Antibiotic prescribing habits in children with infections in primary care in Latvia and the effect of a multifactorial intervention (family physician education and C reactive protein point-of-care testing) on a change of habits
| ISRCTN | ISRCTN34931655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34931655 |
| Secondary identifying numbers | 6-3/5/21 |
- Submission date
- 11/05/2024
- Registration date
- 15/07/2024
- Last edited
- 15/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Acute infection in children is one of the most common reasons for attending family physicians (FPs) and these visits often result in antibiotic prescriptions. As self-limiting viral infections are predominant, at least 30% of antibiotics prescribed in outpatient settings are considered to be unnecessary. The aim of this study is to evaluate the effect of the combination of two interventions – access to C reactive protein (CRP) point-of-care testing in FPs’ practices and educational training for FPs – on the antibiotic prescribing rate for acutely ill children.
Who can participate?
Child-age patients (1 month up to 17 years) with acute infections visiting FPs in face-to-face consultations
What does the study involve?
80 FPs were divided into two groups of 40 FPs: Group 1 and Group 2. In the first period, the FPs in Group 1 received two interventions (CRP POCT and a live educational session) and Group 2 continued usual care as a control without any interventions. In the second study period, FPs were switched - Group 2 received both interventions (CRP testing and a live educational session) and Group 1 continued usual care without CRP testing anymore.
The 4-hour live educational session included principles of antibiotic resistance and safer prescribing of antibiotics, as well as new recommendations for the management of respiratory infections and fever in children introduced in 2019 in Latvia. FPs also received educational material in video and printed format after the session.
FPs were given a system for measuring CRP in blood obtained via a finger prick. Each FP was individually tutored by the diagnostic test company on how to perform the CRP test during a face-to-face meeting, and ongoing support by the company was available to the FP during the intervention period. FPs ordered a CRP test only if they believed the result would help them make a more informed decision on antibiotic necessity after a clinical assessment.
What are the possible benefits and risks of participating?
There were no risks for patients because FPs ordered a CRP test only if they believed the result would help them make a more informed decision on antibiotic necessity after a clinical assessment not for all patients. As CRP point-of-care testing is not incorporated into Latvian primary care, it provided the opportunity to get new experience with CRP testing in daily practice. Also, FPs were introduced to the new clinical pathways and guidelines.
Where is the study run from?
Riga Stradins University (Latvia)
When is the study starting and how long is it expected to run for?
February 2019 to May 2021
Who is funding the study?
Riga Stradins University (Latvia)
Who is the main contact?
Zane Likopa, zane.likopa@bkus.lv
Contact information
Public, Scientific
Kaktusu 3
Riga
LV 1024
Latvia
 ORCID ID |
0000-0002-7048-9783 |
|---|---|
| Phone | +371 (0)29482308 |
| zane.likopa@bkus.lv |
Principal Investigator
Vienibas gatve 45
Riga
LV-1004
Latvia
| ORCID ID |
0000-0001-8469-4713 |
|---|---|
| Phone | +371 (0)29482308 |
| jana.pavare@rsu.lv |
Study information
| Study design | Randomized controlled intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Diagnostic, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effect of combination of point-of-care C-reactive protein testing and family physician education on reducing antibiotic prescribing for children presenting with acute infections in primary care in Latvia: a randomised controlled intervention study |
| Study objectives | A combined intervention – family physician education and C reactive protein point-of-care testing – will reduce the frequency of prescription for antibiotics in children with infections in primary care. |
| Ethics approval(s) |
Approved 30/05/2019, Research Ethics Committee of Riga Stradins University (Dzirciema street 16, Riga, LV - 1007, Latvia; +371 (0)29482308; pek@rsu.lv), ref: 6-3/5/21 |
| Health condition(s) or problem(s) studied | Reducing antibiotic prescribing for children with acute infections |
| Intervention | This was a randomized controlled intervention study, with randomization at the family physician (FP) practice level. The FPs were stratified according to practice location, and each stratum was divided into two groups of 40 FPs using random numbers generated by MS Excel Random Number function. The effect of the combination of two interventions, a live educational session and C reactive protein point-of-care testing (CRP POCT), was evaluated. 80 FPs were divided into two groups of 40 FPs – Group 1 and Group 2. In the first period, the FPs in Group 1 received two interventions (CRP POCT and a live educational session) and Group 2 continued usual care as a control without any interventions. In the second study period FPs were switched - Group 2 received both interventions (CRP POCT and a live educational session) and Group 1 continued usual care without CRP POCT anymore. The 4-hour live educational session included principles of antibiotic resistance and safer prescribing of antibiotics, as well as new recommendations for the management of respiratory infections and fever in children introduced in 2019 in Latvia. FPs also received educational material in video and printed format after the session. FPs were given the Orion Diagnostica QuikRead go CRP POCT system for the quantitative determination of CRP in blood with a sample volume of 20 µl obtained via a finger prick. This system has a measuring range of 5–200 mg/L and the result is available within 2 minutes. As CRP cut-off levels for children in primary care are currently undetermined, the FPs did not receive any guidelines on the interpretation of results. Each FP was individually tutored by the diagnostic test company on how to perform the CRP test during a face-to-face meeting, and ongoing support by the company was available to the FP during the intervention period. FPs ordered a CRP test only if they believed the result would help them make a more informed decision on antibiotic necessity after a clinical assessment. |
| Intervention type | Mixed |
| Primary outcome measure | Antibiotic prescribing at the index consultation for patients with acute illnesses with symptoms less than 5 days visiting FP in face-to-face consultations, measured using dichotomous variables - prescribed, not prescribed |
| Secondary outcome measures | CRP testing frequency measured using continuous variable - number of tests performed and CRP level measured with Orion Diagnostica QuikRead go CRP POCT system during index consultation using four categories (<20 mg/L; 20.1 mg/L - 50.0 mg/L; 50.1 mg/L - 99.0 mg/L, >100 mg/L) |
| Overall study start date | 01/02/2019 |
| Completion date | 01/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 2284 (571 in each group) |
| Total final enrolment | 3801 |
| Key inclusion criteria | 1. Current clinical signs of acute infection for less than 5 days 2. Aged 1 month up to 17 years old |
| Key exclusion criteria | 1. Age under 1 month 2. Re-convalescent stage of infectious disease 3. Use of antimicrobial therapy before the time of the visit |
| Date of first enrolment | 15/11/2019 |
| Date of final enrolment | 30/04/2021 |
Locations
Countries of recruitment
- Latvia
Study participating centre
Latvia
Sponsor information
University/education
Dzirciema 16
Riga
LV-1007
Latvia
| Phone | +371 (0)67 409 219 |
|---|---|
| rsu@rsu.lv | |
| Website | http://www.rsu.lv/eng/ |
"ROR" |
https://ror.org/03nadks56 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- Rīga Stradiņš University, Rīga Stradiņš University, Universitas Rigensis Stradina, Riga Medical Institute, Medical Academy of Latvia, RSU
- Location
- Latvia
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study results are going to be published in four following publications: 1. Antibiotic prescribing habits – published 2021 Likopa, Z., Kivite-Urtane, A. and Pavare, J. 2021. Latvian Primary Care Management of Children with Acute Infections: Antibiotic-Prescribing Habits and Diagnostic Process Prior to Treatment. Medicina (B. Aires)., 57. doi: 10.3390/MEDICINA57080831. 2. The first study period results - published 2021 Likopa, Z., Kivite-Urtane, A., Silina, V. and Pavare, J. 2021. Impact of educational training and C-reactive protein point-of-care testing on antibiotic prescribing in rural and urban family physician practices in Latvia: a randomised controlled intervention study. doi: 10.1186/s12887-022-03608-4. 3. Overall results of the study - planned to be published in May 2024 Likopa, Z., Kivite-Urtane, A. and Pavare. Effect of combination of point-of-care C-reactive protein testing and family physician education and long-term effect of education on reducing antibiotic prescribing for children presenting with acute infections in primary care in Latvia: A randomised controlled intervention study 4. Changes in antibiotic prescribing habits (diagnostic process, antibiotic prescribing and choice of antibiotics) after interventions - planned to published in August 2024 Likopa, Z., Kivite-Urtane, A. and Pavare. Changes in antibiotic prescribing habits (diagnostic process, antibiotic prescribing and choice of antibiotics) after introduction of point-of-care C-reactive protein testing and family physician education in primary care in Latvia: A randomised controlled intervention study |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Zane Likopa (zane.likopa@gmail.com). The data that support the findings of this study (anonymized dataset) are available on request from the corresponding author. According to the decision of the Research Ethics Committee of Riga Stradins University patient consent was not required because only the participating FP were exposed to the study interventions, but patients did not undergo any intervention and CRP testing was used only according to clinical indications as in routine practice. Patients were informed about the objective of the project, and they were told that specific anonymous clinical information related to the consultation was collected for the study purposes. All data is anonymous and there is no information that can be used to identify individual registry patients by personal analysis of the data. Participating FP is also considered to be confidential information. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 17/08/2021 | 16/05/2024 | Yes | No | |
| Interim results article | 21/09/2022 | 16/05/2024 | Yes | No |
Editorial Notes
20/05/2024: Study's existence confirmed by Riga Stradins University.
