Antimicrobial Stewardship in Community Hospitals

NCT02212808 | Completed DMC

• 2 other identifiers: Pro000523621UM1AI104681-01
• Study Type: interventional
• Target: 3,972
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Antibiotic Stewardship in Community Hospitals

Keywords

Cluster-randomized crossover trial; Antimicrobial stewardship; Community hospitals; Feasibility

Outcome Measures

Primary Outcomes (4)

• Feasibility 1 - Intervention Approval

  To evaluate administrative steps required for protocol approval of two stewardship intervention strategies at study hospitals.

  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.

  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.

  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.

  During hospitalization, an expected length of 14 days, up to 30 days

Secondary Outcomes (3)

• Antimicrobial utilization - Days of Therapy

  During Hospitalization, an expected length of 14 days, up to 30 days

• Patient Outcomes

  During Hospitalization, an expected length of 14 days, up to 30 days

• Pharmacist/Physician Perceptions

  Within 1 month of completion of intervention arm

Study Arms (2)

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.

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.

Other: Post-antimicrobial prescription review

Interventions

Antimicrobial restriction OTHER

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.

Antimicrobial restriction

Post-antimicrobial prescription review OTHER

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.

Post-antimicrobial prescription review

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Related Publications (1)

• 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.

  PMID: 31418804 DERIVED

Study Officials

• Deverick J Anderson, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 8, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-03