Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

Dementia Clinical Trial

Official title:

Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370572
• Other study ID #: CIRB23-1162
• Secondary ID: U54AG063546
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1899
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Emergencies
• Hip Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Aging (NIA), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of eligible patients receiving a PAINAD assessment upon ED arrival	Measured by numbers of patients	10 months post-implementation of PAINAD CDS in the ED
Secondary	Change in time to administration of first analgesic medication	Measured by length of time in minutes	Baseline (end of 1 year preceding implementation), 10 months
Secondary	Change in pain score for patients receiving a repeat PAINAD assessment	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")	Baseline (end of 1 year preceding implementation), 10 months