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nova Scotia Health AuthorityRecruiting
  • Ottawa Hospital Research InstituteRecruiting
  • Sunnybrook Research InstituteRecruiting
  • CHU de Québec - Université LavalRecruiting
  • Alberta Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Patients assigned to the control condition will be treated using the current standard of care, clinical assessments, to identify delirium.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.
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.

Full Information

First Posted
December 20, 2017
Last Updated
April 8, 2019
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03423875
Brief Title
Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits
Acronym
PrEDDICT-PReV
Official Title
Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits (PrEDDICT-PReV) App
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Delirium Recognition

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
1375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients assigned to the control condition will be treated using the current standard of care, clinical assessments, to identify delirium.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
PrEDICT game score
Intervention Description
PrEDICT game score will be shared with the emergency physicians and health care professionals
Primary Outcome Measure Information:
Title
Delirium recognition by ED staff
Description
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
Time Frame
Delirium recognition by ED staff will be measured during their index ED visit, within 4 hours of assessment using the PrEDICT app.
Secondary Outcome Measure Information:
Title
Ability of the PrEDICT app to identify patients with incident delirium
Description
Our Secondary outcome will be to correlate the PrEDICT game score with patients who develop incident delirium as assessed using the CAM
Time Frame
Between 7-14 days of ED discharge
Title
Ability of the PrEDICT app to identify patients at high risk for incident delirium
Description
Our Secondary outcome will be to correlate the PrEDICT game score with patients who develop incident delirium as assessed using delirium index
Time Frame
Between 7-14 days of ED discharge
Title
Unanticipated Barriers to using the PrEDICT app
Description
Clinical feasibility will be assessed as the proportion of eligible patients that are able to complete use of the PrEDICT serious game.
Time Frame
Day 1(ED visit) to Day 4
Title
Feasibility of Tablet Administration by Other Stakeholders
Description
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.
Time Frame
Day 1(ED visit) to Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques S Lee, MD
Phone
416-480-6100
Ext
7701
Email
jacques.lee@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Yeung, HBSc
Phone
416-480-6100
Ext
7702
Email
joanna.yeung@sunnybrook.ca
Facility Information:
Facility Name
Nova Scotia Health Authority
City
Nova Scotia
State/Province
Halifax
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judah Goldstein
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Clement
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Yeung
Facility Name
CHU de Québec - Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Boucher
Facility Name
Alberta Health Services
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hina Walia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11867976
Citation
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Results Reference
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PubMed Identifier
12657062
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. doi: 10.1046/j.1532-5415.2003.51151.x.
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PubMed Identifier
17660528
Citation
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PubMed Identifier
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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. doi: 10.1001/archinte.162.4.457.
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Predicting Emergency Department Delirium With an Interactive Customizable Tablet to Prevent Repeat Visits

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