IV Ensure in Patients Receiving OPAT

September 30, 2024 updated by: IV Ensure

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • The University of Oklahoma Health Sciences Center
        • Contact:
        • Contact:
        • Contact:
          • Joseph Sassine, MD, FACP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Other Names:
  • IV Advocate
Experimental: 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.
Device: 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.
Other Names:
  • IV Advocate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission due to subsequent related infection following the initial encounter.
Time Frame: 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.
From enrollment to 30 days after completion of prescribed IV medication.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IV Ensure

Collaborators

University of Oklahoma

Investigators

  • Principal Investigator: Joseph Sassine, MD, FACP, The University of Oklahoma Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

October 15, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IVEnsure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The participant information will not be used or distributed for future research studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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