Alleviating Geriatric Inpatients' Medication-related Iatrogenesis

NCT05017948 | Completed

• 1 other identifier: Pro2021001087
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iatrogenic Disease; Risk Reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference in score between patients aged older and younger than 65 years

  At time of intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Discharge medication regimen instructions will be provided upon discharge after being assessed by the prescriber.

Interventions

Risk score based intervention OTHER

Targeted interventions based off of risk score software

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876, United States

Location

MeSH Terms

Conditions

Iatrogenic Disease; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: September 15, 2021
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 9 months and ending 36 months following article publication.
• 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.

Locations

US (1)