Clinical Trials Directory

Trials / Completed

CompletedNCT06370572

Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
714 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPAINAD EHR PromptImplementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain

Timeline

Start date
2024-08-19
Primary completion
2025-09-30
Completion
2025-09-30
First posted
2024-04-17
Last updated
2026-01-09

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT06370572. Inclusion in this directory is not an endorsement.