NCT03180983

Brief Summary

CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses who alert prescribers when an infection is suspected by describing clinical signs.However, his propensity to perform too rapidly and systematically an examination with dipsticks leads the physician to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program. OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

June 1, 2017

Last Update Submit

January 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Antibiotics prescription for UTI

    The percentage of reduction in prescriptions of antibiotics for urinary tract infection

    Twelve months

Secondary Outcomes (1)

  • Total prescriptions of antibiotics

    Twelve months

Study Arms (2)

INTERVENTIONAL GROUP

OTHER

The intervention group will receive a blended-learning intervention.

Behavioral: multimodal intervention

CONTROL GROUP

NO INTERVENTION

No intervention

Interventions

Investigators will propose an online training. In addition, investigators will make phone calls to nursing home interlocutor between two nursing home visits. The tools of this intervention will consist on posters , quiz about bacteriuria and urinary tract infection (UTI) and algorithm to help nurse's reasoning when UTI is suspected.

INTERVENTIONAL GROUP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nursing home with registred nursing
  • Presence of prescription registration system
  • Situated in Paris and surb of Paris

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Franchi C, Tettamanti M, Pasina L, Djignefa CD, Fortino I, Bortolotti A, Merlino L, Nobili A. Changes in drug prescribing to Italian community-dwelling elderly people: the EPIFARM-Elderly Project 2000-2010. Eur J Clin Pharmacol. 2014 Apr;70(4):437-43. doi: 10.1007/s00228-013-1621-6. Epub 2014 Jan 8.

    PMID: 24398968BACKGROUND
  • Moreira VG, Lourenco RA. Prevalence and factors associated with frailty in an older population from the city of Rio de Janeiro, Brazil: the FIBRA-RJ Study. Clinics (Sao Paulo). 2013 Jul;68(7):979-85. doi: 10.6061/clinics/2013(07)15.

    PMID: 23917663BACKGROUND
  • Smith PW, Bennett G, Bradley S, Drinka P, Lautenbach E, Marx J, Mody L, Nicolle L, Stevenson K; Society for Healthcare Epidemiology of America (SHEA); Association for Professionals in Infection Control and Epidemiology (APIC). SHEA/APIC Guideline: Infection prevention and control in the long-term care facility. Am J Infect Control. 2008 Sep;36(7):504-35. doi: 10.1016/j.ajic.2008.06.001. No abstract available.

    PMID: 18786461BACKGROUND
  • Smith PW, Bennett G, Bradley S, Drinka P, Lautenbach E, Marx J, Mody L, Nicolle L, Stevenson K; SHEA; APIC. SHEA/APIC guideline: infection prevention and control in the long-term care facility, July 2008. Infect Control Hosp Epidemiol. 2008 Sep;29(9):785-814. doi: 10.1086/592416. No abstract available.

    PMID: 18767983BACKGROUND
  • Marston HD, Dixon DM, Knisely JM, Palmore TN, Fauci AS. Antimicrobial Resistance. JAMA. 2016 Sep 20;316(11):1193-1204. doi: 10.1001/jama.2016.11764.

    PMID: 27654605BACKGROUND
  • Phillips CD, Adepoju O, Stone N, Moudouni DK, Nwaiwu O, Zhao H, Frentzel E, Mehr D, Garfinkel S. Asymptomatic bacteriuria, antibiotic use, and suspected urinary tract infections in four nursing homes. BMC Geriatr. 2012 Nov 23;12:73. doi: 10.1186/1471-2318-12-73.

    PMID: 23176555BACKGROUND
  • Chami K, Gavazzi G, Carrat F, de Wazieres B, Lejeune B, Piette F, Rothan-Tondeur M. Burden of infections among 44,869 elderly in nursing homes: a cross-sectional cluster nationwide survey. J Hosp Infect. 2011 Nov;79(3):254-9. doi: 10.1016/j.jhin.2011.08.003. Epub 2011 Sep 6.

    PMID: 21899920BACKGROUND
  • Inkster T, Marek A, Khanna N. Improving antimicrobial prescribing by targeting clinical nurse practitioners. J Hosp Infect. 2010 Sep;76(1):85-6. doi: 10.1016/j.jhin.2010.05.009. No abstract available.

    PMID: 20663586BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: CLUSTER RANDOMIZED STUDY
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of nursing research chair

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 8, 2017

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 30, 2020

Last Updated

January 8, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share