The Use of a Monitoring Device by General Practitioners During Out-of-hours Care (NCT05222711) | Clinical Trial Compass
UnknownNot Applicable
The Use of a Monitoring Device by General Practitioners During Out-of-hours Care
Belgium866 participantsStarted 2022-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.