RASPCAP: Impact of a Regional Antimicrobial Stewardship on the Length of Stay of Patients Admitted to Hospital With Pneumonia

Sponsor

Royal Victoria Hospital, Canada (Other)

Overall Status

Completed

CT.gov ID

NCT02276092

Collaborator

(none)

1,400

Enrollment

Location

Duration (Months)

58.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the effectiveness of an antimicrobial stewardship program to reduce the length of stay of patients admitted to hospital with a diagnosis of pneumonia. The antimicrobial stewardship program will be implemented in several hospitals in Ontario, Canada. The program will identify patients with pneumonia, review their charts and make recommendations to their attending physicians about antibiotic management.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia	Other: antimicrobial stewardship

Detailed Description

Antimicrobial stewardship is defined as any activity that promotes the appropriate selection, dosing, route and duration of antibiotic therapy. Antimicrobial stewardship programs usually include pharmacists and/or doctors with expertise in infection diseases management. Prospective chart review and physician feedback is a common intervention used by antimicrobial stewardship programs to improve antibiotic utilization and patient outcomes.

Pneumonia is the most common reason for antibiotic utilization in hospitals. Significant variation in antibiotic utilization for patients with pneumonia has been repeatedly demonstrated in published studies despite the existence of best-practice treatment guidelines. Treatment variation from these guidelines has been demonstrated to result in worse outcomes such as increased mortality. Antimicrobial stewardship programs can help reduce the treatment variation from guidelines.

Despite improvements in certain outcomes, antimicrobial stewardship programs have not demonstrated any impact on the length of stay of patients admitted to hospital with pneumonia. Part of this absence of evidence may be due to poor study design and failure to recruit sufficient patients. This study will include the implementation of an antimicrobial stewardship program across many hospitals and the study design and analysis will account for the design problems of the previous studies.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effectiveness of a Regional Antimicrobial Stewardship Program to Reduce the Length of Stay of Patients Admitted to Hospital With Community-acquired Pneumonia: a Pragmatic Multi-centre Clinical Study

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
intervention exposure to antimicrobial stewardship intervention	Other: antimicrobial stewardship A member of the antimicrobial stewardship program will prospectively review the patient's medical record and make recommendations to the most responsible physician in the care of that patient Other Names: prospective audit and feedback
control usual care with no exposure to antimicrobial stewardship

Arm

Intervention/Treatment

intervention

exposure to antimicrobial stewardship intervention

Other: antimicrobial stewardship

A member of the antimicrobial stewardship program will prospectively review the patient's medical record and make recommendations to the most responsible physician in the care of that patient

Other Names:

prospective audit and feedback

control

usual care with no exposure to antimicrobial stewardship

Outcome Measures

Primary Outcome Measures

Length of hospital stay [Days from time of admission to time of discharge from hospital to a maximum of 14 days from the date of admission (or time to censoring at 14 days from the date of admissionor competing event depending on which comes first)]
Time (measured in days) from date of admission to one of the following potential outcomes, discharge alive, censoring at 14 days post admission, death, admission to an intensive care unit, or transfer to another hospital

Secondary Outcome Measures

Days of antibiotic therapy [Days of antibiotic therapy for the treatment of pneumonia measured from the first day of antibiotic administered to the final day of antibiotic administered upto a maximum of 80 days]
Total days of antibiotics administered for the treatment of community-acquired pneumonia
Mortality rate [30 day post-discharge from hospital]
Deaths that occur post-discharge from hospital up to 30 days post-discharge
Readmission to hospital [30 day post-discharge from hospital]
Readmissions to hospital that occur post-discharge from hospital up to 30 days post-discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Community-acquired pneumonia
Immunocompetent
Age > 18 years

Exclusion Criteria:

Admitted to an intensive care unit or high intensity unit
Requiring invasive or non-invasive ventilation
Life expectancy less than 3 months
Hospitalization within the previous 3 months for at least 48 consecutive hours
Immunocompromised defined as defined as having leukemia, lymphoma, HIV with CD4 count <=200, splenectomy or on cytotoxic chemotherapy
Neutropenic [defined as a PMN count<=0.5x109 cells/L] from any cause
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