Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly (ImpresU-WP2)

Cees Hertogh

Status: Completed

Conditions: Urinary Tract Infections

Treatments: Other: antibiotic stewardship intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03970356

2017/25/Z/NZ7/03024 (Other Grant/Funding Number)

2005035

2017-05975 (Other Grant/Funding Number)

25 (2017) (Other Grant/Funding Number)

549003002 (Other Grant/Funding Number)

284253 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to determine whether a tailored multifaceted antibiotic stewardship intervention reduces antibiotic use for urinary tract infections in residential care homes and nursing homes attended by general practitioners. This will be evaluated in a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach.

Full description

Rationale:

Almost 60% of antibiotics in frail elderly is prescribed for alleged UTI. About half of the antibiotics for UTI in this population are prescribed for non-specific signs and symptoms; a substantial part of these prescriptions might not be necessary.

Research question:

Does a tailored multifaceted antibiotic stewardship intervention reduce antibiotic use for UTI in residential care homes and nursing homes attended by general practitioners (GPs)?

Study design, setting and population:

A pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach. In the intervention group the latest UTI guidelines (which are standard care) are actively implemented at the level of the GP/caregivers. Residents ≥ 70 year with ADL dependency from 34 care homes + attending GP practices will participate in Norway, Sweden, Poland and the Netherlands.

Methods:

The study has two measurement periods; a baseline period (5 months) and a follow-up period (7 months). In between the antibiotic stewardship intervention will be tailored and implemented in intervention practices. GPs will prospectively register suspected UTIs on standardized registration forms and (study) nurses/assistants will follow-up patients at day 7 and day 21 for each UTI.

Patients will be enrolled prior to the start of the study.

• June-August 2019: patient are recruited, informed consent is obtained, baseline characteristics of patients are recorded
• Sept 2019: study starts (from this moment onwards, the outcomes are being assessed).

Data analysis:

The primary analysis will be to assess the number of prescriptions of antibiotics for suspected UTI in the follow-up period, correcting for the baseline period and controlled for pre-specified confounders, using a generalized linear mixed model for Poisson distributions.

Enrollment: 1,146 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• physical and/or mental disabilities and ADL dependency requiring residential care or nursing home care
• attended by general practitioners
• not on continuous prophylactic antibiotic use

Exclusion criteria

• in hospice-care
• very limited life expectancy (≤1 month)
• no longer wish to participate
• start continuous antibiotic (prophylaxis)
• die or move away from the residential care home / nursing home

If patients are excluded within 2 months after inclusion, they will be taken out of the study. In other words: patients need to be included for at least 2 months to contribute data to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,146 participants in 2 patient groups

intervention

Experimental group

Description:

The antibiotic stewardship intervention will encourage to prescribe according to the latest relevant UTI guidelines which promote more restrictive use of antibiotics in case of non-specific symptoms.

Treatment:

Other: antibiotic stewardship intervention

control

No Intervention group

Description:

Usual care