Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 643 for:    test AND point-of-care

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03855215
Recruitment Status : Not yet recruiting
First Posted : February 26, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
National Hospital for Tropical Diseases, Hanoi, Vietnam
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Infection Diagnostic Test: ACTIM CRP Rapid Test (Medix, Biochemica) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementation of CRP Point of Care Testing in Primary Care to Improve Antibiotic Targeting in Respiratory Illness (ICAT)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Intervention

The ACTIM CRP Rapid Test (Medix, Biochemica) will be made available to the healthcare workers at the CHCs for use in patients in the target population.

Printed guidance will be issued for the performance and interpretation of the CRP test results in terms of antibiotic guided treatment. The treating healthcare worker will decide based on their clinical evaluation whether or not to comply with this guideline. This guidance will also be discussed during the training sessions.

The healthcare workers are recommended to use the CRP tests in all patients meeting the target population. The CRP cut-offs will be recommended below in the absence of warning signs of severity:

CRP level < 10 mg/L: no antibiotics are recommended CRP level from 10 mg/L to 40 mg/L: antibiotics are unlikely to be needed but should be considered in cases of high clinical concern CRP level > 40 mg/L: antibiotics are recommended.

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.

No Intervention: Control
Working as routine



Primary Outcome Measures :
  1. Proportion of patients aged 1 to 65 years, consulting for ARI, who are prescribed antibiotics in the two study arms [ Time Frame: Through study completion, the proportion of 1 year ]

Secondary Outcome Measures :
  1. The proportion of patients that consulted with ARI in the preceding year. [ Time Frame: Before the 1st recruitment ]
  2. Prescription rates for ARI patients in the preceding year. [ Time Frame: Before the 1st recruitment ]
  3. Proportion of patients indicated CRP test according to diagnosis, age, gender [ Time Frame: Through study completion, the data of 1 year ]
  4. Proportion of patients prescribed an antibiotic in the intervention arm with: a. CRP < 10 mg/L b. CRP from 10mg/L to 40mg/L c. CRP > 40mg/L [ Time Frame: Through study completion, the proportion of 1 year ]
  5. Proportion of patients receiving an antibiotic with the denominator being: a. All attendances b. All non-routine attendances [ Time Frame: Through study completion, the proportion of 1 year ]
  6. Proportion of patients receiving an antibiotic prescription by diagnosis, age, season, recorded fever, sex [ Time Frame: Through study completion, the proportion of 1 year ]
  7. The proportion of patients referred to a higher level facility at the initial consultation by checking the e-database of health insurance (HI) reimbursement [ Time Frame: Through study completion, the proportion of 1 year ]
  8. Proportion of patients in whom the test is indicated who re-attend the health facility within a 30 days period, and whether antibiotics were prescribed comparing intervention CHCs and controls [ Time Frame: Through study completion, the proportion of 1 year ]
  9. Proportion of patients in whom the test is indicated hospitalised within a 30 day period (excluding patients referred at consultation) [ Time Frame: 30 days after the last recruitment ]
  10. Qualitatively measure the usability and acceptability of CRP test among healthcare workers [ Time Frame: After finishing the recruitment, organize the structured interviews, ask about 1 year of study implementation ]
    Structured interviews will be conducted with the healthcare workers in both the intervention and control arms at the end of the study for their views on antibiotic use and AMR. Healthcare workers in the intervention arm will also be asked whether the test was usable and useful and whether they support their continued use

  11. Measure of cost-effectiveness [ Time Frame: Through study completion, estimate the cost-effectiveness of the intervention for 1 year ]
    A cost analysis will be carried out to assess the budget implications for introducing the tests, accounting for the cost of treatments and referrals, and a cost-benefit analysis will compare any incremental costs with the modelled costs of AMR averted

  12. the proportion of patients in whom use of the test was recommended that received the test. [ Time Frame: Through study completion, the proportion of 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged from 1 to under 65 years old
  • First consultation with an acute respiratory infection diagnosed by the healthcare worker with at least 1 focal sign or symptom*
  • Symptoms lasting less than 7 days * Focal signs and symptoms: (1) cough, (2) rhinitis (sneezing, nasal congestion, or runny nose), (3) pharyngitis (sore throat), (4) shortness of breath, (5) wheezing, (6) chest pain, or (7) auscultation abnormalities.

Exclusion Criteria:

  • Patients requiring referral to a higher level facility based on the healthcare worker's clinical assessment
  • immunosuppressed patients (known HIV, long term steroid use)
  • those with a suspicion of tuberculosis or a non-respiratory tract illness

Additional Information:
Publications:
WHO. Integrated Management of Childhood Illness. Geneva, Switzerland; 2014
The World Health Organization. Integrated management of adolescent and adult illness: interim guidelines for first-level facility health workers at health centre and district outpatient clinic: acute care. 2009; Rev 3

Layout table for additonal information
Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT03855215     History of Changes
Other Study ID Numbers: 31HN
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oxford University Clinical Research Unit, Vietnam:
acute respiratory infection
ARI
antibiotic
Antimicrobial resistance
AMR
primary health care
CRP

Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents