Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT04470518
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tine.deburghgraeve@kuleuven.be', 'phone': '+3216377276', 'title': 'Tine De Burghgraeve, PhD', 'organization': 'Leuven Unit Health Technology Assessment Research, KU Leuven'}, 'certainAgreement': {'otherDetails': "Investigator may only publish the Results provided that Sponsor has duly published the main Study publication. Once the main Study publication has been duly published by the Sponsor, Investigator are entitled to publish the Results provided that Sponsor has granted its prior written approval with Principal Investigator's proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'description': 'Admission to hospital at the index consultation + Admission to hospital day 1-30', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).', 'otherNumAtRisk': 2988, 'deathsNumAtRisk': 2988, 'otherNumAffected': 32, 'seriousNumAtRisk': 2988, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").', 'otherNumAtRisk': 3762, 'deathsNumAtRisk': 3762, 'otherNumAffected': 64, 'seriousNumAtRisk': 3762, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hospitalisation', 'notes': 'hospitalisation due to infections, not caused by the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2988, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 3762, 'numEvents': 64, 'numAffected': 64}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '466', 'groupId': 'OG000'}, {'value': '817', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be registered immediately at the index consultation (immediately after the intervention)', 'description': 'The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Recovery During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This outcome will be checked from the diary (via app for parents) from first day after the intervention until day of full clinical recovery (up to maximum 30 days after after the intervention)', 'description': 'the duration (in days) until reaching full clinical recovery', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Additional Investigations at Index Consultation and/or During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000'}, {'value': '517', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This composite outcome will be registered immediately after the intervention and/or checked from the patient health record from the first day to day 30 after the intervention', 'description': 'the percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0) and/or during follow-up (day 1 to day 30)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Re-consultation During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '770', 'groupId': 'OG000'}, {'value': '968', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be checked from the patient health record from first day to day 30 after the intervention', 'description': 'percentage of subjects who re-consulted their physician during follow-up (day 1 to day 30)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Antibiotic Prescribing Rate During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '291', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be checked from the patient health record first day to day 30 after the intervention', 'description': 'percentage of subjects who were prescribed antibiotic treatment during follow-up (day 1 to day 30)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Additional Testing at Index Consultation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Additional Testing During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during follow-up from first day to day 30 after the intervention', 'description': 'percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) during follow-up (day 1 to day 30)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Referral to Hospital at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'percentage of subjects referred to hospital at index consultation (day 0)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Referral to Hospital During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during follow-up from first day to day 30 after the intervention', 'description': 'percentage of subjects referred to hospital during follow-up (day 1 to day 30)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Admission to Hospital at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'percentage of subjects admitted to hospital at index consultation (day 0)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Admission to Hospital During Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during follow-up from first day to day 30 after the intervention', 'description': 'percentage of subjects admitted to hospital during follow-up (day 1 to day 30)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mortality at Day 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'percentage of subjects who died at index consultation (day 0)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mortality During Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during follow-up from first day to day 30 after the intervention', 'description': 'percentage of subjects who died during follow-up (day 1 to day 30)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical Recovery at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '2539', 'groupId': 'OG000'}, {'value': '3200', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at day 7 after the intervention', 'description': 'percentage of subjects with full clinical recovery at day 7', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinical Recovery at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'OG000'}, {'value': '3762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'classes': [{'categories': [{'measurements': [{'value': '2967', 'groupId': 'OG000'}, {'value': '3747', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at day 30 after the intervention', 'description': 'percentage of subjects with full clinical recovery at day 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Patient's Experience Through Semi-structured Interviews", 'timeFrame': 'within 7 days after the intervention', 'description': "Patient's experience through semi-structured interviews with pre-defined topic guide", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Parent's Experience Through Semi-structured Interviews", 'timeFrame': 'within 7 days after the intervention', 'description': "Parent's experience through semi-structured interviews with pre-defined topic guide", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Physician's Experience Through Semi-structured Interviews", 'timeFrame': 'within 7 days after the intervention', 'description': "Physician's experience through semi-structured interviews with pre-defined topic guide", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost-effectiveness of the Intervention', 'timeFrame': 'will be assessed retrospectively after data collection has finished (24 months of recruitment)', 'description': 'Cost-effectiveness of the intervention: healthcare expenditures in terms of hospitalization, consultations, pharmaceuticals (reimbursed and non-reimbursed), productivity, quality of life', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Whose Physician Was Non-Adherent to the Diagnostic Algorithm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2986', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}], 'classes': [{'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'clinicians could deviate from the proposed diagnostic algorithm. This outcome measure comprise the percentage of participants whose physician was non-adherent to the diagnostic algorithm. This is not a protocol violation, since deviating from the algorithm was a possibility if the physician deems this necessary.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'missing data from 2 participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '82', 'numSubjects': '2988'}, {'groupId': 'FG001', 'numUnits': '89', 'numSubjects': '3762'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '82', 'numSubjects': '2988'}, {'groupId': 'FG001', 'numUnits': '89', 'numSubjects': '3762'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'general practices'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'BG000'}, {'value': '3762', 'groupId': 'BG001'}, {'value': '6750', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention: Diagnostic Algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice\n\ndiagnostic algorithm: Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'BG000'}, {'value': '3762', 'groupId': 'BG001'}, {'value': '6750', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'BG000', 'lowerLimit': '1.6', 'upperLimit': '7.1'}, {'value': '3.9', 'groupId': 'BG001', 'lowerLimit': '1.8', 'upperLimit': '7.2'}, {'value': '3.75', 'groupId': 'BG002', 'lowerLimit': '1.75', 'upperLimit': '7.08'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'boy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'BG000'}, {'value': '3762', 'groupId': 'BG001'}, {'value': '6750', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1566', 'groupId': 'BG000'}, {'value': '1881', 'groupId': 'BG001'}, {'value': '3447', 'groupId': 'BG002'}]}]}, {'title': 'girl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'BG000'}, {'value': '3762', 'groupId': 'BG001'}, {'value': '6750', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1421', 'groupId': 'BG000'}, {'value': '1881', 'groupId': 'BG001'}, {'value': '3302', 'groupId': 'BG002'}]}]}, {'title': 'prefer not to say', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'BG000'}, {'value': '3762', 'groupId': 'BG001'}, {'value': '6750', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2988', 'groupId': 'BG000'}, {'value': '3762', 'groupId': 'BG001'}, {'value': '6750', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2988', 'groupId': 'BG000'}, {'value': '3762', 'groupId': 'BG001'}, {'value': '6750', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-28', 'size': 8240011, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-28T14:24', 'hasProtocol': True}, {'date': '2024-03-28', 'size': 300439, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-28T13:52', 'hasProtocol': False}, {'date': '2020-10-16', 'size': 384369, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-28T13:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "Owing to study procedures, children, their parents and physicians will not be masked to the practices' random allocation."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicentre, cluster-randomized, parallel group pragmatic trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2020-07-02', 'resultsFirstSubmitDate': '2025-02-28', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-03', 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Additional Testing at Index Consultation', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0)'}, {'measure': 'Additional Testing During Follow-up', 'timeFrame': 'during follow-up from first day to day 30 after the intervention', 'description': 'percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) during follow-up (day 1 to day 30)'}, {'measure': 'Referral to Hospital at Day 0', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'percentage of subjects referred to hospital at index consultation (day 0)'}, {'measure': 'Referral to Hospital During Follow-up', 'timeFrame': 'during follow-up from first day to day 30 after the intervention', 'description': 'percentage of subjects referred to hospital during follow-up (day 1 to day 30)'}, {'measure': 'Admission to Hospital at Day 0', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'percentage of subjects admitted to hospital at index consultation (day 0)'}, {'measure': 'Admission to Hospital During Follow-up', 'timeFrame': 'during follow-up from first day to day 30 after the intervention', 'description': 'percentage of subjects admitted to hospital during follow-up (day 1 to day 30)'}, {'measure': 'Mortality at Day 0', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'percentage of subjects who died at index consultation (day 0)'}, {'measure': 'Mortality During Follow up', 'timeFrame': 'during follow-up from first day to day 30 after the intervention', 'description': 'percentage of subjects who died during follow-up (day 1 to day 30)'}, {'measure': 'Clinical Recovery at Day 7', 'timeFrame': 'at day 7 after the intervention', 'description': 'percentage of subjects with full clinical recovery at day 7'}, {'measure': 'Clinical Recovery at Day 30', 'timeFrame': 'at day 30 after the intervention', 'description': 'percentage of subjects with full clinical recovery at day 30'}, {'measure': "Patient's Experience Through Semi-structured Interviews", 'timeFrame': 'within 7 days after the intervention', 'description': "Patient's experience through semi-structured interviews with pre-defined topic guide"}, {'measure': "Parent's Experience Through Semi-structured Interviews", 'timeFrame': 'within 7 days after the intervention', 'description': "Parent's experience through semi-structured interviews with pre-defined topic guide"}, {'measure': "Physician's Experience Through Semi-structured Interviews", 'timeFrame': 'within 7 days after the intervention', 'description': "Physician's experience through semi-structured interviews with pre-defined topic guide"}, {'measure': 'Cost-effectiveness of the Intervention', 'timeFrame': 'will be assessed retrospectively after data collection has finished (24 months of recruitment)', 'description': 'Cost-effectiveness of the intervention: healthcare expenditures in terms of hospitalization, consultations, pharmaceuticals (reimbursed and non-reimbursed), productivity, quality of life'}, {'measure': 'Number of Participants Whose Physician Was Non-Adherent to the Diagnostic Algorithm', 'timeFrame': 'This outcome will be registered immediately at the index consultation', 'description': 'clinicians could deviate from the proposed diagnostic algorithm. This outcome measure comprise the percentage of participants whose physician was non-adherent to the diagnostic algorithm. This is not a protocol violation, since deviating from the algorithm was a possibility if the physician deems this necessary.'}], 'primaryOutcomes': [{'measure': 'Antibiotic Prescribing Rate at Index Consultation (Immediate or Delayed)', 'timeFrame': 'This outcome will be registered immediately at the index consultation (immediately after the intervention)', 'description': 'The primary outcome is the percentage of participants who were prescribed antibiotic treatment (both immediate and delayed) at the index consultation as recorded by the treating physician.'}], 'secondaryOutcomes': [{'measure': 'Clinical Recovery During Follow-up', 'timeFrame': 'This outcome will be checked from the diary (via app for parents) from first day after the intervention until day of full clinical recovery (up to maximum 30 days after after the intervention)', 'description': 'the duration (in days) until reaching full clinical recovery'}, {'measure': 'Additional Investigations at Index Consultation and/or During Follow-up', 'timeFrame': 'This composite outcome will be registered immediately after the intervention and/or checked from the patient health record from the first day to day 30 after the intervention', 'description': 'the percentage of subjects receiving additional testing (including, but not limited to (X-Ray, blood tests, urine tests) at index consultation (day 0) and/or during follow-up (day 1 to day 30)'}, {'measure': 'Re-consultation During Follow-up', 'timeFrame': 'This outcome will be checked from the patient health record from first day to day 30 after the intervention', 'description': 'percentage of subjects who re-consulted their physician during follow-up (day 1 to day 30)'}, {'measure': 'Antibiotic Prescribing Rate During Follow-up', 'timeFrame': 'This outcome will be checked from the patient health record first day to day 30 after the intervention', 'description': 'percentage of subjects who were prescribed antibiotic treatment during follow-up (day 1 to day 30)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotic prescription', 'infections', 'decision tree', 'point-of-care C-reactive protein test', 'safetynet advice'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '29269559', 'type': 'BACKGROUND', 'citation': 'Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Bullens DMA, Shinkins B, Van den Bruel A, Buntinx F. Point-of-care C reactive protein to identify serious infection in acutely ill children presenting to hospital: prospective cohort study. Arch Dis Child. 2018 May;103(5):420-426. doi: 10.1136/archdischild-2016-312384. Epub 2017 Dec 21.'}, {'pmid': '24025452', 'type': 'BACKGROUND', 'citation': 'Verbakel JY, Aertgeerts B, Lemiengre M, Sutter AD, Bullens DM, Buntinx F. Analytical accuracy and user-friendliness of the Afinion point-of-care CRP test. J Clin Pathol. 2014 Jan;67(1):83-6. doi: 10.1136/jclinpath-2013-201654. Epub 2013 Sep 11. No abstract available.'}, {'pmid': '27716201', 'type': 'BACKGROUND', 'citation': 'Verbakel JY, Lemiengre MB, De Burghgraeve T, De Sutter A, Aertgeerts B, Shinkins B, Perera R, Mant D, Van den Bruel A, Buntinx F. Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial. BMC Med. 2016 Oct 6;14(1):131. doi: 10.1186/s12916-016-0679-2.'}, {'pmid': '41016406', 'type': 'DERIVED', 'citation': "Verbakel JY, Burvenich R, D'hulster E, De Rop L, Van den Bruel A, Anthierens S, Coenen S, De Sutter A, Heytens S, Joly L, Digregorio M, Laenen A, Luyten J, De Burghgraeve T. A clinical decision tool including a decision tree, point-of-care testing of CRP, and safety-netting advice to guide antibiotic prescribing in acutely ill children in primary care in Belgium (ARON): a pragmatic, cluster-randomised, controlled trial. Lancet. 2025 Oct 11;406(10512):1599-1610. doi: 10.1016/S0140-6736(25)01239-5. Epub 2025 Sep 25."}, {'pmid': '34980633', 'type': 'DERIVED', 'citation': 'Verbakel JYJ, De Burghgraeve T, Van den Bruel A, Coenen S, Anthierens S, Joly L, Laenen A, Luyten J, De Sutter A. Antibiotic prescribing rate after optimal near-patient C-reactive protein testing in acutely ill children presenting to ambulatory care (ARON project): protocol for a cluster-randomized pragmatic trial. BMJ Open. 2022 Jan 3;12(1):e058912. doi: 10.1136/bmjopen-2021-058912.'}]}, 'descriptionModule': {'briefSummary': 'Impact of clinical guidance \\& point-of-care CRP test in children: the ARON project Trial Design: multicentre, cluster-randomized, parallel group pragmatic trial Trial Participants and setting: Children aged 6 months to 12 years of age with an acute illness episode presenting to in-hours general practice or out-of-hospital community paediatrics offices\n\nIntervention(s) Diagnostic algorithm:\n\n1. Clinical decision tree: clinician\'s gut feeling something is wrong, dyspnea, temperature ≥40ºC\n2. YES to any : point-of-care CRP ≥5mg/L: additional testing or refer to secondary care \\<5mg/L: safety netting\\*, only prescribe antibiotics if advised (guidelines)\n3. NO to all : are AB considered? YES : point-of-care CRP ≥5mg/L: safety netting\\*, only prescribe antibiotics if advised (guidelines) \\<5mg/L: safety netting\\*, do not prescribe antibiotics NO: safety netting\n\n \\*safety netting advice:\n * inform parents on what to expect and what to look out for\n * interactive parent information booklet based on previous research\n\n Control: Diagnosis and Treatment/Management as per usual care:\n\n \\- guidance on AB prescribing:\n\n o Belgische Commissie voor de Coördinatie van het Antibioticabeleid (BAPCOC) guide (updated November 2019)\n\n o RIZIV consensus meeting report "Antibiotics in children in ambulatory care"\n\n Primary Endpoint: Antibiotic prescribing rate at index consultation\n\n Secondary Endpoint(s)\n\n \\- time until full clinical recovery (during follow up (day 1 to day 30))\n\n \\- additional investigations (at index consultation and/or during follow up (day 1 to day 30))\n\n \\- re-consultation (during follow up (day 1 to day 30))\n\n \\- antibiotic prescribing rate (during follow up (day 1 to day 30))\n\n Exploratory endpoints at the index consultation:\n * additional investigations (X-Ray, blood tests, urine tests, etc.)\n\n During a follow-up period (day 1 to day 30):\n\n \\- referral to hospital\n\n \\- additional investigations (X-Ray, blood tests, urine tests, etc.)\n * patients with full clinical recovery at day 7 and day 30\n * admission to hospital\n * mortality\n * cost-effectiveness\n * patient satisfaction\n * qualitative study: endpoints\n\n Planned Sample Size: 7000 Timing of the intervention: Intervention at index consultation (at presentation to primary care) Follow-up duration: 30 days follow-up Duration of the trial (FPI-CSR): 43 months', 'detailedDescription': 'The investigators aim to strengthen the assessment of acutely ill children in primary care, by introducing a diagnostic algorithm that can decrease antibiotic prescribing.\n\nIn light of the prior evidence and its results so far, the ARON trial will test the impact of a diagnostic algorithm including a standardised clinical assessment, a POC CRP test, and safety netting advice.\n\nTherefore, the investigators propose to assess the clinical and cost-effectiveness of a diagnostic algorithm which includes a decision tree, POC CRP and safety netting advice in acutely ill children aged 6 months to 12 years of age presenting to ambulatory care, on AB prescribing, referral/admission to hospital, additional testing, mortality, and patient satisfaction.\n\nMore specifically, the investigators\' research question is whether this diagnostic algorithm is able to safely reduce antibiotic prescribing in acutely ill children presenting to ambulatory care.\n\nThe decision whether or not to conduct a POC CRP test will depend on the standardized clinical assessment, i.e. a validated clinical decision tree, and subsequently for low-risk children on the intention to prescribe AB.\n\nThe investigators will provide clear evidence-based guidance on how to interpret the CRP test result as outlined below.\n\nA process evaluation will examine how clinicians use CRP testing in their practice and how parents experience these consultations.\n\nThe investigators propose a study, where children (6 months to 12 years of age) will be randomised to (a) a diagnostic algorithm with CRP testing and specific guidance on when to prescribe AB or (b) usual care. CRP testing will be done using a finger prick test (result within 4 minutes). The CRP level will then be given to the clinician who will communicate the result to the child/parents.\n\nThe investigators aim to recruit 7000 children and will collect data registered by the participating physician, from the child\'s health record and children/parents directly. The investigators will describe how the intervention has worked in practice and how clinicians/parents have experienced these consultations.\n\nGuidance will be part of a diagnostic algorithm which includes clinically guided POC CRP testing and safety netting advice to inform parents on what to expect and what to look out for.\n\nIndividual interviews will be conducted with clinicians and parents taking part in the trial within 30 days after the first contact consultation, to explore the social processes influencing embedding of the intervention within practice, and behaviour change techniques.\n\nThese individual telephone interviews will be performed with a selection of parents to address whether their concerns were discussed appropriately and whether their expectations were met and how they experienced the consultation and/or POC CRP testing.\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).\n\nThe findings of this study could change the practice of ambulatory care physicians and might be of great interest to parents and childcare providers. The investigators will publish the findings of this research in academic journals, present at national conferences and discuss results with groups responsible for the national guidance on how to assess acutely ill children (Domus Medica, SSMG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for practices:\n\n* Being able to recruit acutely ill children (ideally consecutively)\n* Agree to the terms of the clinical study agreement.\n\nExclusion Criteria for practices:\n\n* Currently using a POC CRP device as part of their routine care\n* No practices will be excluded on other grounds than the above. Age, demographics, geographic region will not be used to exclude eligible practices. This will provide us with a real-life, representative subset of ambulatory care physicians.\n\nInclusion criteria for children\n\n* Children aged 6 months to 12 years, provided informed consent can be obtained\n* presenting with an acute illness episode that started maximum 10 days before the index consultation\n\nExclusion criteria for children\n\n* Children who were previously included in this trial\n* children with an underlying known chronic condition (e.g. asthma, immune deficiency)\n* clinically unstable warranting immediate care\n* immunosuppressant medication taken in the previous 30 days\n* trauma as the main presenting problem\n* antibiotics taken in the previous 7 days\n* Unwillingness or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04470518', 'acronym': 'ARON', 'briefTitle': 'Impact of Clinical Guidance & Point-of-care CRP in Children: the ARON Project', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Impact of a Diagnostic Algorithm on Antibiotic Prescribing Rate and Further Management of Acutely Ill Children Presenting to Ambulatory Care: Multicentre, Cluster-randomized, Parallel Group Pragmatic Trial', 'orgStudyIdInfo': {'id': 'S62005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention: Diagnostic algorithm', 'description': 'diagnostic algorithm including a standardised clinical assessment, a Point-of-care C-reactive protein test, and safety netting advice', 'interventionNames': ['Other: diagnostic algorithm']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'In the control arm, patients will receive \'usual care\' left at the discretion of the treating physician.\n\nApart from the general training session for all participating physicians they have attended prior to recruitment and randomization, physicians in the control arm will not receive additional tools.\n\nThey are expected (but not forced) to follow the Belgian guidelines (as described in "BAPCOC National guidelines and the RIZIV consensus meeting "Rational use of antibiotics in children").'}], 'interventions': [{'name': 'diagnostic algorithm', 'type': 'OTHER', 'description': 'Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient\'s health record and on the e-CRF, including the clinical decision tree (clinician\'s gut feeling, body temperature, dyspnea).\n\nThe safety-netting advice will be supported by a parent information booklet, based on previous research (the "When should I worry"-interactive booklet (a guide to Coughs, Colds, Earache \\& Sore Throats), the "Mijn kind heeft koorts" booklet (Eefje de Bont, www.thuisarts.nl), and the "Caring for children with coughs"-leaflet (information about how to look after a child who has a cough and when to see the doctor)).', 'armGroupLabels': ['Intervention: Diagnostic algorithm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'GPs associated with KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Jan Y Verbakel, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov/34980633/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Study protocol is published and accessible. SAP, CSR, ICF and analytical code will be available after publishing the results in a medical journal. Individual patient data from this trial will not be published in the public domain.', 'ipdSharing': 'YES', 'description': 'Individual patient data from this trial will not be published in the public domain. Deidentified participant data is available for further analyses. Requests for data, with justification, should be sent to Jan Verbakel (Jan . verbakel @ kuleuven.be, Tine De Burghgraeve (tine . deburghgraeve @ kuleuven.be. The trial protocol is available online for an indefinite period.', 'accessCriteria': 'Individual patient data from this trial will not be published in the public domain. Deidentified participant data is available for further analyses. Requests for data, with justification, should be sent to JYV, TDB, or RB. The trial protocol is available online for an indefinite period.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, {'name': 'University Ghent', 'class': 'OTHER'}, {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, {'name': 'University of Liege', 'class': 'OTHER'}, {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, {'name': 'Université Catholique de Louvain', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Jan Verbakel', 'investigatorAffiliation': 'KU Leuven'}}}}