Clinical trial NCT06706583: Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews (TELÉMACO Trial)
Official title: Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews. A Cluster Randomized Clinical Trial (TELÉMACO Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Community Acquired Infections
Keywords: Antimicrobial Stewardship Program (ASP)
Primary Care
Telemedicine
PIRASOA
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized clinical trial
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Total antimicrobial consumption
timeFrame: Monthly over a 36-month period
Secondary outcomes:
measure: Adequacy of antimicrobial prescriptions
timeFrame: Prevalence surveys will be performed at months +0, +7 and +15.
measure: Incidence density of hospitalizations due to infections
timeFrame: Monthly, over a 36-month period.
measure: Incidence density of resistant Enterobacterales in urine cultures
timeFrame: Monthly, over a 36-month period.
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: José Miguel Cisneros Herreros, MD-PhD
role: STUDY_DIRECTOR
References: