InfectionsNCT05471726
Improving Post-discharge Antimicrobial Use
A study testing Prospective audit-and-feedback in people with Infections, run by Iowa City Veterans Affairs Medical Center at 5 sites in United States.
Trial summary
One in five hospitalized patients is prescribed an antimicrobial at the time of discharge, and a large proportion of these post-discharge antimicrobials are unnecessary. The investigators will evaluate a novel method for reviewing post-discharge antimicrobial prescriptions in real-time with the goal of improving… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infections
- What is being tested?
- Prospective audit-and-feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 May 2023to 9 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- --The local stewardship team agrees to implement the discharge stewardship intervention on at least one inpatient service or ward.
Who cannot join
- --The hospital already has an audit-and-feedback process in place that focuses on antimicrobial prescribing at hospital discharge.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Baltimore VA Medical Center
Baltimore, Maryland, 21201-1524
Richard Roudebush VA Medical Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Audie L Murphy VA Medical Center
San Antonio, Texas, 78229
Barnes Jewish Hospital and affiliated hospitals
St Louis, Missouri, 63110
About this study
Official title: Improving Post-discharge Antimicrobial Use: a Multicenter Stepped Wedge Trial Study
One in five hospitalized patients is prescribed an antimicrobial at the time of discharge, and a large proportion of these post-discharge antimicrobials are unnecessary. The investigators will evaluate a novel method for reviewing post-discharge antimicrobial prescriptions in real-time with the goal of improving antimicrobial selection and duration.
Read the detailed description
Antimicrobial stewardship programs (ASPs) work to improve antibiotic prescribing within hospitals. ASPs often restrict their activities to inpatient antimicrobial-prescribing. However, at least 40% of all antimicrobial exposure associated with an acute-care hospital stay is prescribed at the time of hospital discharge (i.e., post-discharge). Post-discharge antimicrobials mediate clinical outcomes after discharge and may facilitate the spread of antimicrobial resistance.
Several studies have shown that post-discharge antimicrobial use is often inappropriate. For example, using national VA data, the investigators found that 61% of fluoroquinolone treatment days were prescribed at hospital discharge; manual chart reviews at 9 hospitals found that 40% of these post-discharge fluoroquinolone prescriptions were either unnecessary or sub-optimal. Other studies have found that 53-79% of all post-discharge antimicrobials are either unnecessary or sub-optimal.
Post-discharge antimicrobials are an important target for antimicrobial stewardship. However, inpatient stewardship metrics do not capture post-discharge antimicrobials and ASPs frequently do not evaluate these prescriptions. A 2016 VA survey found that less than 50% of hospitals routinely reviewed targeted antimicrobials at discharge. According to a 2016 survey in Michigan, only 17% of 48 hospitals had a process for reviewing outpatient antimicrobial orders at discharge.
It is unclear how inpatient stewardship resources can be effectively leveraged to improve post-discharge antimicrobial use. If the goal is to improve post-discharge antimicrobial use, a potentially effective strategy may be an audit-and-feedback process focused solely on prescriptions for patients who will soon be discharged. In this trial, the investigators will evaluate the feasibility and effectiveness of such a process.
- Conditions
- Infections
- Being tested
- Prospective audit-and-feedback
- Keywords
- antibiotic prescriptions, hospital discharge, antibiotic stewardship
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective audit-and-feedbackBehavioural
The stewardship team will review patients who are on antibiotics, have an uncomplicated infection, and are eligible to continue antibiotics after discharge. Any recommendations from the stewardship team about optimizing antibiotic therapy will be presented to the primary prescriber in real-time with the goal of improving antibiotic selection and duration at hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Prospective audit-and-feedback at discharge | Experimental | When hospitals are in the intervention arm, they will perform the audit-and-feedback process focused on patients receiving antimicrobials who have an anticipated discharge. Receives: Behavioral: Prospective audit-and-feedback |
| Standard of care | No intervention | When hospitals are in the control arm, they will not perform a stewardship process that focuses on hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-discharge antibiotic length of therapy
The primary outcome will be post-discharge antimicrobial length of therapy (LOT) per 100 admissions. The investigators will calculate this by adding post-discharge LOT across all patients on the participating services and dividing by the number of patient-admissions discharged from those services during the study period.
Measured: Every 2-week-period through study completion (48 weeks total)
Secondary outcomes (2)
Inpatient antibiotic length of therapy
Inpatient antibiotic LOT will be calculated by adding inpatient LOT across all patients on the participating services and dividing by the number of patient-admissions discharged from those services during the study period.
Measured: Every two-week period through study completion (48 weeks total)
Percentage of participants with hospital readmission
Hospital readmissions reflect the need for (re) admission to an acute-care bed at a participating facility for any indication within 30 days of the patient's discharge.
Measured: 30 days from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start22 May 2023
- Primary completion19 Nov 2023
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa City Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471726
- Sponsor's protocol ID
- IRB 202109288
- Status last verified
- Oct 2024
- First submitted
- 13 Jul 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be aggregated to the hospital-level without including patient identifiers. This is a requirement for transmitting data across the institutions participating in this trial.
Publications
Livorsi DJ, Thompson AM, Green MS, Hoelscher AC, Chu KK, Neuner E, Burnett Y, Hopkins T, Walter E, Dave R, Tripathi R, Lohmar H, Dysangco A, Percival K, Ince D, Kolkmeyer J, Newland H, Hendrix MJ, Clore G, Poe C, O'Shea A, Tholany J, Prasidthrathsint K, Rachmiel E, Bongu J, Bewley A, Hsueh K. Prospective Audit and Feedback by Antibiotic Stewardship Teams to Reduce Antibiotic Overuse at Hospital Discharge: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2549655. doi: 10.1001/jamanetworkopen.2025.49655.
PubMed 41511774
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Post-discharge Antimicrobial Use: a Multicenter Stepped Wedge Trial Study
- ClinicalTrials.gov ID
- NCT05471726
- Acronym / sponsor ID
- IRB 202109288
- Conditions
- Infections
- Keywords
- antibiotic prescriptions, hospital discharge, antibiotic stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Iowa City Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 22 May 2023 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 25 Jul 2022 (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.
One in five hospitalized patients is prescribed an antimicrobial at the time of discharge, and a large proportion of these post-discharge antimicrobials are unnecessary. The investigators will evaluate a novel method for reviewing post-discharge antimicrobial prescriptions in real-time with the goal of improving antimicrobial selection and duration.
Detailed description
Antimicrobial stewardship programs (ASPs) work to improve antibiotic prescribing within hospitals. ASPs often restrict their activities to inpatient antimicrobial-prescribing. However, at least 40% of all antimicrobial exposure associated with an acute-care hospital stay is prescribed at the time of hospital discharge (i.e., post-discharge). Post-discharge antimicrobials mediate clinical outcomes after discharge and may facilitate the spread of antimicrobial resistance.
Several studies have shown that post-discharge antimicrobial use is often inappropriate. For example, using national VA data, the investigators found that 61% of fluoroquinolone treatment days were prescribed at hospital discharge; manual chart reviews at 9 hospitals found that 40% of these post-discharge fluoroquinolone prescriptions were either unnecessary or sub-optimal. Other studies have found that 53-79% of all post-discharge antimicrobials are either unnecessary or sub-optimal.
Post-discharge antimicrobials are an important target for antimicrobial stewardship. However, inpatient stewardship metrics do not capture post-discharge antimicrobials and ASPs frequently do not evaluate these prescriptions. A 2016 VA survey found that less than 50% of hospitals routinely reviewed targeted antimicrobials at discharge. According to a 2016 survey in Michigan, only 17% of 48 hospitals had a process for reviewing outpatient antimicrobial orders at discharge.
It is unclear how inpatient stewardship resources can be effectively leveraged to improve post-discharge antimicrobial use. If the goal is to improve post-discharge antimicrobial use, a potentially effective strategy may be an audit-and-feedback process focused solely on prescriptions for patients who will soon be discharged. In this trial, the investigators will evaluate the feasibility and effectiveness of such a process.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Prospective audit-and-feedback at discharge | Experimental | Behavioral: Prospective audit-and-feedbackWhen hospitals are in the intervention arm, they will perform the audit-and-feedback process focused on patients receiving antimicrobials who have an anticipated discharge. |
| Standard of care | No intervention | –When hospitals are in the control arm, they will not perform a stewardship process that focuses on hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- --The local stewardship team agrees to implement the discharge stewardship intervention on at least one inpatient service or ward.
Key exclusion criteria (1 listed)
- --The hospital already has an audit-and-feedback process in place that focuses on antimicrobial prescribing at hospital discharge.
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 |
|---|---|---|
| Prospective audit-and-feedbackThe stewardship team will review patients who are on antibiotics, have an uncomplicated infection, and are eligible to continue antibiotics after discharge. Any recommendations from the stewardship team about optimizing antibiotic therapy will be presented to the primary prescriber in real-time with the goal of improving antibiotic selection and duration at hospital discharge. | Behavioural | Prospective audit-and-feedback at discharge |
Primary outcome
Post-discharge antibiotic length of therapy
Time frame: Every 2-week-period through study completion (48 weeks total)
The primary outcome will be post-discharge antimicrobial length of therapy (LOT) per 100 admissions. The investigators will calculate this by adding post-discharge LOT across all patients on the participating services and dividing by the number of patient-admissions discharged from those services during the study period.
2 secondary outcomes
Inpatient antibiotic length of therapy
Time frame: Every two-week period through study completion (48 weeks total)
Percentage of participants with hospital readmission
Time frame: 30 days from discharge
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 2024.
- Derived from this study: PubMed 41511774Livorsi DJ, Thompson AM, Green MS, Hoelscher AC, Chu KK, Neuner E, Burnett Y, Hopkins T, Walter E, Dave R, Tripathi R, Lohmar H, Dysangco A, Percival K, Ince D, Kolkmeyer J, Newland H, Hendrix MJ, Clore G, Poe C, O'Shea A, Tholany J, Prasidthrathsint K, Rachmiel E, Bongu J, Bewley A, Hsueh K. Prospective Audit and Feedback by Antibiotic Stewardship Teams to Reduce Antibiotic Overuse at Hospital Discharge: A Stepped-Wedge Cluster-Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2549655. doi: 10.1001/jamanetworkopen.2025.49655.
- Individual participant dataSharing planned: No. All data will be aggregated to the hospital-level without including patient identifiers. This is a requirement for transmitting data across the institutions participating in this trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective audit-and-feedback in people with Infections, run by Iowa City Veterans Affairs Medical Center at 5 sites 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: finished, as of the sponsor's last update on 8 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 5 sites 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?
Post-discharge antibiotic length of therapy (time frame: Every 2-week-period through study completion (48 weeks total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471726, which also lists 1 linked publication.
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 2024.