Implementation of CRP Point of Care Testing in Primary Care to Improve Antibiotic Targeting in Respiratory Illness (ICAT)

Summary

The proposed study will monitor and evaluate a quality improvement project - the introduction of commercially available lateral flow CRP tests with international regulatory approval, as a routine care service to improve the management of patients with acute respiratory infection (ARI) and reduce unnecessary antibiotic prescribing. No research staff will be present, and to minimise disruption and alteration of routine care, a waiver of written patient informed consent will be requested from the relevant ethical review boards, in accordance with the 2016 WHO/CIOMS International Guidance for Health-related Research Involving Humans8. Instead, patients in intervention clusters will be provided with information concerning how the test can assist healthcare workers in identifying when antibiotics are required, after which they will be free to refuse its use.

The test selected for use in the study is the Actim® CRP test from Medix Biochemica (Finland; ISO certification ISO13485:2016). The test is a simple lateral flow device that uses capillary blood, obtained through a finger/heel puncture. The test provides a semi-quantitative indication of whether CRP concentrations are \<10mg/L, between 10-40mg/L, between 40-80mg/L, or above 80mg/L, in under 5 minutes with minimal training requirements. The test has been approved by the European regulatory body (CE-marking) as well as in 13 other countries around the world (including Switzerland, Norway, Iceland, Israel and Thailand) and has been validated for accuracy in previous publications.9,10 Our own research group has also confirmed the tests' accuracy in both laboratory and field environments, including their thermos-stability in a tropical climate (see annex). Neither Medix Biochemica nor any of its distributors, have had involvement with the design of the evaluation and our group has no conflict of interest with respect to the choice of the test.

Main research question: Can point of care CRP tests introduced in routine primary healthcare reduce prescription of antibiotics for patients with acute respiratory infections, outside of the research context?

Brief description of the intervention: The implementation of CRP point of care tests will be conducted at commune health centres (CHCs), the primary access point for public health services in Vietnam (CHC details are described in the Location section below). Prior to introduction of the tests, an educational session will be provided for local healthcare workers in both intervention and control arms about the role of antibiotics and AMR. After randomization, further training will be provided for healthcare workers in the intervention CHCs as to the use of CRP testing to guide antibiotic prescribing decisions. In the intervention CHCs, healthcare workers will be trained on the use and interpretation of CRP testing in ARI (detailed in section 5.4). Educational materials will also be developed for patients and care-givers regarding the value of CRP testing.

Description of the population to be studied: This study will be conducted in the general population of Nam Dinh, a rural province in northern Vietnam. The test will be provided at CHCs and recommended for use in patients presenting with a chief complaint of ARI.

Conditions

• Acute Respiratory Infection

Interventions

DIAGNOSTIC_TEST

ACTIM CRP Rapid Test (Medix, Biochemica)

The implementation of CRP point of care tests will be conducted at commune health centres (CHCs), the primary access point for public health services in Vietnam. In the intervention CHCs, healthcare workers will be trained on the use and interpretation of CRP testing in ARI. healthcare workers can decide to follow the test results or not.

Sponsors & Collaborators

• National Hospital for Tropical Diseases, Hanoi, Vietnam

  collaborator OTHER_GOV

• Oxford University Clinical Research Unit, Vietnam

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-01

Primary Completion

2021-06-01

Completion

2021-06-01

Countries

• Vietnam

Study Locations