Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

Not Applicable

Recruiting

• Conditions: Dementia; Hip Pain; Emergency Department Patient; Pain in Advanced Dementia Scale
• Interventions: Other: PAINAD EHR Prompt

• Registration Number: NCT06370572
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Study Start: 2024-08-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1899

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Post-implementation	PAINAD EHR Prompt	PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt

Primary Outcome Measures

Name	Time	Method
Percentage of eligible patients receiving a PAINAD assessment upon ED arrival	10 months post-implementation of PAINAD CDS in the ED	Measured by numbers of patients

Secondary Outcome Measures

Name	Time	Method
Change in pain score for patients receiving a repeat PAINAD assessment	Baseline (end of 1 year preceding implementation), 10 months	Measured 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")
Change in time to administration of first analgesic medication	Baseline (end of 1 year preceding implementation), 10 months	Measured by length of time in minutes

Trial Locations

Locations (2)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States