An interventional study of Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia in Community-acquired Pneumonia, sponsored by Instituto de Investigacion Sanitaria La Fe. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Not applicable, Interventional, and Health services research
International and national clinical guidelines recommend short antibiotic regimens in patients with non-severe community-acquired pneumonia (CAP) who have reached clinical stability. However, adherence to these recommendations remains unclear. The goals of this quasi-experimental trial are: 1) to assess adherence to clinical guidelines in relation to the duration of antibiotic treatment in patients hospitalized for non-severe CAP who have reached clinical stability; 2) increase adherence to clinical guidelines and reduce the use of antibiotics in patients hospitalized for non-severe CAP who have achieved clinical stability after at least 5 days of antibiotic treatment.
To this end, a multicenter prospective study will be carried out over 2 years and divided into 2 phases: i) during the first year (observational phase), patients with CAP hospitalized in the participating centers will be recorded to assess objective 1; ii) to achieve objective 2, at the beginning of the second year (quasi-experimental trial) the centers will be randomized into 2 groups of hospitals, one of them a control group and the other an intervention group. The intervention will consist in automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Patients allocated in hospitals randomized to non-interventional arm. Observational analysis of patients treated by clinicians with standard of care.
Patients allocated in hospitals randomized to interventional arm. Intervention: automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability
Behavioral: Reminders to the assistant clinicians of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment community-acquired pneumonia
Automatic reminders through pop-up windows in the computerized prescription software, reminding the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability
Also known as: Reminders to the clinician responsible for each patient of the need to adhere to clinical guidelines regarding the duration of antibiotic treatment in patients with clinical stability
Duration of antibiotic treatment
Total duration in days of antibiotic treatment (including the days of outpatient antibiotic prescribed at discharge).
Time frame: 90 days
Duration of antibiotic treatment after reaching clinical stability
Duration in days of antibiotic treatment after reaching clinical stability
Time frame: 90 days
Patients treated with an adequate duration of 5±1 days
Percentage of patients treated with an adequate duration of 5±1 days
Time frame: 90 days
Patients admitted to the ICU after the 5th day
Percentage of patients admitted to the ICU after the 5th day of admission
Time frame: 90 days
Mortality
Percentage of patients who died during the study
Time frame: 90 days
Readmission
Percentage of patients who are readmitted after hospital discharge
Time frame: 90 days
Reintroduction of antibiotic treatment
Percentage of patients with reintroduction of antibiotic treatment
Time frame: 90 days
Length of hospital stay
Length of hospital stay in days
Time frame: 90 days
Adverse events related to antibiotic treatment
Percentage of patients with adverse events related to antibiotic treatment
Time frame: 90 days
Factors related to excess of antibiotic treatment
Factors o variables related to excess of antibiotic treatment
Time frame: 90 days
Plan to share: Yes
Supporting information: Study protocol, Csr
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Instituto de Investigacion Sanitaria La Fe