NCT04181775

Brief Summary

The rationale for this study is to evaluate the effectiveness of a risk prediction tool for patients who are at high risk for ADEs resulting in hospitalization or ED revisit. The ADE-RED score initiates a PLMR that literature has shown reduces medication discrepancies and ADEs at hospital admission and discharge. No current system identifies patients presenting to the ED that may benefit from PMLR independent of an admission disposition. The ADE-RED scoring tool will reduce the incidence of future visits to the ED or future admissions by identifying patients who are at high risk for ADE-related readmissions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
471

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 8, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2020

Completed
Last Updated

March 24, 2026

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

November 27, 2019

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidences of ADE-related readmission within 30 days of prior ED visit.

    Incidences of ADE-related readmission within 30 days of prior ED visit.

    one month period in March 2019

Secondary Outcomes (1)

  • Percentage of patients who were readmitted who did or did not have an ADE-RED score at initial ED visit.

    one month period in March 2019

Interventions

ADE-RED scoring toolDIAGNOSTIC_TEST

The ADE-RED scoring tool will reduce the incidence of future visits to the ED or future admissions by identifying patients who are at high risk for ADE-related readmissions.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients are considered high risk if the score is \> 12, moderate risk if the score 6-11, and low risk if the score is 0-5. High-risk patients are flagged in the electronic medical record of the patient, alerting the pharmacist to complete a medication reconciliation and address any issues.

You may qualify if:

  • Patients admitted to the hospital with a prior ED visit within the previous 30 days
  • Patients presenting to the ED with a prior ED visit within the previous 30 days

You may not qualify if:

  • Patients without PTA medications at the time of initial ED presentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Ilka Ratsaphangthong, PharmD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

November 29, 2019

Study Start

November 8, 2019

Primary Completion

June 22, 2020

Study Completion

June 22, 2020

Last Updated

March 24, 2026

Record last verified: 2024-09

Locations