Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre-implementation
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
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|
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Experimental: Post-implementation
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
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Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Measured by numbers of patients
|
12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED
|
|
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
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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")
|
12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Teresita M Hogan, MD, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRB23-1162
- U54AG063546 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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