Antibiotic Stewardship in Community HospitalsNCT02212808
Antimicrobial Stewardship in Community Hospitals
A study testing Antimicrobial restriction and Post-antimicrobial prescription review in people with Antibiotic Stewardship in Community Hospitals, run by Duke University.
Trial summary
The Infectious Diseases Society of America (IDSA) guidelines recommend two "core" strategies for Antibiotic Stewardship (AS): 1) antimicrobial restriction and preauthorization and 2) prospective audit with intervention and feedback. Community hospitals have limited or no resources and staff dedicated to AS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic Stewardship in Community Hospitals
- What is being tested?
- Antimicrobial restriction and Post-antimicrobial prescription review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,972 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -All adult and pediatric patients admitted to the study hospital who are prescribed targeted or alternative antimicrobial agent(s) will have data collected from their medical records.
Who cannot join
- Any patient not meeting the criteria above will be excluded.
- Patients who receive < 24 hours of surgical prophylaxis with a targeted or alternative antimicrobial will be excluded.
- Finally, any patient followed by an Infectious Disease consultant will be excluded.
About this study
Official title: A Multicenter, 3-Stage Cluster Randomized Historically-Controlled Crossover Trial to Determine the Feasibility and Outcomes From Two Antimicrobial Stewardship Interventions in Community Hospitals
The Infectious Diseases Society of America (IDSA) guidelines recommend two "core" strategies for Antibiotic Stewardship (AS): 1) antimicrobial restriction and preauthorization and 2) prospective audit with intervention and feedback. Community hospitals have limited or no resources and staff dedicated to AS. Thus, understanding which of the core strategies is most feasible and effective in this practice setting would assist in appropriate allocation of limited resources. The purpose of this study is to evaluate the feasibility of implementing antimicrobial restriction and preauthorization vs. post antibiotic prescription review in resource-limited community hospitals.
Read the detailed description
This study is a three-stage cluster randomized historically controlled crossover trial designed to evaluate the feasibility of the implementation of two AS strategies. Four community hospitals in the Duke Infection Control Outreach Network (DICON) will be recruited for this study. Ideally, hospitals will have no teaching affiliation, bed size <300, and no existing antimicrobial formulary restriction and preauthorization or post-antibiotic prescription review practices in place at study start.
Data will be obtained from the four community hospitals in three stages. In stage 1, historical data from each hospital will be collected for the year prior to study initiation from all participating hospitals. These data are used as a control representing current practice. In stage 2, the four hospitals will be divided into two pairs based upon bed size. One hospital from each pair will be randomly assigned to a six-month period of antimicrobial restriction and preauthorization (Strategy 1; stage 2) followed by a six-month period of post-antibiotic prescription review (Strategy 2; stage 3). The other two hospitals will undergo Strategy 2 in stage 2 followed by Strategy 1 in stage 3 to help alleviate the concern for seasonal/temporal effects when comparing the strategies to each other. A one-month wash out will be performed between each stage. Three antibiotics will be specifically targeted for intervention: anti-pseudomonal carbapenem of choice at the study hospital, vancomycin, and piperacillin-tazobactam. Utilization of alternative antimicrobials, including fluoroquinolones, cephalosporins, and anti-methicillin resistant Staphylococcus aureus (anti MRSA) systemic antimicrobials (e.g., nafcillin, daptomycin, linezolid, ceftaroline, clindamycin, and trimethoprim-sulfamethoxazole (TMP-SMX)) will also be collected. All study hospitals will have electronic systems that track antimicrobial prescriptions through orders, electronic medication administration records (eMAR), bar-coded medication administration (BCMA), or dispensing data.
Hospitals will have dedicated clinical pharmacist time for preauthorization or post-antibiotic review for the three targeted antibiotics in each arm of the study. Pharmacists (PharmDs) at each site will receive standardized training by study personnel in order to address common questions and anticipated arguments, and to establish a robust knowledge base regarding the targeted antimicrobials (anti-pseudomonal carbapenem of choice at the study hospital, vancomycin, and piperacillin-tazobactam). They will also be trained in conflict management.
Study personnel will provide suggested criteria for appropriate use of each targeted drug. Hospital P\&T committees will review, edit (if desired), and approve hospital-specific protocols for appropriate use criteria for each study drug. Pharmacists will be provided with specific clinical pathways for urinary tract infections (UTIs), community-acquired pneumonia (CAP), healthcare-associated pneumonia (HCAP), bacteremia, and "other" uses of targeted antimicrobial. Clinical pathways will be developed jointly by study personnel and based on Centers for Disease Control and Prevention pilot projects. Clinical pharmacists will determine appropriateness of therapy based on study clinical pathways, their baseline knowledge, and acquired knowledge derived by training from study personnel. Time spent performing the two stewardship strategies will be supported by grant funds. The designated pharmacist will be involved in two critical components of the protocol: a) completing the intervention and b) documenting the outcome of the intervention.
- Being tested
- Antimicrobial restriction, Post-antimicrobial prescription review
- Keywords
- Cluster-randomized crossover trial, Antimicrobial stewardship, Community hospitals, Feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial restrictionOther
All prescriptions for targeted antibiotics will require phone approval by the trained PharmD during this arm. Prescribers will be instructed to contact the pharmacist via pager or phone call to discuss the patient details and the rationale for the desired antimicrobial. The pharmacist will then decide if the targeted antibiotic is approved or denied. If the pharmacist denies the use of the targeted antibiotic, the pharmacist will provide recommendations for alternative antibiotics for the specific clinical scenario. The pharmacist will document this interaction in the REDCap database.
Post-antimicrobial prescription reviewOther
All prescriptions for targeted antibiotics will be reviewed by the study pharmacist approximately 72 hours after initially written. The pharmacist will review and document the patient's current symptoms, pertinent clinical data, and the indication for the targeted antibiotic documented in the chart. Based on this review, the pharmacist will decide if the targeted antibiotic is necessary and/or if it needs to be modified. If a change is recommended, the pharmacist will then contact the prescriber to discuss the pharmacist's recommendations. The interaction will be documented in the REDCap database.
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial restriction | Experimental | All prescriptions for targeted antibiotics will require phone approval by the trained PharmD during this arm. Prescribers will be instructed to contact the pharmacist via pager or phone call to discuss the patient details and the rationale for the desired antimicrobial. The pharmacist will then decide if the targeted antibiotic is approved or denied. If the pharmacist denies the use of the targeted antibiotic, the pharmacist will provide recommendations for alternative antibiotics for the specific clinical scenario. Receives: Other: Antimicrobial restriction |
| Post-antimicrobial prescription review | Experimental | All prescriptions for targeted antibiotics will be reviewed by the study pharmacist approximately 72 hours after initially written. The pharmacists will review a list of patients receiving the targeted antibiotics on a daily basis to identify patients who have received one or more targeted antibiotics for 72 hours (± 24 hours). The pharmacist will review and document the patient's current symptoms, pertinent clinical data, and the indication for the targeted antibiotic documented in the chart. Based on this review, the pharmacist will decide if the targeted antibiotic is necessary and/or if it needs to be modified. If a change is recommended, the pharmacist will then contact the prescriber to discuss the pharmacist's recommendations. Receives: Other: Post-antimicrobial prescription review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility 1 - Intervention Approval
To evaluate administrative steps required for protocol approval of two stewardship intervention strategies at study hospitals.
Measured: Prior to implementation, estimated length of 3 months up to 6 months
Feasibility 2 - PharmD training
To evaluate the steps required for training of local PharmD(s) to administer the two stewardship strategies.
Measured: Prior to implementation, estimated length of 1 months up to 2 months
Feasibility 3 - PharmD Time
To estimate and compare the time required of the pharmacist to administer the different strategies.
Measured: Day of Intervention, expected length of 20 hours per week up to 52 weeks
Feasibility 4 - Resource Utilization
To estimate and compare the resource utilization of each strategy, including pharmacist time and cost of antibiotics.
Measured: During hospitalization, an expected length of 14 days, up to 30 days
Secondary outcomes (3)
Antimicrobial utilization - Days of Therapy
To compare the total days of therapy of targeted and alternative antibiotics between each strategy.
Measured: During Hospitalization, an expected length of 14 days, up to 30 days
Patient Outcomes
To compare patient-specific outcomes between each strategy including but not limited to total hospital days, death and ICU admission
Measured: During Hospitalization, an expected length of 14 days, up to 30 days
Pharmacist/Physician Perceptions
To compare the prescriber and pharmacist perceptions of the two stewardship strategies
Measured: Within 1 month of completion of intervention arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2015
- Study completionDec 2015
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 Antibiotic Stewardship in Community HospitalsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 3,972 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deverick J Anderson, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212808
- Sponsor's protocol ID
- Pro00052362
- Other IDs
- 1UM1AI104681-01
- Status last verified
- Mar 2016
- First submitted
- 1 Aug 2014
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson DJ, Watson S, Moehring RW, Komarow L, Finnemeyer M, Arias RM, Huvane J, Bova Hill C, Deckard N, Sexton DJ; Antibacterial Resistance Leadership Group (ARLG). Feasibility of Core Antimicrobial Stewardship Interventions in Community Hospitals. JAMA Netw Open. 2019 Aug 2;2(8):e199369. doi: 10.1001/jamanetworkopen.2019.9369.
PubMed 31418804
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, 3-Stage Cluster Randomized Historically-Controlled Crossover Trial to Determine the Feasibility and Outcomes From Two Antimicrobial Stewardship Interventions in Community Hospitals
- ClinicalTrials.gov ID
- NCT02212808
- Acronym / sponsor ID
- Pro00052362
- Keywords
- Cluster-randomized crossover trial, Antimicrobial stewardship, Community hospitals, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,972 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- May 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Aug 2014 (estimated)
- 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 Infectious Diseases Society of America (IDSA) guidelines recommend two "core" strategies for Antibiotic Stewardship (AS): 1) antimicrobial restriction and preauthorization and 2) prospective audit with intervention and feedback. Community hospitals have limited or no resources and staff dedicated to AS. Thus, understanding which of the core strategies is most feasible and effective in this practice setting would assist in appropriate allocation of limited resources. The purpose of this study is to evaluate the feasibility of implementing antimicrobial restriction and preauthorization vs. post antibiotic prescription review in resource-limited community hospitals.
Detailed description
This study is a three-stage cluster randomized historically controlled crossover trial designed to evaluate the feasibility of the implementation of two AS strategies. Four community hospitals in the Duke Infection Control Outreach Network (DICON) will be recruited for this study. Ideally, hospitals will have no teaching affiliation, bed size <300, and no existing antimicrobial formulary restriction and preauthorization or post-antibiotic prescription review practices in place at study start.
Data will be obtained from the four community hospitals in three stages. In stage 1, historical data from each hospital will be collected for the year prior to study initiation from all participating hospitals. These data are used as a control representing current practice. In stage 2, the four hospitals will be divided into two pairs based upon bed size. One hospital from each pair will be randomly assigned to a six-month period of antimicrobial restriction and preauthorization (Strategy 1; stage 2) followed by a six-month period of post-antibiotic prescription review (Strategy 2; stage 3). The other two hospitals will undergo Strategy 2 in stage 2 followed by Strategy 1 in stage 3 to help alleviate the concern for seasonal/temporal effects when comparing the strategies to each other. A one-month wash out will be performed between each stage. Three antibiotics will be specifically targeted for intervention: anti-pseudomonal carbapenem of choice at the study hospital, vancomycin, and piperacillin-tazobactam. Utilization of alternative antimicrobials, including fluoroquinolones, cephalosporins, and anti-methicillin resistant Staphylococcus aureus (anti MRSA) systemic antimicrobials (e.g., nafcillin, daptomycin, linezolid, ceftaroline, clindamycin, and trimethoprim-sulfamethoxazole (TMP-SMX)) will also be collected. All study hospitals will have electronic systems that track antimicrobial prescriptions through orders, electronic medication administration records (eMAR), bar-coded medication administration (BCMA), or dispensing data.
Hospitals will have dedicated clinical pharmacist time for preauthorization or post-antibiotic review for the three targeted antibiotics in each arm of the study. Pharmacists (PharmDs) at each site will receive standardized training by study personnel in order to address common questions and anticipated arguments, and to establish a robust knowledge base regarding the targeted antimicrobials (anti-pseudomonal carbapenem of choice at the study hospital, vancomycin, and piperacillin-tazobactam). They will also be trained in conflict management.
Study personnel will provide suggested criteria for appropriate use of each targeted drug. Hospital P\&T committees will review, edit (if desired), and approve hospital-specific protocols for appropriate use criteria for each study drug. Pharmacists will be provided with specific clinical pathways for urinary tract infections (UTIs), community-acquired pneumonia (CAP), healthcare-associated pneumonia (HCAP), bacteremia, and "other" uses of targeted antimicrobial. Clinical pathways will be developed jointly by study personnel and based on Centers for Disease Control and Prevention pilot projects. Clinical pharmacists will determine appropriateness of therapy based on study clinical pathways, their baseline knowledge, and acquired knowledge derived by training from study personnel. Time spent performing the two stewardship strategies will be supported by grant funds. The designated pharmacist will be involved in two critical components of the protocol: a) completing the intervention and b) documenting the outcome of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial restriction | Experimental | Other: Antimicrobial restrictionAll prescriptions for targeted antibiotics will require phone approval by the trained PharmD during this arm. Prescribers will be instructed to contact the pharmacist via pager or phone call to discuss the patient details and the rationale for the desired antimicrobial. The pharmacist will then decide if the targeted antibiotic is approved or denied. If the pharmacist denies the use of the targeted antibiotic, the pharmacist will provide recommendations for alternative antibiotics for the specific clinical scenario. |
| Post-antimicrobial prescription review | Experimental | Other: Post-antimicrobial prescription reviewAll prescriptions for targeted antibiotics will be reviewed by the study pharmacist approximately 72 hours after initially written. The pharmacists will review a list of patients receiving the targeted antibiotics on a daily basis to identify patients who have received one or more targeted antibiotics for 72 hours (± 24 hours). The pharmacist will review and document the patient's current symptoms, pertinent clinical data, and the indication for the targeted antibiotic documented in the chart. Based on this review, the pharmacist will decide if the targeted antibiotic is necessary and/or if it needs to be modified. If a change is recommended, the pharmacist will then contact the prescriber to discuss the pharmacist's recommendations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -All adult and pediatric patients admitted to the study hospital who are prescribed targeted or alternative antimicrobial agent(s) will have data collected from their medical records.
Key exclusion criteria (3 listed)
- Any patient not meeting the criteria above will be excluded.
- Patients who receive < 24 hours of surgical prophylaxis with a targeted or alternative antimicrobial will be excluded.
- Finally, any patient followed by an Infectious Disease consultant will be excluded.
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 |
|---|---|---|
| Antimicrobial restrictionAll prescriptions for targeted antibiotics will require phone approval by the trained PharmD during this arm. Prescribers will be instructed to contact the pharmacist via pager or phone call to discuss the patient details and the rationale for the desired antimicrobial. The pharmacist will then decide if the targeted antibiotic is approved or denied. If the pharmacist denies the use of the targeted antibiotic, the pharmacist will provide recommendations for alternative antibiotics for the specific clinical scenario. The pharmacist will document this interaction in the REDCap database. | Other | Antimicrobial restriction |
| Post-antimicrobial prescription reviewAll prescriptions for targeted antibiotics will be reviewed by the study pharmacist approximately 72 hours after initially written. The pharmacist will review and document the patient's current symptoms, pertinent clinical data, and the indication for the targeted antibiotic documented in the chart. Based on this review, the pharmacist will decide if the targeted antibiotic is necessary and/or if it needs to be modified. If a change is recommended, the pharmacist will then contact the prescriber to discuss the pharmacist's recommendations. The interaction will be documented in the REDCap database. | Other | Post-antimicrobial prescription review |
Primary outcome
Feasibility 1 - Intervention Approval
Time frame: Prior to implementation, estimated length of 3 months up to 6 months
To evaluate administrative steps required for protocol approval of two stewardship intervention strategies at study hospitals.
Feasibility 2 - PharmD training
Time frame: Prior to implementation, estimated length of 1 months up to 2 months
To evaluate the steps required for training of local PharmD(s) to administer the two stewardship strategies.
Feasibility 3 - PharmD Time
Time frame: Day of Intervention, expected length of 20 hours per week up to 52 weeks
To estimate and compare the time required of the pharmacist to administer the different strategies.
Feasibility 4 - Resource Utilization
Time frame: During hospitalization, an expected length of 14 days, up to 30 days
To estimate and compare the resource utilization of each strategy, including pharmacist time and cost of antibiotics.
3 secondary outcomes
Antimicrobial utilization - Days of Therapy
Time frame: During Hospitalization, an expected length of 14 days, up to 30 days
Patient Outcomes
Time frame: During Hospitalization, an expected length of 14 days, up to 30 days
Pharmacist/Physician Perceptions
Time frame: Within 1 month of completion of intervention arm
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 22 Mar 2016.
- Derived from this study: PubMed 31418804Anderson DJ, Watson S, Moehring RW, Komarow L, Finnemeyer M, Arias RM, Huvane J, Bova Hill C, Deckard N, Sexton DJ; Antibacterial Resistance Leadership Group (ARLG). Feasibility of Core Antimicrobial Stewardship Interventions in Community Hospitals. JAMA Netw Open. 2019 Aug 2;2(8):e199369. doi: 10.1001/jamanetworkopen.2019.9369.
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.
Deverick J Anderson, MD, MPH principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial restriction and Post-antimicrobial prescription review in people with Antibiotic Stewardship in Community Hospitals, run by Duke University.
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 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 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Feasibility 1 - Intervention Approval (time frame: Prior to implementation, estimated length of 3 months up to 6 months). The study lists 4 primary outcomes in all. 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 NCT02212808, 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 22 Mar 2016.