IV Ensure in Patients Receiving OPAT

Purpose

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.

Condition

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
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.
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Joseph Sassine, MD, FACP
405-271-6122
joseph-sassine@ouhsc.edu

More Details

Status
Recruiting
Sponsor
IV Ensure

Study Contact

Mitchell T Berenson, MPH
214-924-6951
mitchell@ivensure.com