Asthma Clinical Trial
Official title:
The Use of a Monitoring Device by General Practitioners During Out-of-hours Care: Protocol of a Prospective Randomised Controlled Trial
NCT number | NCT05222711 |
Other study ID # | ACHG |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2022 |
Est. completion date | December 2022 |
All calls that end up on the out-of-hours general practitioners' service (OHGPS), which contain a demand for an urgent home visit, are passed on to the on-call general practitioner (GP). These calls are randomized into two arms: after the patient's informed consent, they are assigned either to one arm where the monitoring device, PICO, is applied together with the GP's general care or to the other arm where only the usual care is provided. All data such as suspected diagnosis, treatment or referral, influence of the parameters, ECG and/or alarms on the management and the user-friendliness are recorded. After 30 days, the diagnosis and evolution is requested from the patient's own GP or, if referred to a hospital, in the hospital in order to be able to compare the effect of the approach by the GP between both arms. The aim is to investigate if 1/ the use of the PICO monitoring device could improve GPs' decisions to refer to hospital or not in urgent cases; 2/ there is a difference between the diagnosis with and without the use of the monitoring device using the final diagnosis by the electronic health record of the own GP of the patient; 3/ the call to send a GP for an emergency contained sufficient information for the OHGPS phone operator to take an appropriate decision; 4/ the build-in alarms help the GP during his intervention; 5/ the PICO is easy to use during an emergency; 6/ the use of the device makes them feel more confident in transmitting the information to the Medical Emergency Team.
Status | Not yet recruiting |
Enrollment | 866 |
Est. completion date | December 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - From the calls at the 112-1733 dispatch sent to the OHGPS dispatch centre, those for whom the decision by the OHGPS dispatcher is to send a GP for an urgent home visit. - All GPs on duty and chauffeurs of the OHGPS in Belgium, present during the study period are recruited after signing an ICF. GPs' age, gender and years of practice will be recorded. - All patients 18 years and older, for whom a home visit is requested, seen by a participating GP and if the informed consent form is signed either by the patient or by the legal representative, either onsite or at a later time. Exclusion Criteria: - Patients younger than 18 years - Patients not seen during home visits, - Patients failed to provide informed consent - Patients with an acute trauma but not in a possible life-threatening situation (e.g. a broken bone) - Victims found lying on the street - Patients seen after the intervention of an ambulance, a Primary Intervention Team (PIT) or a Medical Emergency Team (MET) - Patients not meeting inclusion criteria - Patients refusing to participate |
Country | Name | City | State |
---|---|---|---|
Belgium | CatholicULeuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
KU Leuven |
Belgium,
Bagnasco A, Costa A, Catania G, Zanini M, Ghirotto L, Timmins F, Sasso L. Improving the quality of communication during handover in a Paediatric Emergency Department: a qualitative pilot study. J Prev Med Hyg. 2019 Sep 30;60(3):E219-E225. doi: 10.15167/2421-4248/jpmh2019.60.3.1042. eCollection 2019 Sep. — View Citation
Byrne AJ, Jones JG. Responses to simulated anaesthetic emergencies by anaesthetists with different durations of clinical experience. Br J Anaesth. 1997 May;78(5):553-6. — View Citation
Dalbak LG, Straand J, Melbye H. Should pulse oximetry be included in GPs' assessment of patients with obstructive lung disease? Scand J Prim Health Care. 2015;33(4):305-10. doi: 10.3109/02813432.2015.1117283. Epub 2015 Dec 11. — View Citation
Flynn D, Francis R, Robalino S, Lally J, Snooks H, Rodgers H, McClelland G, Ford GA, Price C. A review of enhanced paramedic roles during and after hospital handover of stroke, myocardial infarction and trauma patients. BMC Emerg Med. 2017 Feb 23;17(1):5. doi: 10.1186/s12873-017-0118-5. Review. — View Citation
Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013 Sep 18;13:117. doi: 10.1186/1471-2288-13-117. — View Citation
Hansen MB, Lippert FK, Rasmussen LS, Nielsen AM. Systematic downloading and analysis of data from automated external defibrillators used in out-of-hospital cardiac arrest. Resuscitation. 2014 Dec;85(12):1681-5. doi: 10.1016/j.resuscitation.2014.08.038. Epub 2014 Oct 2. — View Citation
Hochstadt A, Chorin E, Viskin S, Schwartz AL, Lubman N, Rosso R. Continuous heart rate monitoring for automatic detection of atrial fibrillation with novel bio-sensing technology. J Electrocardiol. 2019 Jan - Feb;52:23-27. doi: 10.1016/j.jelectrocard.2018.10.096. Epub 2018 Nov 1. — View Citation
Park MH, de Asmundis C, Chierchia GB, Sarkozy A, Benatar A, Brugada P. First experience of monitoring with cardiac event recorder electrocardiography Omron system in childhood population for sporadic, potentially arrhythmia-related symptoms. Europace. 2011 Sep;13(9):1335-9. doi: 10.1093/europace/eur159. Epub 2011 May 26. — View Citation
Renier W, Geelen M, Steverlynck L, Wauters J, Aertgeerts B, Verbakel J, Vanbrabant P, Gillet JB, Sabbe M, Buntinx F. Can the heartscan be used for diagnosis and monitoring of emergencies in general practice? Acta Cardiol. 2012 Oct;67(5):525-31. — View Citation
Schols AMR, Dinant GJ, Hopstaken R, Price CP, Kusters R, Cals JWL. International definition of a point-of-care test in family practice: a modified e-Delphi procedure. Fam Pract. 2018 Jul 23;35(4):475-480. doi: 10.1093/fampra/cmx134. — View Citation
Sieber A, L'Abbate A, Kuch B, Wagner M, Benassi A, Passera M, Bedini R. Advanced instrumentation for research in diving and hyperbaric medicine. Undersea Hyperb Med. 2010 Sep-Oct;37(5):259-69. Erratum in: Undersea Hyperb Med. 2011 Jan-Feb;38(1):83. — View Citation
Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009 Jun 29;338:b2393. doi: 10.1136/bmj.b2393. — View Citation
Van den Bruel A, Thompson M, Buntinx F, Mant D. Clinicians' gut feeling about serious infections in children: observational study. BMJ. 2012 Sep 25;345:e6144. doi: 10.1136/bmj.e6144. — View Citation
Zicari AM, Marzo G, Rugiano A, Celani C, Carbone MP, Tecco S, Duse M. Habitual snoring and atopic state: correlations with respiratory function and teeth occlusion. BMC Pediatr. 2012 Nov 7;12:175. doi: 10.1186/1471-2431-12-175. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Do the reasons for encounter in the message from the OGHPS telephone operator to the on-call GP correspond to the severity of the condition (urgent versus non-urgent) as determined by the on-call GP at the patient's location | The reason for encounter which is given to the on-call GP to go for a home visit should point into the direction of an urgent home visit. This message is the one that the 112-1733 dispatcher has passed on to the OHGPS phone operator. The on-call GP then determines on the basis of the patient's complaints whether these complaints indeed correspond to the reason for requesting a home visit. By comparing these reasons, it is possible to establish a better triage protocol both for the OHGPS phone operator and for the 112-1733 dispatcher. | until study completion, at 6 months | |
Other | Do the PICO(TM) alarms set for SpO2 assist the GP when the upper or lower limit is exceeded in whether or not to refer the patient to a hospital? | The alarms of the PICO(TM) are set for SpO2 at = 92%, the international cut-off below which one can expect a worse outcome and that a referral to the hospital is strongly recommended if the value is below 90%. The on-call GP records on the intervention form if the alarm helped him/her in the approach of the patient by increasing or decreasing the level of urgency. | until study completion, at 6 months | |
Other | Do the PICO(TM) alarms set for the heart rate assist the GP when the upper or lower limit is exceeded in whether or not to refer the patient to a hospital? | The alarms of the PICO(TM) are set at the same upper and lower limits according to the limits of the Early Warning Score (EWS). For the heart rate (normal limits = 51-100 beats per minute (bpm)) the upper and lower limits are resp. <40 bpm and > 130 bpm. Once these limits are exceeded, one can expect a worse outcome and a referral to the hospital is strongly recommended. The on-call GP indicates on the intervention form if the alarm helped him/her in the approach of the patient by increasing or decreasing the level of urgency. | until study completion, at 6 months | |
Other | Do the PICO(TM) alarms set for the respiration rate assist the GP when the upper or lower limit is exceeded in whether or not to refer the patient to a hospital? | The alarms of the PICO(TM) are set at the same upper and lower limits according to the limits of the Early Warning Score (EWS). For the respiration rate (normal limits are 9-14 bpm) the upper limit is =30 bpm, the lower limit is <9 bpm. Once these limits are exceeded, one can expect a worse outcome and a referral to the hospital is strongly recommended. The on-call GP indicates on the intervention form if the alarm helped him/her in the approach of the patient by increasing or decreasing the level of urgency. | until study completion, at 6 months | |
Primary | The number of correct referred participants in the intervention arm is a minimum of 11% higher than the correct referred participants in the usual care arm. | A correct referral is defined as follows: a patient referred to hospital staying more than 12 hours in the hospital; a patient referred only for a diagnostic test, e.g. an X-Ray, an ECG, a blood test, advice of a consultant, and no hospitalisation followed; a patient referred to his own GP was not hospitalised within 72 hours for the same reason. The aim of the study is to investigate the percentage of correct referrals in both arms and to determine if the percentage in the intervention arm is 11% or more higher than in the usual care arm. | 30 days after intervention | |
Secondary | The rate of correct diagnosis in the intervention arm is a minimum of 11% higher than the rate of correct diagnosis in the usual care arm. | In the intervention form the GP on duty records the diagnosis. These diagnoses will be compared with the records of the final diagnosis in the electronic health record of the own GP when the patient is sent home or, when the patient is referred to the hospital in the final diagnosis made by the emergency department physician at arrival and after 30 days. The difference between correct diagnoses in the intervention arm should be a minimum of 11 % higher than in the usual care arm. | 30 days after intervention |
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