Trial Outcomes & Findings for Determining the Preliminary Efficacy of the Emergency Department Delirium Screening and Detection Program (NCT NCT05638945)
NCT ID: NCT05638945
Last Updated: 2026-04-21
Results Overview
Delirium detection is defined as the change in the proportion of documented delirium (i.e., the word delirium appears in the chart or there is a positive brief confusion assessment method \[bCAM\]) over time from baseline to 9 months (every 3 months), among patients with delirium. To identify the sample of patients with delirium, trained research staff will use a validated approach to conduct retrospective in-depth chart reviews to assess for ED presence of delirium (sensitivity 74%, specificity 83%) among a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period). Two delirium experts will perform chart checks and adjudicate any uncertain cases. To assess change over time, data will be reported as total charts with positive delirium screens pre ED-DDP (Control Period) and post ED-DDP (Intervention Period).
COMPLETED
NA
3000 participants
Change from baseline to 9 months
2026-04-21
Participant Flow
250 patient charts from each of three participating EDs will be randomly selected every three months during the 15-month stepped-wedge ED-DDP program, with the exception of when an ED is having the program implemented. Thus, chart reviews will take place during Control Period and Implementation Periods only (no patient data is collected during implementation periods). A total of 1,000 patients per site and 3,000 patients overall will be randomly selected throughout the program.
Only charts representing patients aged 65 years or older who presented to a participating ED during control or intervention periods and survived to ED discharge or hospital admission were eligible to be electronically randomized. Each chart was checked again for eligibility after randomization and removed as a protocol violation if eligibility criteria was not confirmed.
Participant milestones
| Measure |
Sequence 1
Sequence 1: 3 months of Control Period, then 3 months of implementation period, followed by 9 months of ED-DDP intervention
|
Sequence 2
Sequence 2: 6 months of Control period, 3 months of Implementation period, then 6 months of Intervention period
|
Sequence 3
Sequence 3: 9 months of Control Period, then 3 months of implementation period, followed by 3 months of ED-DDP intervention
|
|---|---|---|---|
|
Step 1: Months 1-3
STARTED
|
248
|
245
|
244
|
|
Step 1: Months 1-3
COMPLETED
|
248
|
245
|
244
|
|
Step 1: Months 1-3
NOT COMPLETED
|
0
|
0
|
0
|
|
Step 2: Months 4-6
STARTED
|
0
|
238
|
231
|
|
Step 2: Months 4-6
COMPLETED
|
0
|
238
|
231
|
|
Step 2: Months 4-6
NOT COMPLETED
|
0
|
0
|
0
|
|
Step 3: Months 7-9
STARTED
|
250
|
0
|
250
|
|
Step 3: Months 7-9
COMPLETED
|
250
|
0
|
250
|
|
Step 3: Months 7-9
NOT COMPLETED
|
0
|
0
|
0
|
|
Step 4: Months 10-12
STARTED
|
247
|
250
|
0
|
|
Step 4: Months 10-12
COMPLETED
|
247
|
250
|
0
|
|
Step 4: Months 10-12
NOT COMPLETED
|
0
|
0
|
0
|
|
Step 5: Months 13-15
STARTED
|
250
|
247
|
248
|
|
Step 5: Months 13-15
COMPLETED
|
250
|
247
|
248
|
|
Step 5: Months 13-15
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Determining the Preliminary Efficacy of the Emergency Department Delirium Screening and Detection Program
Baseline characteristics by cohort
| Measure |
Control Period
n=1456 Participants
Delirium screening on initial assessment of all older adults presenting to the ED is considered standard of care, but not mandated. All health system EDs have access to a validated EHR integrated delirium screening tool (brief confusion assessment method, or bCAM) and all ED nurses have received training on bCAM use. The bCAM tool is an open parameter in the EHR. For positive bCAM screens, a message is displayed, "This patient has delirium, alert medical team, identify/ treat the underlying cause, ensure patient safety, nonpharmacologic interventions as first line, and avoid physical and chemical restraints". The control period will include chart reviews of patient visits occurring before implementation of the ED-DDP program.
|
Intervention Period
n=1492 Participants
ED leadership at each site have identified 5-10 delirium champions (nurse educators and managers, bedside nurses) based on their interest in delirium and commitment to program participation, including training of nurses by champions. The intervention period will include chart reviews of patient visits occurring after implementation of the ED-DDP program.
|
Total
n=2948 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.5 Years
STANDARD_DEVIATION 8.6 • n=13 Participants
|
78.2 Years
STANDARD_DEVIATION 8.7 • n=13 Participants
|
77.9 Years
STANDARD_DEVIATION 8.7 • n=26 Participants
|
|
Sex: Female, Male
Female
|
844 Participants
n=13 Participants
|
870 Participants
n=13 Participants
|
1714 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
612 Participants
n=13 Participants
|
622 Participants
n=13 Participants
|
1234 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
45 Participants
n=13 Participants
|
87 Participants
n=13 Participants
|
132 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
151 Participants
n=13 Participants
|
131 Participants
n=13 Participants
|
282 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
974 Participants
n=13 Participants
|
884 Participants
n=13 Participants
|
1858 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
237 Participants
n=13 Participants
|
349 Participants
n=13 Participants
|
586 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
49 Participants
n=13 Participants
|
41 Participants
n=13 Participants
|
90 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
229 Participants
n=13 Participants
|
317 Participants
n=13 Participants
|
546 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1176 Participants
n=13 Participants
|
1137 Participants
n=13 Participants
|
2313 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=13 Participants
|
38 Participants
n=13 Participants
|
89 Participants
n=26 Participants
|
|
Charlson Comorbidity Index (CCI)
|
6.8 score on a scale
STANDARD_DEVIATION 3.3 • n=13 Participants
|
6.9 score on a scale
STANDARD_DEVIATION 3.4 • n=13 Participants
|
6.8 score on a scale
STANDARD_DEVIATION 3.3 • n=26 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 9 monthsPopulation: Overall number analyzed represents the total number of documented charts with delirium during each of the control and intervention periods. Only those patient charts with documented delirium were eligible to determine proportion of positive screens. Data is reported per hospital site that received the ED-DDP.
Delirium detection is defined as the change in the proportion of documented delirium (i.e., the word delirium appears in the chart or there is a positive brief confusion assessment method \[bCAM\]) over time from baseline to 9 months (every 3 months), among patients with delirium. To identify the sample of patients with delirium, trained research staff will use a validated approach to conduct retrospective in-depth chart reviews to assess for ED presence of delirium (sensitivity 74%, specificity 83%) among a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period). Two delirium experts will perform chart checks and adjudicate any uncertain cases. To assess change over time, data will be reported as total charts with positive delirium screens pre ED-DDP (Control Period) and post ED-DDP (Intervention Period).
Outcome measures
| Measure |
Control Period
n=192 Participants
Delirium screening on initial assessment of all older adults presenting to the ED is considered standard of care, but not mandated. All health system EDs have access to a validated EHR integrated delirium screening tool (brief confusion assessment method, or bCAM) and all ED nurses have received training on bCAM use. The bCAM tool is an open parameter in the EHR. For positive bCAM screens, a message is displayed, "This patient has delirium, alert medical team, identify/ treat the underlying cause, ensure patient safety, nonpharmacologic interventions as first line, and avoid physical and chemical restraints". The control period will include chart reviews of patient visits occurring before implementation of the ED-DDP program.
|
Intervention Period
n=224 Participants
ED leadership at each site have identified 5-10 delirium champions (nurse educators and managers, bedside nurses) based on their interest in delirium and commitment to program participation, including training of nurses by champions. The intervention period will include chart reviews of patient visits occurring after implementation of the ED-DDP program.
|
|---|---|---|
|
Proportion of Positive Delirium Screens Among Those With Delirium
Hospital Site A
|
0 Participants
|
10 Participants
|
|
Proportion of Positive Delirium Screens Among Those With Delirium
Hospital Site B
|
0 Participants
|
1 Participants
|
|
Proportion of Positive Delirium Screens Among Those With Delirium
Hospital Site C
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to 9 monthsPopulation: Data is reported per hospital site that received the ED-DDP.
Analysis of delirium screening will be defined as proportion of eligible patients screened for delirium using electronic health record (EHR) brief confusion assessment method (bCAM) documentation during their ED visit. Analysis will be conducted on a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period). To assess change over time, data will be reported as total charts of eligible patients who receive delirium screening pre ED-DDP (Control Period) and post ED-DDP (Intervention Period).
Outcome measures
| Measure |
Control Period
n=1456 Participants
Delirium screening on initial assessment of all older adults presenting to the ED is considered standard of care, but not mandated. All health system EDs have access to a validated EHR integrated delirium screening tool (brief confusion assessment method, or bCAM) and all ED nurses have received training on bCAM use. The bCAM tool is an open parameter in the EHR. For positive bCAM screens, a message is displayed, "This patient has delirium, alert medical team, identify/ treat the underlying cause, ensure patient safety, nonpharmacologic interventions as first line, and avoid physical and chemical restraints". The control period will include chart reviews of patient visits occurring before implementation of the ED-DDP program.
|
Intervention Period
n=1492 Participants
ED leadership at each site have identified 5-10 delirium champions (nurse educators and managers, bedside nurses) based on their interest in delirium and commitment to program participation, including training of nurses by champions. The intervention period will include chart reviews of patient visits occurring after implementation of the ED-DDP program.
|
|---|---|---|
|
Proportion of Eligible Patients Who Receive Delirium Screening
Hospital Site B
|
6 Participants
|
9 Participants
|
|
Proportion of Eligible Patients Who Receive Delirium Screening
Hospital Site C
|
67 Participants
|
39 Participants
|
|
Proportion of Eligible Patients Who Receive Delirium Screening
Hospital Site A
|
23 Participants
|
450 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to 9 monthsPopulation: Data is reported per hospital site that received the ED-DDP.
Analysis will be defined as proportion of older adults with any order for safety precautions (fall, aspiration, or wandering) during their ED visit among a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period).To assess change over time, data will be reported as total charts of eligible patients who receive delirium screening pre ED-DDP (Control Period) and post ED-DDP (Intervention Period).
Outcome measures
| Measure |
Control Period
n=1456 Participants
Delirium screening on initial assessment of all older adults presenting to the ED is considered standard of care, but not mandated. All health system EDs have access to a validated EHR integrated delirium screening tool (brief confusion assessment method, or bCAM) and all ED nurses have received training on bCAM use. The bCAM tool is an open parameter in the EHR. For positive bCAM screens, a message is displayed, "This patient has delirium, alert medical team, identify/ treat the underlying cause, ensure patient safety, nonpharmacologic interventions as first line, and avoid physical and chemical restraints". The control period will include chart reviews of patient visits occurring before implementation of the ED-DDP program.
|
Intervention Period
n=1492 Participants
ED leadership at each site have identified 5-10 delirium champions (nurse educators and managers, bedside nurses) based on their interest in delirium and commitment to program participation, including training of nurses by champions. The intervention period will include chart reviews of patient visits occurring after implementation of the ED-DDP program.
|
|---|---|---|
|
Proportion of Eligible Patients Who Receive Safety Precautions
Hospital Site A
|
60 Participants
|
140 Participants
|
|
Proportion of Eligible Patients Who Receive Safety Precautions
Hospital Site B
|
125 Participants
|
131 Participants
|
|
Proportion of Eligible Patients Who Receive Safety Precautions
Hospital Site C
|
194 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to 9 monthsPopulation: Data is reported per hospital site that received the ED-DDP.
Analysis will be defined as proportion of older adults receiving benzodiazepines, antipsychotics, diphenhydramine, or restraints for behavioral symptoms during their ED visit among a randomly sampled population of 3,000 patients (1,000 patients per ED or 250 patients per ED per data collection period). To assess change over time, data will be reported as total charts of eligible patients who receive delirium screening pre ED-DDP (Control Period) and post ED-DDP (Intervention Period).
Outcome measures
| Measure |
Control Period
n=1456 Participants
Delirium screening on initial assessment of all older adults presenting to the ED is considered standard of care, but not mandated. All health system EDs have access to a validated EHR integrated delirium screening tool (brief confusion assessment method, or bCAM) and all ED nurses have received training on bCAM use. The bCAM tool is an open parameter in the EHR. For positive bCAM screens, a message is displayed, "This patient has delirium, alert medical team, identify/ treat the underlying cause, ensure patient safety, nonpharmacologic interventions as first line, and avoid physical and chemical restraints". The control period will include chart reviews of patient visits occurring before implementation of the ED-DDP program.
|
Intervention Period
n=1492 Participants
ED leadership at each site have identified 5-10 delirium champions (nurse educators and managers, bedside nurses) based on their interest in delirium and commitment to program participation, including training of nurses by champions. The intervention period will include chart reviews of patient visits occurring after implementation of the ED-DDP program.
|
|---|---|---|
|
Proportion of Eligible Patients Who Receive Physical and Chemical Restraints for Behavioral Symptoms
Hospital Site B
|
34 Participants
|
32 Participants
|
|
Proportion of Eligible Patients Who Receive Physical and Chemical Restraints for Behavioral Symptoms
Hospital Site C
|
88 Participants
|
29 Participants
|
|
Proportion of Eligible Patients Who Receive Physical and Chemical Restraints for Behavioral Symptoms
Hospital Site A
|
13 Participants
|
46 Participants
|
Adverse Events
Control Period
Intervention Period
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place