IV Ensure in Patients Receiving OPAT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-23

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Determine adherence rate for IV medications administered in the home.

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.

Group Type EXPERIMENTAL

Remote therapeutic monitoring device

Intervention Type 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.

Assess re-admission against adherence rates.

Assess correlation of patients hospital re-admission rates for infection related disease progression associated with adherence rates of IV medications administered in the home.

Group Type EXPERIMENTAL

Remote therapeutic monitoring device

Intervention Type 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.

Interventions

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Remote 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.

Intervention Type DEVICE

Other Intervention Names

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IV Advocate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No