Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

NCT ID: NCT06370572

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

714 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-19

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Dementia Hip Pain Emergency Department Patient Pain in Advanced Dementia Scale

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-implementation

PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-implementation

PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt

Group Type EXPERIMENTAL

PAINAD EHR Prompt

Intervention Type OTHER

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

Interventions

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PAINAD EHR Prompt

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teresita M Hogan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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U54AG063546

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CIRB23-1162

Identifier Type: -

Identifier Source: org_study_id

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