IV Ensure in Patients Receiving OPAT

Not Applicable

Recruiting

• Conditions: Determine If Adherence Rates with IV Antibiotics in OPAT Have a Correlation to Hospital Readmission Rates
• Interventions: Device: Remote therapeutic monitoring device

• Registration Number: NCT06623318
• Lead Sponsor: IV Ensure

Brief Summary

The purpose of remote therapeutic monitoring is to provide oversight and evaluation of patients receiving IV medications in the home setting post-acute. The goal is to improve patient outcomes and decrease re-admission rates for related diagnoses due to poor adherence. Remote therapeutic monitoring provides data used in the determination of dates, times, and duration of doses administered in the home setting to support real-time intervention by dedicated care managers to support improved adherence with prescribed dosing regiments. The objectives of the study are to:

1. Determine adherence rates for IV medications administered in the home.

2. Assess re-admission against adherence rates.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-23
• Status Verified: 2024-09
• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2024-10-15
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Adult patients enrolled in OPAT (IV antibiotic therapy) discharged to the home setting will be included in the study.

Exclusion Criteria

• Patients enrolled in OPAT (IV antibiotic therapy) discharged to nursing homes, SNF (Skilled Nursing Facility), and pediatric patients will be excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Determine adherence rate for IV medications administered in the home.	Remote therapeutic monitoring device	Patients will be assigned IV Ensure's remote therapeutic monitoring device to determine their adherence rate with administration of IV medications administered in the home in comparison to their provider's orders.
Assess re-admission against adherence rates.	Remote therapeutic monitoring device	Assess correlation of patients hospital re-admission rates for infection related disease progression associated with adherence rates of IV medications administered in the home.

Primary Outcome Measures

Name	Time	Method
Readmission due to subsequent related infection following the initial encounter.	From enrollment to 30 days after completion of prescribed IV medication.	This will be defined as a dichotomous outcome variable with Yes occurring when (a) a patients ID reoccurs in the OU Medicine EMR/EHR data pull within 30 days of their discharge with IV Ensure remote therapeutic monitoring device and (b) the patients readmissions reason matched the pre-specified list of ICD codes corresponding to secondary or downstream infections. If both of the above do not occur, the readmission variable will be set to No.

Trial Locations

Locations (1)

The University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States