Impact of a Multi-modal Multi-professional Intervention on the Nurse on Antibiotics Prescribing in EHPAD Retirement Home

Antibiotics Prescribed in EHPAD Retirement Home in Front of Suspition of Urinary Infection Clinical Trial

— ATOUM6  

Official title:

Study 6 Impacts of a Multi-modal Multi-professional Intervention on the Nurse on Antibiotics Prescribing in EHPAD Retirement Home: a Randomized Study in Cluster.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03994523
• Other study ID #: 2018-A03248-47
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 2020

Study information

• Verified date: June 2019
• Source: Gérond'if
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure the impact of a multimodal intervention through the nurse in relation to prescribers, residents and their families, on antibiotics prescribing for urinary infection in EHPAD Retirement Home

Description:

This is a randomized, cluster, two-arm intervention study in 40 EHPAD Retirement Home in Ile-de-France.

EHPADs Retirement Homes selected for the random draw study will be randomized either to intervention arm or to control arm. Each time an EHPAD Retirement Home assigned to control arm is less than 10 km from another intervention arm and vice versa.

This study will consist of four main parts. On the one hand, it will be the inclusion phase of participating centres prior to the start of the implementation of the intervention. THis step is planned for one and half months. On the other hand, it is a question to test an initial intervention for adjustment if necessary for 15 days.

Intervention period will include a period of visits to EHPAD Retirement Home with a phone follow-up, this phase will last 6 months.

EHPADs Retirement Homes will be invited to build tools to complement those made available by the research team through an inter-EHPAD Retirement Home of intervention arm. This competition will start 2 months after the collection phase; that is during the follow-up and is planned to last 4 months. A further 6 month phase without an EHPAD Retirement Home visit will then be implemented to observe the autonomy of centres to appropriate and use tools. The collection of post-intervention data will take place within one month; that's a period of thirteen months for monitoring and data collection.

The intervention will focus on strengthening the nurse's theoretical knowledge, with online training, and on the other hand, telephone interviews associated with the reinforcement of his clinical reasoning through a flowchart of clinical decision support (decision tree). Another aspect of this intervention will be the strengthening of physician-nurse communication tools in the relevant EHPADs Retirement Home through the Situation-Background-Assessment-Recommendation (SBAR).

There are three key moments in the response in addition to the EHPAD Retirement Home call-back visits:

• Dematerialized training through access to training tools followed by self-assessments. These tools will focus on antibiotic therapy, urinary tract infection and communication with nursing physicians.

• A competition between the EHPADs Retirement Home of intervention arm

• The implementation of this intervention, a pre-test will be carried out in two randomly selected EHPADs Retirement Home which will agree to participate. It will be used to correct any deficiencies before the actual implementation. Two EHPADs Retirement Home selected will not be part of the final intervention.

During this study, the following data will be collected by questionnaires: EHPAD Retirement Home data, infection information, prescription counts and overall consumption per class of antibiotics, evaluation of the use of information and training tools in EHPADs Retirement Home of intervention arm (process audit), and improvement of nurses' knowledge (results audit), all data that will contribute to the medico-economic analysis of the intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• EHPAD Retirement Home

• Having nursing staff

• Presence of a drug prescription registration system

• EHPAD Retirement Home not attached to hospital

Exclusion Criteria:

• No EHPAD Retirement Home

• Absence of a drug prescription registration system

• EHPAD Retirement Home attached to hospital

Related Conditions & MeSH terms

• Antibiotics Prescribed in EHPAD Retirement Home in Front of Suspition of Urinary Infection
• Urinary Tract Infections

Intervention

Other:
• Intervention
The intervention will focus on strengthening the nurse's theoretical knowledge, with online training, and on the other hand, telephone interviews associated with the reinforcement of his clinical reasoning through a flowchart of clinical decision support (decision tree). Another aspect of this intervention will be the strengthening of physician-nurse communication tools in the relevant EHPADs Retirement Home through the Situation-Background-Assessment-Recommendation (SBAR).

Locations

Country	Name	City	State
France	University Paris 13 - LEPS Laboratory	Bobigny	Ile-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Gérond'if	University of Paris 13

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of relative frequency of antibiotic prescriptions for urinary tract infection		18 months
Secondary	Measure the impact on the overall prescription of antibiotics as a result of the intervention	Percentage of antibiotic prescription regardless of diagnosis and reason for prescription.	18 months
Secondary	Measure the impact on the overall volume of antibiotics from the intervention	The overall volume of antibiotics consumed and expressed in defined daily dose during the 12 months following the period of the first EHPAD Retirement Home visits.	12 months
Secondary	Measuring the budgetary impact of this assistance	Estimate the budgetary impact of the intervention from the point of view of the EHPAD Retirement Home	18 months