Determine If Adherence Rates with IV Antibiotics in OPAT Have a Correlation to Hospital Readmission RatesNCT06623318
IV Ensure in Patients Receiving OPAT
A study testing Remote therapeutic monitoring device in people with Determine If Adherence Rates with IV Antibiotics in OPAT Have a Correlation to Hospital Readmission Rates, run by IV Ensure at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Determine If Adherence Rates with IV Antibiotics in OPAT Have a Correlation to Hospital Readmission Rates
- What is being tested?
- Remote therapeutic monitoring device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients enrolled in OPAT (IV antibiotic therapy) discharged to the home setting will be included in the study.
Who cannot join
- Patients enrolled in OPAT (IV antibiotic therapy) discharged to nursing homes, SNF (Skilled Nursing Facility), and pediatric patients will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Joseph Sassine, MD, FACP, 405-271-6122, joseph-sassine@ouhsc.edu
Brittany Karfonta, 405-271-3480, Brittany-Karfonta@ouhsc.edu
About this study
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:
- Determine adherence rates for IV medications administered in the home.
- Assess re-admission against adherence rates.
- Being tested
- Remote therapeutic monitoring device
- Keywords
- OPAT, IV antibiotic, Adherence, home infusion, readmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote therapeutic monitoring deviceDevice
Also called IV Advocate
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.
| Study group | Role | What they receive |
|---|---|---|
| Determine adherence rate for IV medications administered in the home. | Experimental | 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. Receives: Device: Remote therapeutic monitoring device |
| Assess re-admission against adherence rates. | Experimental | Assess correlation of patients hospital re-admission rates for infection related disease progression associated with adherence rates of IV medications administered in the home. Receives: Device: Remote therapeutic monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission due to subsequent related infection following the initial encounter.
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.
Measured: From enrollment to 30 days after completion of prescribed IV medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start23 Aug 2023
- Primary completion15 Oct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determine If Adherence Rates with IV Antibiotics in OPAT Have a Correlation to Hospital Readmission RatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IV Ensure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oklahoma
- Responsible party
- Sponsor
- Investigators
- Joseph Sassine, MD, FACP, Principal investigator, The University of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623318
- Sponsor's protocol ID
- IVEnsure
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The participant information will not be used or distributed for future research studies.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV Ensure in Patients Receiving OPAT
- ClinicalTrials.gov ID
- NCT06623318
- Acronym / sponsor ID
- IVEnsure
- Keywords
- OPAT, IV antibiotic, Adherence, home infusion, readmission
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- IV EnsureIndustry (pharma, biotech, devices)
- Collaborators
- University of Oklahoma
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Determine adherence rates for IV medications administered in the home.
- Assess re-admission against adherence rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Determine adherence rate for IV medications administered in the home. | Experimental | Device: Remote therapeutic monitoring devicePatients 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. |
| Assess re-admission against adherence rates. | Experimental | Device: Remote therapeutic monitoring deviceAssess correlation of patients hospital re-admission rates for infection related disease progression associated with adherence rates of IV medications administered in the home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients enrolled in OPAT (IV antibiotic therapy) discharged to the home setting will be included in the study.
Key exclusion criteria (1 listed)
- Patients enrolled in OPAT (IV antibiotic therapy) discharged to nursing homes, SNF (Skilled Nursing Facility), and pediatric patients will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote therapeutic monitoring deviceAlso: IV AdvocateIV 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. | Device | Assess re-admission against adherence rates., Determine adherence rate for IV medications administered in the home. |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No. The participant information will not be used or distributed for future research studies.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Sassine, MD, FACP principal investigator
The University of Oklahoma Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote therapeutic monitoring device in people with Determine If Adherence Rates with IV Antibiotics in OPAT Have a Correlation to Hospital Readmission Rates, run by IV Ensure at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitchell T Berenson, MPH (214-924-6951, mitchell@ivensure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.