NCT06370572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
714

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 9, 2026

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

April 12, 2024

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change in time to administration of first analgesic medication

    Baseline (end of 1 year preceding implementation), 10 months

  • Change in pain score for patients receiving a repeat PAINAD assessment

    Baseline (end of 1 year preceding implementation), 10 months

Study Arms (2)

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

Other: PAINAD EHR Prompt

Interventions

Implementation of PAINAD EHR prompt in the ED workflow for PLWD presenting to the ED with hip pain

Post-implementation

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Teresita M Hogan, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 17, 2024

Study Start

August 19, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

January 9, 2026

Record last verified: 2025-06

Locations