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Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dialogue tool
Sponsored by
Research Unit Of General Practice, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Urinary Tract Infections focused on measuring Long-term care facility, ISBAR, Communication, Antibiotics, Antibiotic stewardship

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • LTCFs eligible for inclusion have common service areas with attending staff 24 hours a day and they cannot be specialized i.e. not psychiatric LTCFs or LTCFs for the blind, except for LTCFs specialized in dementia. The residents living in these types of facilities requires a level of care that typically ensures that the LTCF staff handles all contact with the GP on behalf of the resident, while the LTCF residents remains a somewhat homogenous group.
  • 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.

Exclusion Criteria:

  • None

Sites / Locations

  • Research Unit of General Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hospitalization
The number of hospitalizations caused by urinary tract infections pr resident days
Death
The number of deaths caused by urinary tract infections pr resident days
Appropriate prescription of antibiotics for urinary tract infections
The number of treatments with adequate symptoms and observations for treatment pr resident days

Full Information

First Posted
October 5, 2018
Last Updated
May 31, 2019
Sponsor
Research Unit Of General Practice, Copenhagen
Collaborators
Ministry of the Interior and Health, Denmark, Velux Fonden, Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03715062
Brief Title
Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities
Official Title
Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities With a Complex Intervention Targeted at Nursing Home Staff -A Protocol for a Cluster Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Unit Of General Practice, Copenhagen
Collaborators
Ministry of the Interior and Health, Denmark, Velux Fonden, Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Healthcare-associated infections due to antimicrobial use in long-term care facilities (LTCF) is an increasing problem in europe. It is well established that there exists a positive correlation between the amount of antibiotics used in treatment and resistant bacteria in both individual patients and society as a whole. A point-prevalence audit from 2017 in LTCFs showed that 10.5% of all LTCF residents in Denmark are treated with an antibiotic agent. In 78% of the cases, the cause for treatment was urinary tract infection (UTI). In addition, this group of elderly are particularly vulnerable to healthcare-associated infections, drug interactions and adverse effects. Thus, there are persuasive reasons for reducing antibiotic use in this specific group. In the diagnostic process for UTI in a LTCF resident, there are several non-clinical factors influencing the diagnosis and leading to unnecessary treatment. First, because of dementia, sequelae from apoplexies, difficulties walking and other ailments, the typical LTCF resident is unable to express symptoms clearly and attend the GPs office. Consequently, the diagnosis is based on observations made by LTCF staff, which are then communicated to the General Practitioner (GP). Second, the prevalence of asymptomatic bacteriuria is up to 50% in this particular group. Though several studies have found that asymptomatic bacteriuria is a benign condition, it continues to be treated. Third, unspecific symptoms such as mental status change, falls or decreased function are unlikely to be caused by UTI. However, unspecific symptoms are still driving diagnosis and treatment of UTI. These factors may influence diagnosis and treatment in the Danish LTCF setting and therefore, a significant portion of the prescribed antibiotics for UTI could be due to overtreatment. There is some evidence suggesting that antibiotic stewardship programs focusing on education of LTCF staff decreases antibiotic prescriptions and increases adherence to guidelines. In addition, there is moderate evidence that the widely used communication tool ISBAR (Identification, Situation, Background, Analysis, Recommendation) improves patient safety by improving interprofessional communication especially when communicating over the phone. Thus, if LTCF staff were educated on relevant observation, how to approach ASB, unspecific symptoms and structured handover of clinical information, the impact of these factors on diagnosis and treatment of UTI in LTCF residents may decrease. Overall, antibiotic stewardship programs in LTCF are somewhat effective. However, most of these were targeted at prescribers only or prescribers and nurses and some were also prone to bias because of the choice of study design. At present, there exists no cluster Randomized Controlled Trials (cRCT) targeting only LTCF staff with nursing tasks through a combined education- and communication-centered intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Long-term care facility, ISBAR, Communication, Antibiotics, Antibiotic stewardship

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled study, where each Long-term care facility is one cluster.
Masking
None (Open Label)
Masking Description
Statistical analysis is masked.
Allocation
Randomized
Enrollment
1491 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Receives education in diagnosing urinary tract infection and use of observation, reflection and communication tool.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Dialogue tool
Other Intervention Name(s)
Observation, reflection and communication tool
Intervention Description
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
Primary Outcome Measure Information:
Title
Prescription of antibiotics for urinary tract infection
Description
The number of antibiotic prescriptions for urinary tract infections pr resident days
Time Frame
17 weeks
Secondary Outcome Measure Information:
Title
Hospitalization
Description
The number of hospitalizations caused by urinary tract infections pr resident days
Time Frame
17 weeks
Title
Death
Description
The number of deaths caused by urinary tract infections pr resident days
Time Frame
17 weeks
Title
Appropriate prescription of antibiotics for urinary tract infections
Description
The number of treatments with adequate symptoms and observations for treatment pr resident days
Time Frame
17 weeks
Other Pre-specified Outcome Measures:
Title
Symptoms
Description
The number of symptoms observed in each arm
Time Frame
17 weeks
Title
Observations
Description
The number of observations observed in each arm
Time Frame
17 weeks
Title
Contact to doctor
Description
Number of times the doctor was contacted pr resident
Time Frame
17 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: LTCFs eligible for inclusion have common service areas with attending staff 24 hours a day and they cannot be specialized i.e. not psychiatric LTCFs or LTCFs for the blind, except for LTCFs specialized in dementia. The residents living in these types of facilities requires a level of care that typically ensures that the LTCF staff handles all contact with the GP on behalf of the resident, while the LTCF residents remains a somewhat homogenous group. 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. Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Bjerrum, MD, PHD
Organizational Affiliation
Professor
Official's Role
Study Chair
Facility Information:
Facility Name
Research Unit of General Practice
City
Copenhagen
ZIP/Postal Code
1014
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34303417
Citation
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.
Results Reference
derived
PubMed Identifier
32383679
Citation
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.
Results Reference
derived

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Reducing Antibiotic Prescriptions for Urinary Tract Infection in Long-Term Care Facilities

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