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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Community Acquired Infections
• Intervention / Treatment: Behavioral: Telematic educational interviews + standard training; Behavioral: Standard training

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clara M Rosso Fernández, MD-PhD; Phone Number: +34955013414; Email: claram.rosso.sspa@juntadeandalucia.es
• Study Contact Backup: Name: Jose Molina Gil-Bermejo, MD-PhD; Email: josemolinagb@gmail.com

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
    • Contact: Jose Molina Gil-Bermejo, MD-PhD; Email: josemolinagb@gmail.com
    • Principal Investigator: Jose Molina Gil-Bermejo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced education arm; Telematic educational interviews are added to standard PIRASOA training	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).
Active Comparator: Standard education arm; Only standard PIRASOA training is provided	Behavioral: Standard training; Primary Care Health Centers assigned to the control group will receive standard educational activities designated by the current Regional ASP (PIRASOA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Study Director: José Miguel Cisneros Herreros, MD-PhD, Hospitales Universitarios Virgen del Rocío

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; Primary Care; Antimicrobial Stewardship Program (ASP); PIRASOA
• Additional Relevant MeSH Terms: Infections; Community-Acquired Infections
• Other Study ID Numbers: TELÉMACO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No