Trial Outcomes & Findings for Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments (NCT NCT06370572)
NCT ID: NCT06370572
Last Updated: 2026-07-23
Results Overview
Measured by numbers of patients
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2421 participants
Primary outcome timeframe
12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED
Results posted on
2026-07-23
Participant Flow
Participant milestones
| Measure |
Post-implementation
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
PAINAD EHR Prompt: Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
|
Pre-implementation
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
|
|---|---|---|
|
Overall Study
STARTED
|
714
|
1707
|
|
Overall Study
COMPLETED
|
714
|
1707
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments
Baseline characteristics by cohort
| Measure |
Pre-implementation
n=1707 Participants
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
|
Post-implementation
n=712 Participants
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
PAINAD EHR Prompt: Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
|
Total
n=2419 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
1707 Participants
n=9 Participants
|
712 Participants
n=27 Participants
|
2419 Participants
n=267 Participants
|
|
Age, Continuous
|
81.5 years
STANDARD_DEVIATION 8.1 • n=9 Participants
|
81.5 years
STANDARD_DEVIATION 8.9 • n=27 Participants
|
81.5 years
STANDARD_DEVIATION 8.3 • n=267 Participants
|
|
Sex: Female, Male
Female
|
1070 Participants
n=9 Participants
|
484 Participants
n=27 Participants
|
1554 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
637 Participants
n=9 Participants
|
228 Participants
n=27 Participants
|
865 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
50 Participants
n=9 Participants
|
33 Participants
n=27 Participants
|
83 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1633 Participants
n=9 Participants
|
669 Participants
n=27 Participants
|
2302 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
34 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
33 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
660 Participants
n=9 Participants
|
424 Participants
n=27 Participants
|
1084 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
960 Participants
n=9 Participants
|
250 Participants
n=27 Participants
|
1210 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
27 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
33 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=9 Participants
|
18 Participants
n=27 Participants
|
50 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
1707 participants
n=9 Participants
|
712 participants
n=27 Participants
|
1269 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the EDMeasured by numbers of patients
Outcome measures
| Measure |
Pre-implementation
n=1707 Participants
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
|
Post-implementation
n=712 Participants
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
PAINAD EHR Prompt: Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
|
|---|---|---|
|
Percentage of Eligible Patients Receiving a PAINAD Assessment Upon ED Arrival
|
568 Participants
|
173 Participants
|
SECONDARY outcome
Timeframe: 12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the EDMeasured by length of time in minutes
Outcome measures
| Measure |
Pre-implementation
n=555 Participants
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
|
Post-implementation
n=606 Participants
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
PAINAD EHR Prompt: Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
|
|---|---|---|
|
Change in Time to Administration of First Analgesic Medication
|
435.9 minutes
Standard Deviation 421.1
|
322.4 minutes
Standard Deviation 340.0
|
SECONDARY outcome
Timeframe: 12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the EDMeasured by PAINAD score; scores range from 0 to 10 (based on a scale of 0 to 2 for five items), with a higher score indicating more severe pain (0="no pain" to 10="severe pain")
Outcome measures
| Measure |
Pre-implementation
n=278 Participants
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
|
Post-implementation
n=88 Participants
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
PAINAD EHR Prompt: Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
|
|---|---|---|
|
Change in Pain Score for Patients Receiving a Repeat PAINAD Assessment
|
-0.35 score on a scale
Standard Deviation 1.85
|
-0.77 score on a scale
Standard Deviation 2.95
|
Adverse Events
Pre-implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post-implementation
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pre-implementation
n=1707 participants at risk
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
|
Post-implementation
n=712 participants at risk
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
PAINAD EHR Prompt: Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
|
|---|---|---|
|
General disorders
Administration of Narcan
|
0.00%
0/1707 • 1 year
|
0.14%
1/712 • Number of events 1 • 1 year
|
|
General disorders
Death
|
0.00%
0/1707 • 1 year
|
0.14%
1/712 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Pre-implementation
n=1707 participants at risk
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
|
Post-implementation
n=712 participants at risk
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
PAINAD EHR Prompt: Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
|
|---|---|---|
|
General disorders
Patient o Zofran
|
0.00%
0/1707 • 1 year
|
0.14%
1/712 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place