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.
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.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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.
- Conditions
- Physician's Role, Administration, Oral
- 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 group | Role | What they receive |
|---|---|---|
| Control Group | Clinician not prompted to change the drug from intravenous to oral equivalent. | |
| Cohort with clinician being prompted to convert drug | This 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.
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)
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.
- First posted11 Sep 2018
- Study start1 May 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician's RoleStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Turer, Vanderbilt University Medical Center
- Investigators
- Christoph Lehmann, MD, Study director, Vanderbilt University Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Medications: Switching Medications From Intravenous to Oral
- ClinicalTrials.gov ID
- NCT03666520
- Acronym / sponsor ID
- 023420
- Conditions
- Physician's Role, Administration, Oral
- Keywords
- medication administration, IV to PO conversion, IV to PO conversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 11 Sep 2018 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Clinician not prompted to change the drug from intravenous to oral equivalent. |
| Cohort with clinician being prompted to convert drug | – | Other: Clinical Decision Support prompted to the clinician to convert drug.This arm would include the provider being prompted to change the intravenous drug to the oral equivalent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient adult patients that are currently being given one of our 8 chosen drugs intravenously.
Key inclusion criteria (4 listed)
- Inpatient
- Over 18
- Able to tolerate oral medications
- Currently taking one of our eight medications under research intravenously
Key exclusion criteria (3 listed)
- Children (<18)
- Unable to tolerate an oral medication (or NPO)
- Severe disease severity (Ex. vasopressor dependent, seizures, etc...)
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 |
|---|---|---|
| Clinical Decision Support prompted to the clinician to convert drug.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. | Other | Cohort with clinician being prompted to convert drug |
Primary outcome
Medication change from intravenous to oral
Time frame: Change from Baseline to 4 months
Number of doses of candidate medication administered intravenous and oral after the alert
1 secondary outcome
Doses of other medications
Time frame: Change from Baseline to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
Christoph Lehmann, MD study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
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.