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Physician's RoleNCT03666520

Switching Medications From Intravenous to Oral

An observational study of Physician's Role and Administration, Oral, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In a recent report, drug spending increased by 23.4 percent annually in the inpatient setting from 2013 to 2015 with the average inpatient drug spending increasing from $714 to $990 per admission. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Physician's Role, Administration, Oral
What is being tested?
Clinical Decision Support prompted to the clinician to convert drug.
How many people
921 participants
Where
1 siteUnited States
Study dates
1 May 2019to 31 Aug 2019
Phase
Observational
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Inpatient adult patients that are currently being given one of our 8 chosen drugs intravenously.

Who may be able to join

  • Inpatient
  • Over 18
  • Able to tolerate oral medications
  • Currently taking one of our eight medications under research intravenously

Who cannot join

  • Children (<18)
  • Unable to tolerate an oral medication (or NPO)
  • Severe disease severity (Ex. vasopressor dependent, seizures, etc...)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: Inpatient Medications: Switching Medications From Intravenous to Oral

In a recent report, drug spending increased by 23.4 percent annually in the inpatient setting from 2013 to 2015 with the average inpatient drug spending increasing from $714 to $990 per admission. A retrospective analysis from Johns Hopkins showed potential annual savings of over $1,100,000 dollars with a switch from intravenous (IV) to oral (PO) administration of four inpatient medications. Another study actively encouraging the conversion of IV to PO medications demonstrated a decrease in therapeutic costs.

A number of benefits occur at the conversion of IV to oral medications including the reduced risk of secondary cannula- related infections, inflammation, and pain in the area of administration. Most oral agents are less expensive than the related IV medications. Other benefits occur in indirect administration costs such as the expense of nursing labor and equipment. The switch from IV to oral medication has also been shown to result in earlier discharge of patients, potentially saving medical costs.

Read more

The investigators have chosen to further the research of the conversion of IV to PO medications by combining prior knowledge on the subject with robust clinical decision support. Our research will prompt providers at the right time in the workflow to switch from IV to PO medications. The investigators will exclude patients less than 18 years old, with a NPO status, or a severe disease state (vasopressor dependent, decreased consciousness, seizures, severely immunocompromised (ANC < 500), or life- threatening infections such as sepsis, Central Nervous System (CNS) infections, endocarditis, osteomyelitis, etc.). The medications eligible for this research project were identified through comparison of the wholesale price of the intravenous and oral formulations. To select medications with a potential for savings, the investigators factored in the frequency of IV administrations in the past five months using our electronic health record system (EHR) to help identify highly utilized medications. The product of the largest cost differential and frequency was used to decide on the following list of medications for this project: Lacosamide, Doxycycline, Levothyroxine, Linezolid, Acetaminophen, Rifampin, Amiodarone and Levofloxacin.

The principal trigger for the clinical decision support prompt will be a current diet order listed in the patient's chart or an order for another medication via the oral route. These orders will flag the patient as eligible for po medications. Once the patient has been identified to be eligible for PO medications, the presence of an order for an IV formulation of one of the above drugs will prompt a once-daily alert to the provider upon opening the chart for the conversion to PO medication. Providers will be randomized to receive the alert. Past experience has shown that such an alert will remind providers not only to switch the drug in questions to PO form, but other medications as well. For the providers not receiving the alert, the investigators will record when it would have been triggered for the first time. The trial will run for three months to completion.

Analysis at the time of study completion will occur on primary (number of doses of candidate medication administered IV and PO after the alert) and secondary outcomes (number of doses of other medication not on our IV and PO list, cost savings, presence of an iv drip, episodes of sepsis or bacteremia). The investigators will monitor for potential complications by monitoring length of stay after triggering the alert. The investigators will also monitor the doses of hyaluronidase administered to patients after the alert was triggered.

Being tested
Clinical Decision Support prompted to the clinician to convert drug.
Keywords
medication administration, IV to PO conversion, IV to PO conversion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Decision Support prompted to the clinician to convert drug.Other

    This study is designed to further research the conversion of Intravenous medications to oral medications in patients in an inpatient setting whenever it is appropriate and safe. We have chosen eight medications to research in this study. These medications were chosen because large difference in cost between an intravenous (IV) dose of this medication versus an oral (PO) dose of this medication exist. This study aims to further evaluate the appropriateness and safety of converting IV medications to PO medications for hospitalized patients through a pilot clinical trial.

Study groups in NCT03666520
Study groupRoleWhat they receive
Control GroupClinician not prompted to change the drug from intravenous to oral equivalent.
Cohort with clinician being prompted to convert drugThis arm would include the provider being prompted to change the intravenous drug to the oral equivalent.
Receives: Other: Clinical Decision Support prompted to the clinician to convert drug.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication change from intravenous to oral

    Number of doses of candidate medication administered intravenous and oral after the alert

    Measured: Change from Baseline to 4 months

Secondary outcomes (1)
  1. Doses of other medications

    Number of doses of other medication not on our intravenous and oral list

    Measured: Change from Baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start1 May 2019
  3. Primary completion31 Aug 2019
  4. Study completion31 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
921 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03666520
Sponsor's protocol ID
023420
Status last verified
Oct 2019
First submitted
29 Aug 2018
Last updated
8 Oct 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Physician's Role and Administration, Oral, run by Vanderbilt University Medical Center 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Oct 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication change from intravenous to oral (time frame: Change from Baseline to 4 months). 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 8 Oct 2019.

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