NCT06706583

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Community Acquired Infections

Interventions

Type	Name	Description
BEHAVIORAL	Telematic 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).
BEHAVIORAL	Standard training	Primary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA).

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-11-26
• Last updated: 2024-11-26

Locations

1 site across 1 country: Spain