Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Length of Stay of Immune-competent Adult Patients Admitted to a Hospital Ward With a Diagnosis of Community-acquired Pneumonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 763
- Locations
- 1
- Primary Endpoint
- Hospital length of stay
Study Overview
Brief Summary
The purpose of the study is to determine whether an antimicrobial stewardship program can decrease the length of hospital stay for patients with pneumonia. The antimicrobial stewardship program is run by a pharmacist and doctor with extensive training in managing infectious diseases. These two health care professionals are responsible for reviewing the records of patients admitted to hospital with pneumonia, and then making specific recommendations to the patient's attending physician about how to manage antibiotic treatment. These recommendations might include discontinuing the antibiotic, or changing the way antibiotics are delivered from intravenous form to pill form, among many other potential options. The attending physician considers whether these recommendations should be followed or rejected. The study has a control group of patients who are not reviewed by the antimicrobial stewardship team, and their length of hospital stay will be compared to the reviewed group of patients. Any differences between these two groups will be assumed to be due to the impact of the antimicrobial stewardship program. So far, no previous study has been able to demonstrate that an antimicrobial stewardship program can reduce the length of stay of patients admitted to hospital with pneumonia. This study has some important differences from previous studies that may make its conclusions more accurately reflect the true impact of antimicrobial stewardship programs. The most important difference is how the timing of the review is modelled in the analysis of the study results. Because the timing of the review varies between patients, with some patients being reviewed at earlier and some at later times, this subtle difference, if not accounted for in the analysis, can mask a true positive effect of the program on length of stay. The investigators study will account for this variation.
Detailed Description
In immune-competent adult patients admitted to a hospital ward with a diagnosis of community-acquired pneumonia, does a multi-faceted ASP utilizing prospective chart audit and feedback compared with usual care reduce the LOS without increasing the risk of death or readmission at 30 days post-discharge from hospital? In Ontario, pneumonia is the leading cause of death from bacterial infections and accounts for over 18,000 years of life lost annually due to premature mortality. Pneumonia accounts for the majority of antibiotic utilization in both hospital and outpatient settings. Evidence-based guidelines for the diagnosis and management of pneumonia are available to physicians. Adherence to these evidence-based guidelines is associated with both reduced mortality and antibiotic utilization.
Antimicrobial stewardship is defined as any intervention that minimizes unwarranted variation in antimicrobial utilization from evidence-based best practice with the intent of improving patient safety and quality of care. Unwarranted refers to the absence of patient- or disease-specific reasons to justify practice variation from evidence-based practice standards. Antimicrobial stewardship can be operationalized in many different ways, but prospective audit and feedback (persuasive approach) and restricted antimicrobial prescribing policies (restrictive approach) appear to be the most efficacious interventions to achieve the goals of antimicrobial stewardship. Antimicrobial stewardship programs have demonstrated efficacy in improving antimicrobial prescribing and reducing rates of hospital-acquired infections. Antimicrobial stewardship programs directed to CAP patients have demonstrated reductions in mortality, but have failed to demonstrate reductions in length of stay.
All participants will be admitted patients to the Royal Victoria Regional Health Centre (RVRHC), a 319 bed community-based, university-affiliated, acute care hospital located in Barrie, Ontario, Canada.
All patients enrolled in the study will be admitted to one of four medical wards. All study patients will be admitted to a hospitalist service. Admission to any medical ward is controlled by bed allocation, a non-medical administrative service within the hospital responsible for patient flow and assigning patient care. Hospitalists are not assigned to any one specific medical ward, but provide care across all medical wards.
All eligible CAP who meet the ASP review criteria will be exposed to the ASP intervention. The ASP intervention (ASP-i) consists of a prospective chart audit and physician feedback (persuasive) approach . The ASP members who conduct all the audits and make recommendations consist of an infectious diseases-trained pharmacist (LM) and an infectious diseases trained physician (GD). All patients are reviewed by both members. The ASP intervention (ASP-i) recommendations are guided by the Infectious Diseases Society of America CAP guidelines and the Canadian Thoracic Society guidelines for the management of chronic obstructive pulmonary disease. The possible ASP-i recommendations are based on those recommended by the National Health Service in the United Kingdom and include the following:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have a positive Febrile Respiratory Illness (FRI) screen on admission to hospital (http://www.health.gov.on.ca/fr/public/programs/emu/sars/reports/dir_122303_acute_care_nonoutbreak.pdf)
- •diagnosed with pneumonia by the admitting physician (Acute exacerbations of chronic obstructive lung disease are considered within the definition of pneumonia for the purposes of this study as they are commonly treated with the same antimicrobial regimens as patients with pneumonia)
- •admitted to a medical ward
Exclusion Criteria
- •hospitalized for ≥ 48 consecutive hours in the preceding 3 months
- •receiving immunosuppressants [defined as ≥ 40 mg prednisone daily (or steroid equivalent) for ≥ 2 weeks preceding hospitalization OR any other immunosuppressant used for systemic illness OR to prevent transplant rejection]
- •neutropenic [defined as a polymorphonuclear count ≤ 0.5 x 109 cells/L] from any cause
- •immunocompromised [defined as having leukemia, lymphoma, HIV with CD4 cell count ≤ 200, splenectomy or on cytotoxic chemotherapy]
- •admitted to high acuity units such as intensive care units
- •require mechanical ventilation, either non-invasive or invasive
- •have a life expectancy of ≤ 3 months (palliative)
Outcomes
Primary Outcomes
Hospital length of stay
Time Frame: Patients will be followed for 14 days from date of admission and if not discharged will be administratively censored
Time to discharge or censoring event
Secondary Outcomes
- 30-day post-discharge mortality rate(30 calendar days after hospital discharge)
- Duration of antimicrobial therapy(Total duration of all antibiotics administered starting from date of administration of first antibiotic to date of discontinuation of last antibiotic (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge from hospital)
- 30-day post-discharge readmission rate(30 calendar days after hospital discharge)
- Days of antimicrobial therapy(Total days of antimicrobial therapy for each antibiotic calculated from date of first administration on admission to hospital to date of discontinuation (or to date of censoring, whichever comes first) upto a maximum of 30 days post-discharge follow-up)
Investigators
Giulio DiDiodato
Medical Lead, Antimicrobial Stewardship Program
Royal Victoria Hospital, Canada