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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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