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Completed

NCT Number: NCT06370572

Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAINAD EHR Prompt

Other

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

Primary outcomes

  1. Percentage of Eligible Patients Receiving a PAINAD Assessment Upon ED Arrival

    Time frame: 12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED

    Measured by numbers of patients

Secondary outcomes

  1. Change in Time to Administration of First Analgesic Medication

    Time frame: 12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED

    Measured by length of time in minutes

  2. Change in Pain Score for Patients Receiving a Repeat PAINAD Assessment

    Time frame: 12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED

    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")

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute on Aging (NIA)
  • University of North Carolina, Chapel Hill

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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