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

Urinary Tract Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03715062
• Other study ID #: 111
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: May 2019
• Source: Research Unit Of General Practice, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1491
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Other:
• Dialogue tool
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

Locations

Country	Name	City	State
Denmark	Research Unit of General Practice	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Research Unit Of General Practice, Copenhagen	Herlev Hospital, Ministry of the Interior and Health, Denmark, Velux Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptoms	The number of symptoms observed in each arm	17 weeks
Other	Observations	The number of observations observed in each arm	17 weeks
Other	Contact to doctor	Number of times the doctor was contacted pr resident	17 weeks
Primary	Prescription of antibiotics for urinary tract infection	The number of antibiotic prescriptions for urinary tract infections pr resident days	17 weeks
Secondary	Hospitalization	The number of hospitalizations caused by urinary tract infections pr resident days	17 weeks
Secondary	Death	The number of deaths caused by urinary tract infections pr resident days	17 weeks
Secondary	Appropriate prescription of antibiotics for urinary tract infections	The number of treatments with adequate symptoms and observations for treatment pr resident days	17 weeks