Community Acquired Infections
Conditions
Keywords
Antimicrobial Stewardship Program (ASP), Primary Care, Telemedicine, PIRASOA
Brief summary
Brief Summary: Open-label, cluster randomized, multicenter clinical trial to evaluate the clinical and ecological impact of a Primary Care ASP based on telematic educational interviews.
Detailed description
The objective of this project is to measure the effect of an Antimicrobial Stewardship Program (ASP) in Primary Care, based on an educational intervention. This will consist of periodic structured telematic educational interviews between Infectious Diseases experts and Family Medicine and paediatrics specialists. In these interviews, the principles for the optimal use of antimicrobials will be addressed on real cases, analyzing together prescriptions randomly chosen from the Primary Care physician himself. The repetition over time of key pedagogical messages for the optimisation of prescriptions is expected to improve the quality of antibiotic use, reduce the overall consumption, improve the use of microbiological tests, reduce the incidence of community infections caused by resistant microorganisms, and preserve patients' safety measured by the rate of admission for serious infections. The results derived from these educational interventions, in the framework of a multimodal ASP, have been evaluated in hospital and Primary Care settings in quasi-experimental studies with a favourable outcome, but not in a clinical trial that specifically assesses the efficacy of educational interviews and avoids the bias of uncontrolled studies. To demonstrate this hypothesis, a cluster randomized trial has been designed, in wich all healthcare centers will be assigned either to a control group (the standard measures defined by the regional ASP PIRASOA will be maintained), and an experimental group (whose physicians will receive the educational intervention described).
Interventions
BEHAVIORALTelematic educational interviews + standard training
Physicians attending at healthcare centers in the experimental arm will receive periodic telematic educational interviews in which an Infectious Diseases consultant will provide practical training on the appropriate use of antibiotics through the review of one of the physician´s randomly chosen antibiotic prescription, according to a structured brief interview. In addition to this, each of these centres will continue carrying out the already established activities of the Regional ASP (PIRASOA).
BEHAVIORALStandard training
Primary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA).
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Cluster randomized clinical trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
a) Primary Care centres within the reference area of the University Hospital Virgen del Rocío.
Exclusion criteria
1. Emergency departments. 2. Odontology offices. 3. DDD per Health centre less than 5.78
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total antimicrobial consumption | Monthly over a 36-month period | Total antimicrobial antimicrobial will be measured using the recommended international standard, the Defined Daily Dose (DDD) per 1000 inhabitants per day. Predefined subgroup analyses will be conducted to assess the intervention's effect on the primary outcome based on: patient age, geneder, and socioeconomic level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of antimicrobial prescriptions | Prevalence surveys will be performed at months +0, +7 and +15. | The rate of appropriate antimicrobial prescriptions according to national reference guidelines will be assessed through three point prevalence surveys of randomly selected prescriptions. |
| Incidence density of hospitalizations due to infections | Monthly, over a 36-month period. | The incidence density of hospitalizations due to infections (urinary, pneumonia and skin and soft tissue infections), and specifically due to Clostridiodes difficile infections per inhabitant. |
| Incidence density of resistant Enterobacterales in urine cultures | Monthly, over a 36-month period. | Incidence density of resistant Enterobacterales in urine cultures per inhabitant sent from Primary Care centers from both arms. |
Countries
Spain
Contacts
Primary ContactClara M Rosso Fernández, MD-PhD
Backup ContactJose Molina Gil-Bermejo, MD-PhD
Outcome results
None listed