NCT03715062

Brief Summary

This cluster randomized controlled study evaluates the effect of a tailored observation, reflection and communication tool on used by long-term care facility staff on antibiotic prescription for urinary tract infection in long-term care facility residents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,491

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

June 4, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

October 5, 2018

Last Update Submit

May 31, 2019

Conditions

Keywords

Long-term care facilityISBARCommunicationAntibioticsAntibiotic stewardship

Outcome Measures

Primary Outcomes (1)

  • Prescription of antibiotics for urinary tract infection

    The number of antibiotic prescriptions for urinary tract infections pr resident days

    17 weeks

Secondary Outcomes (3)

  • Hospitalization

    17 weeks

  • Death

    17 weeks

  • Appropriate prescription of antibiotics for urinary tract infections

    17 weeks

Other Outcomes (3)

  • Symptoms

    17 weeks

  • Observations

    17 weeks

  • Contact to doctor

    17 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Receives education in diagnosing urinary tract infection and use of observation, reflection and communication tool.

Other: Dialogue tool

Control group

NO INTERVENTION

No intervention

Interventions

The intervention has two parts: an educational session and a dialogue tool. The educational session consists of 75 minutes of education in diagnosing urinary tract infection. The dialogue tool consists of 1) a checking box for the most important symptoms and observations for urinary tract infection 2) an algorithm to evaluate if urinary tract infection is likely based on the present symptoms and observations 3) a list of reflection points to evaluate with a collegue 4) a specialized ISBAR (communication tool) if long-term care facility staff finds it appropriate to contact the General Practicioner

Also known as: Observation, reflection and communication tool
Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • We include only social and health helpers, social and health assistants and nurses, who have a permanent contract at the LTCF and do day- or evening shifts for the educational session. It is optional for the LTCF to use the educational material to educate LTCF staff in nightshifts. However, a UTI is rarely observed and reported during the night, which is why we chose this pragmatic approach. Usually, if a UTI is suspected, the night shift will report to the day shift, who then reevaluates and contacts the GP if necessary. We also target the permanently employed, as they are the majority of employees with nursing responsibilities and set the standard for the temporary staff.
  • All incidents of suspected UTI in LTCF residents or antibiotic prescriptions for UTI must be registered. All registrations must be made on LTCF residents above 65 years of age and with a permanent address at the LTCF, otherwise the incidence of ASB is different than assumed in preparing the intervention.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit of General Practice

Copenhagen, 1014, Denmark

Location

Related Publications (2)

  • Arnold SH, Nygaard Jensen J, Bjerrum L, Siersma V, Winther Bang C, Brostrom Kousgaard M, Holm A. Effectiveness of a tailored intervention to reduce antibiotics for urinary tract infections in nursing home residents: a cluster, randomised controlled trial. Lancet Infect Dis. 2021 Nov;21(11):1549-1556. doi: 10.1016/S1473-3099(21)00001-3. Epub 2021 Jul 22.

  • Arnold SH, Jensen JN, Kousgaard MB, Siersma V, Bjerrum L, Holm A. Reducing Antibiotic Prescriptions for Urinary Tract Infection in Nursing Homes Using a Complex Tailored Intervention Targeting Nursing Home Staff: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2020 May 8;9(5):e17710. doi: 10.2196/17710.

MeSH Terms

Conditions

Urinary Tract InfectionsCommunication

Interventions

Observation

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavior

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Lars Bjerrum, MD, PHD

    Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Statistical analysis is masked.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled study, where each Long-term care facility is one cluster.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 22, 2018

Study Start

December 1, 2018

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

June 4, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations