DementiaNCT06370572
Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments
A study testing PAINAD EHR Prompt in people with Dementia and Hip Pain, run by University of Chicago at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Hip Pain, Emergency Department Patient
- What is being tested?
- PAINAD EHR Prompt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,421 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Aug 2024to 30 Sep 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Patients do not meet inclusion criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Chicago
Chicago, Illinois, 60637
About this study
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.
Read the 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.
- Being tested
- PAINAD EHR Prompt
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAINAD EHR PromptOther
Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: PAINAD EHR Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Patients Receiving a PAINAD Assessment Upon ED Arrival
Measured by numbers of patients
Measured: 12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED
Secondary outcomes (2)
Change in Time to Administration of First Analgesic Medication
Measured by length of time in minutes
Measured: 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
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")
Measured: 12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start19 Aug 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale.
- Masking
- None (open label)
- Enrolment
- 2,421 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Teresita M Hogan, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370572
- Sponsor's protocol ID
- CIRB23-1162
- Other IDs
- U54AG063546
- Status last verified
- May 2026
- First submitted
- 12 Apr 2024
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No