Pneumonia Clinical Trial
Official title:
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
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.
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:
i) No change to current care ii) Discontinue antibiotic(s) iii) Intravenous to oral
conversion iv) Duration of therapy v) Dosing change vi) Narrow or broaden spectrum of therapy
The ASP-i recommendations are not mutually exclusive. All recommendations are documented in
the patient's electronic medical record and communicated directly to the attending physician
by the ASP members.
This is a pragmatic controlled clinical study intended to measure the effectiveness of a
'real world' program. The ASP-i will be implemented in a modified stepped wedge design;
baseline patient data will be collected for all enrolled patients on each of the medical
wards for the first three months of the study, and then the ASP-i will be introduced to each
medical ward in a non-randomized sequential fashion in two month intervals until all medical
wards are exposed to the intervention.
The unit of analysis will be individual patients adjusted for potential clustering effects
within hospital wards.
The primary outcome is length of hospital stay (LOS) measured in minutes from the documented
time of admission to the documented time of discharge (or censoring). All patients will be
administratively censored at 14 days after hospital admission if they have not been
discharged home.
Enrollment of patients started on April 1, 2013. The study is expected to enroll patients
until March 31, 2015. All consecutive patients that meet the inclusion criteria and have no
exclusion criteria will be eligible for the intervention. The ASP-i intervention may be
implemented anytime after 48 hours post-admission in those patients who meet the criteria for
ASP review. All patients who have not experienced an outcome at 14 days after admission will
be censored from the study. Patients who die or are transferred from the ward (to the
intensive care unit or other hospital) will also be censored. Patients who are discharged
from hospital and are not censored will be contacted at 30 days post-discharge to determine
their adherence with antibiotic prescription (if relevant), survival status and readmission
status.
The sample size expected for the current study is 'fixed' and has been previously estimated
to be between 400 to 500 CAP patients per calendar year. The accrual period will be 24
months. Assuming 70% of patients in the control arm will achieve the primary outcome of being
discharged alive from hospital, and setting power = 0.8 and statistical significance
(2-sided) α = 0.05, the detectable ASP-i effect size is estimated to be up to an
approximately 20% reduction in length of stay.
An extended Cox regression analysis will be used to compare the primary and secondary
outcomes between the control and intervention groups. Violations of the proportional hazards
assumption for each covariate will be identified by using the method of Schoenfeld residuals.
Results will be reported as hazard ratios with 95% confidence intervals. Time to ASP-i will
be modeled as a time-variant covariate in the final model to account for any time-dependent
bias.
Other variables known to be associated with the primary and secondary outcomes will also be
included in the final model, and include; age, sex, charlson comorbidity index, CURB-65
score, time (days) to clinical resolution, and complications from pneumonia such as empyema.
Fixed effects of wards on the outcomes will accounted for by including them as indicator
variables in the final model. Maturation of ASP-i effect on outcomes over time will be
adjusted by including a categorical time variable in the final model (time variable will be
defined as 'quarter' from start of study). A dichotomous variable for acceptance or rejection
of the ASP-i will be part of an interaction term with the control/intervention group variable
to permit a per protocol analysis.
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