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NCT Number: NCT06706583

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location status: Recruiting

Location contact

Jose Molina Gil-Bermejo

PRINCIPAL_INVESTIGATOR

Jose Molina Gil-Bermejo, MD-PhD

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

a) Primary Care centres within the reference area of the University Hospital Virgen del Rocío.

Exclusion criteria

  • Emergency departments.
  • Odontology offices.
  • DDD per Health centre less than 5.78

Treatment and study plan

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).

Standard training

Behavioral

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

Primary outcomes

  1. Total antimicrobial consumption

    Time frame: Monthly over a 36-month period

    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.

Secondary outcomes

  1. Adequacy of antimicrobial prescriptions

    Time frame: Prevalence surveys will be performed at months +0, +7 and +15.

    The rate of appropriate antimicrobial prescriptions according to national reference guidelines will be assessed through three point prevalence surveys of randomly selected prescriptions.

  2. Incidence density of hospitalizations due to infections

    Time frame: Monthly, over a 36-month period.

    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.

  3. Incidence density of resistant Enterobacterales in urine cultures

    Time frame: Monthly, over a 36-month period.

    Incidence density of resistant Enterobacterales in urine cultures per inhabitant sent from Primary Care centers from both arms.

Study contacts

Contact information is provided by the study sponsor or research team.

Clara M Rosso Fernández, MD-PhD

CONTACT

[email protected]

+34955013414

Jose Molina Gil-Bermejo, MD-PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

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

Acronym: TELÉMACO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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