Back to resultsAlleviating Geriatric Inpatients' Medication-related Iatrogenesis (AGING)
Primary Purpose
Iatrogenic Disease, Risk Reduction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risk score based intervention
Sponsored by
About this trial
This is an interventional prevention trial for Iatrogenic Disease
Eligibility Criteria
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
Sites / Locations
- Robert Wood Johnson University Hospital SomersetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Standard of Care
Arm Description
Discharge medication regimen instructions will be provided upon discharge after being assessed using the MWRS, optimized, and assessed by the prescriber.
Discharge medication regimen instructions will be provided upon discharge after being assessed by the prescriber.
Outcomes
Primary Outcome Measures
Number of individuals with an emergency department visit or hospital readmission
Number of individuals with an emergency department visit or hospital readmission
Secondary Outcome Measures
Difference in score between patients aged older and younger than 65 years
Comparison between age groups
Full Information
NCT ID
NCT05017948
First Posted
August 17, 2021
Last Updated
August 10, 2023
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT05017948
Brief Title
Alleviating Geriatric Inpatients' Medication-related Iatrogenesis
Acronym
AGING
Official Title
Alleviating Geriatric Inpatients' Medication-related Iatrogenesis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iatrogenic Disease, Risk Reduction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Discharge medication regimen instructions will be provided upon discharge after being assessed using the MWRS, optimized, and assessed by the prescriber.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Discharge medication regimen instructions will be provided upon discharge after being assessed by the prescriber.
Intervention Type
Other
Intervention Name(s)
Risk score based intervention
Intervention Description
Targeted interventions based off of risk score software
Primary Outcome Measure Information:
Title
Number of individuals with an emergency department visit or hospital readmission
Description
Number of individuals with an emergency department visit or hospital readmission
Time Frame
30 days after hospital discharge
Secondary Outcome Measure Information:
Title
Difference in score between patients aged older and younger than 65 years
Description
Comparison between age groups
Time Frame
At time of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Brunetti, PhD
Phone
908-595-2645
Email
luigi.brunetti@rwjbh.org
Facility Information:
Facility Name
Robert Wood Johnson University Hospital Somerset
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Brunetti, PhD
Phone
908-595-2645
Email
luigi.brunetti@rutgers.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Alleviating Geriatric Inpatients' Medication-related Iatrogenesis
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