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IV Ensure in Patients Receiving OPAT

IV Ensure in Patients Receiving OPAT

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06623318
Enrollment
90
Registered
2024-10-02
Start date
2023-08-23
Completion date
2024-11-30
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Determine If Adherence Rates with IV Antibiotics in OPAT Have a Correlation to Hospital Readmission Rates

Keywords

OPAT, IV antibiotic, Adherence, home infusion, readmission

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.

Interventions

DEVICERemote therapeutic monitoring device

IV Ensure proprietary remote therapeutic monitoring device is used to record and transmit data associated with date, time, and duration of IV medications administered in the home setting post-acute.

Sponsors

University of Oklahoma
CollaboratorOTHER
IV Ensure
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The investigation will be designed as a retrospective cohort study, in which assignment to the IV Ensure device is determined based on patient discharge status (home IV for antimicrobial therapy) and current device allocation. Patients will be assigned to IV Ensure subsequent to their initial health encounter for their admitting diagnosis. The non-treatment group will be assigned to home infusion therapy using the current standard of care of OU Medicine. This group is required in order to assess whether the usage of the IV Ensure device is associated with a reduction in subsequent readmission risk due to infection.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

United States

Contacts

Primary ContactMitchell T Berenson, MPH
mitchell@ivensure.com214-924-6951
Backup ContactJacob K Dozier, BGS
jacob.dozier@ivensure.com903-244-4842

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026