Clinical/Microbiological Impact of a Specific Antimicrobial Stewardship Program for Nursing Homes

NCT ID: NCT03543605

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1667 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-12-31

Brief Summary

Background: In nursing homes, excessive and inappropriate use of antimicrobials, adverse events caused by these drugs, and infections by multidrug-resistant bacteria (MDRB) are more frequent than in the general population, posing a serious Public Health risk. Antimicrobial stewardship programs (ASP) are a key strategy to improve the use of antibiotics and to fight against bacterial resistance. Its usefulness in hospitals has been demonstrated. The Centers for Disease Control and Prevention urge the implementation ASP in nursing homes, with measures taken from the ASP in hospitals, but the available information is so limited that it does not allow specific recommendations to be made for these centers.

Objectives: To know if an ASP with an individual intervention measure, the clinical assessments, is better to an ASP with general intervention measures, both designed specifically for nursing homes, and what is the clinical and ecological impact of both, on the baseline situation.

Methods: a) Randomized clinical trial, in parallel groups, for comparison of both ASP. b) Quasi-Experimental study of timeseries for the evaluation of the clinical and ecological impact on the baseline situation. The following indicators will be analyzed: the use of antimicrobials in the centers; the intestinal microbiota diversity of nursing home residents, and the incidence of MDRB and Clostridium difficile infections; and the frequency of adverse events caused by antimicrobials and hospital admissions for infections. The study population will be 2.220 residents from 20 public nursing homes.

Conditions

Human Microbiome; Antibiotic Resistant Infection; Nursing Homes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PROA Experimental

It consists of the intervention measures described in the general antimicrobial stewardship program (PROA Control) plus clinical advice.

• The clinical assessments have been adapted for this project to the unique characteristics of infectious diseases in nursing homes.
• These are individual training activities whose main objective is to modify prescribing behaviors when they are inadequate and reinforce them when they are correct.
• They are carried out between the medical adviser, an expert in infectious diseases, and the doctor of the nursing home, through the structured review of a case attended by the doctor in the last 24 hours. The recommendations are not compulsory, and do not seek to change the decisions made in that patient, but the future ones in the case that is necessary.
• The counseling will be done by video-conference, with an approximate duration of 10 minutes. Each of the doctors will receive two monthly assessments during the intervention period.

Group Type: EXPERIMENTAL

PROA Experimental

Intervention Type: BEHAVIORAL

PROA Control plus clinical advice

PROA Control

The intervention of the general antimicrobial stewardship program (PROA) contains the following set of measures:

• Creation of the local team of the PROA: one of the Family Physicians responsible for the patients and the pharmacist of the reference hospital of the center.
• Presentation of the project by the local team in its own center.
• Choice of the Aljarafe guide as a reference document for the diagnosis and treatment of infectious diseases. It is an accredited guide and widely disseminated among primary care and hospital doctors.
• Permanent information of the project (poster with its synthesis, a pocket triptych with the guide for the clinical management of the main clinical syndromes of infections in the residents of the nursing homes).
• Feedback of the results that will serve each center to know the evolution of its results, and to stimulate the comparison with the other centers.

Group Type: OTHER

PROA Control

Intervention Type: OTHER

PROA Control

Interventions

PROA Experimental

PROA Control plus clinical advice

Intervention Type: BEHAVIORAL

PROA Control

PROA Control

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Public nursing homes under the ownership of the Department of Equality and Social Policies of the Junta de Andalucía

Exclusion Criteria

• Nursing homes that are not under the ownership of the Department of Equality and Social Policies of the Junta de Andalucía

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

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, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Virgen del Rocío University Hospital

Locations

Virgen del Rocío University Hospital

Seville, , Spain

Countries

Spain

References

Penalva G, Crespo-Rivas JC, Guisado-Gil AB, Rodriguez-Villodres A, Pachon-Ibanez ME, Cachero-Alba B, Rivas-Romero B, Gil-Moreno J, Galva-Borras MI, Garcia-Moreno M, Salamanca-Bautista MD, Martinez-Rascon MB, Cantudo-Cuenca MR, Ninahuaman-Poma RC, Enrique-Miron MLA, Perez-Barroso A, Marin-Ariza I, Gonzalez-Florido M, Mora-Santiago MDR, Belda-Rustarazo S, Exposito-Tirado JA, Rosso-Fernandez CM, Gil-Navarro MV, Lepe-Jimenez JA, Cisneros JM; PROA-SENIOR Study Group. Clinical and Ecological Impact of an Educational Program to Optimize Antibiotic Treatments in Nursing Homes (PROA-SENIOR): A Cluster, Randomized, Controlled Trial and Interrupted Time-Series Analysis. Clin Infect Dis. 2023 Mar 4;76(5):824-832. doi: 10.1093/cid/ciac834.

Reference Type: DERIVED

PMID: 36268822 (View on PubMed)

Other Identifiers

PROA-SENIOR (PRO-FIS-2017-01)

Identifier Type: -

Identifier Source: org_study_id