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Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06370572
Enrollment
2421
Registered
2024-04-17
Start date
2024-08-19
Completion date
2025-09-30
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Emergency Department Patient, Hip Pain, Pain in Advanced Dementia Scale

Brief summary

The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff will enable them to accurately assess pain levels and lead to better pain treatment for PLWD.

Detailed description

This is a pragmatic pilot for a Stage IV effectiveness, embedded pragmatic clinical trial (ePCT) studying the feasibility of PAINAD assessment implementation via simple EHR prompts for PLWD presenting to the ED with hip pain at the University of Chicago Medicine (UCM) and the University of North Carolina at Chapel Hill (UNC-CH). Identification of subjects with hip pain and dementia contains the level of specificity needed for a pragmatic trial, and occurs on ED arrival, prompting an electronic health record clinical decision support (CDS). The Pain in Advance Dementia (PAINAD) Score is a behavioral score based on observation of the person. The score depends on observation of five behaviors, breathing, negative vocalizations, facial expressions, body language, and consolability. Each observed behavior is scored from zero = none, to two = most, for a total score from zero to ten. The design is an interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale. Pre-intervention data from most immediate year to date prior to the intervention start defines the baseline state. The intervention, the EHR prompt to document the PAINAD first on patient arrival to the ED treatment area, and second one hour after delivery of first pain treatment. Prospective evaluation of EHR data will be used to evaluate use of the PAINAD.

Interventions

OTHERPAINAD EHR Prompt

Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain

Sponsors

University of Chicago
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
University of North Carolina, Chapel Hill
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients greater than or equal to 65 years old * ED arrival complaint of hip pain * History of dementia by past medical history or problem list in EHR

Exclusion criteria

* Patients do not meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Eligible Patients Receiving a PAINAD Assessment Upon ED Arrival12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the EDMeasured by numbers of patients

Secondary

MeasureTime frameDescription
Change in Time to Administration of First Analgesic Medication12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the EDMeasured by length of time in minutes
Change in Pain Score for Patients Receiving a Repeat PAINAD Assessment12 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")

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORTeresita M Hogan, MD

University of Chicago

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
2419 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous81.5 years
STANDARD_DEVIATION 8.1
Ethnicity (NIH/OMB)
Hispanic or Latino
50 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
669 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
34 Participants
Race (NIH/OMB)
American Indian or Alaska Native
8 Participants
Race (NIH/OMB)
Asian
10 Participants
Race (NIH/OMB)
Black or African American
424 Participants
Race (NIH/OMB)
More than one race
33 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
18 Participants
Race (NIH/OMB)
White
1210 Participants
Region of Enrollment
United States
712 participants
Sex: Female, Male
Female
1554 Participants
Sex: Female, Male
Male
637 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1,7071 / 712
other
Total, other adverse events
0 / 1,7071 / 712
serious
Total, serious adverse events
0 / 1,7072 / 712

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026