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

NCT ID: NCT06706583

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-03-31

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).

Conditions

Community Acquired Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Enhanced education arm

Telematic educational interviews are added to standard PIRASOA training

Group Type: EXPERIMENTAL

Telematic educational interviews + standard training

Intervention Type: 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).

Standard education arm

Only standard PIRASOA training is provided

Group Type: ACTIVE_COMPARATOR

Standard training

Intervention Type: BEHAVIORAL

Primary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA).

Interventions

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).

Intervention Type: BEHAVIORAL

Standard training

Primary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Miguel Cisneros Herreros, MD-PhD

Role: STUDY_DIRECTOR

Hospitales Universitarios Virgen del Rocío

Locations

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Clara M Rosso Fernández, MD-PhD

Role: CONTACT

claram.rosso.sspa@juntadeandalucia.es

+34955013414

Jose Molina Gil-Bermejo, MD-PhD

Role: CONTACT

josemolinagb@gmail.com

Facility Contacts

Jose Molina Gil-Bermejo, MD-PhD

Role: primary

josemolinagb@gmail.com

Other Identifiers

TELÉMACO

Identifier Type: -

Identifier Source: org_study_id