Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals

The purpose of this study is to evaluate the impact of a structured package (bundle) in reducing the use of antimicrobials and hospital stay of patients with community-acquired pneumonia (CAP), and no increase in mortality of these patients in different hospitals.

Study Overview

• Status: Unknown
• Conditions: Community Acquired Pneumonia

• Study Type: Observational
• Enrollment (Anticipated): 968

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41092
    • Recruiting
    • Fundación Pública Progreso y Salud
    • Contact: María del Mar Benjumea Vargas; Phone Number: 0034955040450; Email: gestionensayosclinicos.fps@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pre-intervention period

All patients admitted with a diagnosis of CAP will be included in the participating centers during the 12 months prior to the intervention. Case detection is done through the electronic record of the basic minimum data set (MDS) (2, 36). Diagnosed patients will be selected at discharge: "simple acute bronchitis and pneumonia excluding asthma major criteria" (by diagnosis related group, DRG 541) and "simple and pleuritis in over 17 Pneumonia" (DRG 089).

Post-intervention period

All patients admitted with a diagnosis of CAP in the participating centers, which measures the bundle will apply prospectively included. Case detection was performed by daily review of patients admitted to target units and will be coordinated by the IP address of each center.

Description

Inclusion Criteria:

• Diagnosis of CAP at hospital admission .
• Age: 18 years or more.

Exclusion Criteria:

• Patients with nosocomial pneumonia or criteria related to health care.
• Patients with severe immunosuppression (HIV infection with <200 CD4+ lymphocytes / mm3), neutropenia (<500 neutrophils / mm3).
• Patient treated with immunosuppressive drugs.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pre-intervention All patients admitted with a diagnosis of CAP
Post intervention All patient admitted with a diagnosis of CAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antimicrobial use in patients hospitalized for CAP.	It is measured in defined daily doses (DDD) per 100 hospital stay of patients hospitalized with CAP.	twelve months
Mortality rate to 30 days	Number of death of patients hospitalized with CAP, stratified by CURB-65 score.	twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAP severity CURB-65 or PSI registered.	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Numbers of doctors who register on the clinical history the evaluation of CAP severity by CURB-65 or PSI at hospitalization.	twelve months
Microbiological samples at admission.	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Numbers of doctors who taking all microbiological samples recommended in the guideline in the first 6 hours of patient admission.	twelve months
Appropriate supportive treatment	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who take supportive treatment according to guideline during the hospitalization.	Twelve months
Empirical treatment	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who prescribed empirical treatment according to the guideline at admission.	Twelve months
Appropriate sequential therapy.	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who switch to oral therapy according to guideline.	Twelve months
Specific antimicrobial treatment	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who prescribed the specific antimicrobial treatment defined in the guideline	Twelve months
Total duration of antibiotic therapy.	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who prescribe an antimicrobial treatment during 7 days or less, or 5 days or less after clinical improvement.	Twelve months

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza Progreso y Salud
• Investigators: Study Director: Pilar Retamar Gentil, Hospital Universitario Virgen Macarena; Principal Investigator: Juan Enrique Corzo Delgado, Hospital Universitario Virgen de Valme; Principal Investigator: Cristina Roca Oporto, Hospitales Universitarios Virgen del Rocío; Principal Investigator: Montserrat Pérez Pérez, Hospital de la Línea de la Concepción; Principal Investigator: Salvador López Cardenas, Hospital De Jerez De La Frontera; Principal Investigator: María del Carmen Almodóvar Pulido, Hospital de Antequera; Principal Investigator: Fernando Nebrera Navarro, Hospital de Formentera; Principal Investigator: Rosario Javier Martínez, University Hospital Virgen de las Nieves; Principal Investigator: Francisca Guerrero Sánchez, Hospital Universitario Puerta Del Mar

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Estimate): June 12, 2015
• Last Update Submitted That Met QC Criteria: June 11, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: FIS-ANT-2014-01