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| ID | Type | Description | Link |
|---|---|---|---|
| U54AG063546 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| University of North Carolina, Chapel Hill | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-implementation | No Intervention | PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt | |
| Post-implementation | Experimental | PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAINAD EHR Prompt | Other | Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in pain score for patients receiving a repeat PAINAD assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teresita M Hogan, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| University of North Carolina at Chapel Hill |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2026 | |
| Unrelease | May 26, 2026 | |
| Release | May 26, 2026 | |
| Reset | Jun 22, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2026 | May 26, 2026 | |||
| May 26, 2026 |
| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale.
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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")
| Baseline (end of 1 year preceding implementation), 10 months |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Jun 22, 2026 |
| Jun 25, 2026 |
| D001523 | Mental Disorders |