Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews (TELÉMACO Trial)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Enrolling

Conditions: Community Acquired Infections

Treatments: Behavioral: Standard training; Behavioral: Telematic educational interviews + standard training

Study type: Interventional

Funder types: Other

Identifiers

NCT06706583

TELÉMACO

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Enhanced education arm

Experimental group

Description:

Telematic educational interviews are added to standard PIRASOA training

Treatment:

Behavioral: Telematic educational interviews + standard training

Standard education arm

Active Comparator group

Description:

Only standard PIRASOA training is provided

Treatment:

Behavioral: Standard training