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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced education arm | Experimental | Telematic educational interviews are added to standard PIRASOA training |
|
| Standard education arm | Active Comparator | Only standard PIRASOA training is provided |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telematic educational interviews + standard training | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Total antimicrobial consumption | 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. | Monthly over a 36-month period |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of antimicrobial prescriptions | The rate of appropriate antimicrobial prescriptions according to national reference guidelines will be assessed through three point prevalence surveys of randomly selected prescriptions. | Prevalence surveys will be performed at months +0, +7 and +15. |
| Incidence density of hospitalizations due to infections |
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Inclusion criteria:
a) Primary Care centres within the reference area of the University Hospital Virgen del RocÃo.
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara M Rosso Fernández, MD-PhD | Contact | +34955013414 | claram.rosso.sspa@juntadeandalucia.es | |
| Jose Molina Gil-Bermejo, MD-PhD | Contact | josemolinagb@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| José Miguel Cisneros Herreros, MD-PhD | Hospitales Universitarios Virgen del RocÃo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del RocÃo | Recruiting | Seville | 41013 | Spain |
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Cluster randomized clinical trial
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|
| Standard training | Behavioral | Primary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA). |
|
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. |
| Monthly, over a 36-month period. |
| Incidence density of resistant Enterobacterales in urine cultures | Incidence density of resistant Enterobacterales in urine cultures per inhabitant sent from Primary Care centers from both arms. | Monthly, over a 36-month period. |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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