Clinical trial NCT06370572: Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments
Official title: Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Hip Pain
Emergency Department Patient
Pain in Advanced Dementia Scale
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of North Carolina, Chapel Hill
First posted: 2024-04-17
Enrollment: 1899
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of eligible patients receiving a PAINAD assessment upon ED arrival
timeFrame: 10 months post-implementation of PAINAD CDS in the ED
Secondary outcomes:
measure: Change in time to administration of first analgesic medication
timeFrame: Baseline (end of 1 year preceding implementation), 10 months
measure: Change in pain score for patients receiving a repeat PAINAD assessment
timeFrame: Baseline (end of 1 year preceding implementation), 10 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of Chicago
name: Teresita M Hogan, MD
role: PRINCIPAL_INVESTIGATOR
References: