Alleviating Geriatric Inpatients' Medication-related Iatrogenesis (AGING)

This study will evaluate the MedWise Risk Score™ (MWRS™), a holistic approach to quantifying the risk of a patient's medication regimen. High risk patients will be identified at hospital discharge. Targeted interventions will be made to reduce their MWRS™ with a 30-day follow up. The hypothesis being tested is that a reduction in MWRS™ will lead to reduced 30-day readmission.

Study Overview

• Status: Completed
• Conditions: Iatrogenic Disease; Risk Reduction
• Intervention / Treatment: Other: Risk score based intervention

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Somerville, New Jersey, United States, 08876
      • Robert Wood Johnson University Hospital Somerset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospital admission for at least 48 hours
• Prescribed at least 5 medications at hospital discharge
• Baseline medication risk score of 20 or more

Exclusion Criteria:

• Reside greater than 25 miles from the index facility
• Discharge to hospice
• Discharge against medical advice
• Patient expiration during initial hospitalization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Discharge medication regimen instructions will be provided upon discharge after being assessed using the MWRS, optimized, and assessed by the prescriber.	Other: Risk score based intervention; Targeted interventions based off of risk score software
No Intervention: Standard of Care; Discharge medication regimen instructions will be provided upon discharge after being assessed by the prescriber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of individuals with an emergency department visit or hospital readmission	Number of individuals with an emergency department visit or hospital readmission	30 days after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in score between patients aged older and younger than 65 years	Comparison between age groups	At time of intervention

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease
• Other Study ID Numbers: Pro2021001087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results in publications, after deidentification (text, tables, figures, and appendices) will be shared.
• IPD Sharing Time Frame: Data will be available beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Data will be shared with investigators whose proposed use of the data has been approved. Proposals should be directed to brunetti@rutgers.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No