Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 2,421
- Locations
- 2
- Primary Endpoint
- Percentage of eligible patients receiving a PAINAD assessment upon ED arrival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Pre-implementation
PLWD presenting to the ED with reported hip pain in the year preceding implementation of the PAINAD EHR prompt
Post-implementation
PLWD presenting to the ED with reported hip pain in the 10 months following implementation of the PAINAD EHR prompt
Intervention: PAINAD EHR Prompt (Other)
Outcomes
Primary Outcomes
Percentage of eligible patients receiving a PAINAD assessment upon ED arrival
Time Frame: 10 months post-implementation of PAINAD CDS in the ED
Measured by numbers of patients
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
Measured by numbers of patients
Secondary Outcomes
- Change in pain score for patients receiving a repeat PAINAD assessment(Baseline (end of 1 year preceding implementation), 10 months)
- Change in time to administration of first analgesic medication(Baseline (end of 1 year preceding implementation), 10 months)
- Change in Time to Administration of First Analgesic Medication(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(12 months pre-implemenation and 10 months post-implementation of PAINAD CDS in the ED)