Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

Last updated: June 5, 2025
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Treatment

PAINAD EHR Prompt

Clinical Study ID

NCT06370572
CIRB23-1162
U54AG063546
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients do not meet inclusion criteria

Study Design

Total Participants: 1899
Treatment Group(s): 1
Primary Treatment: PAINAD EHR Prompt
Phase:
Study Start date:
August 19, 2024
Estimated Completion Date:
February 01, 2026

Study 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.

Connect with a study center

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.