Recruiting

Ensure

Sponsor:

IV Ensure

Code:

NCT06623318

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Remote therapeutic monitoring device

Study Details

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.

Conditions

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

Study ID

NCT06623318

Start date

Aug 23, 2023

Status verified date

Sep, 2024

Completion date

Nov, 2024

Anticipated

Primary completion date

Oct 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mitchell T Berenson, MPH

214-924-6951mitchell@ivensure.com

Jacob K Dozier, BGS

903-244-4842jacob.dozier@ivensure.com

Locations

The University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Joseph Sassine, MD, FACP

405-271-6122joseph-sassine@ouhsc.edu

Brittany Karfonta

405-271-3480Brittany-Karfonta@ouhsc.edu

More Information

Sponsor

IV Ensure

Last update posted

Oct 2, 2024

Last verified

Sep, 2024

Keywords

  • OPAT
  • IV antibiotic
  • Adherence
  • home infusion
  • readmission

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IV Ensure on 2024-10-02.