The Use of a Monitoring Device by General Practitioners During Out-of-hours Care

NCT05222711 | Unknown

• 1 other identifier: ACHG
• Study Type: interventional
• Target: 866
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emergencies; Heart Failure; Pulmonary Embolism; Acute Exacerbation of Chronic Obstructive Pulmonary Disease; Asthma; Acute Coronary Syndrome; Acute Myocardial Infarction; Atrial Fibrillation; Atrial Flutter; Hyperventilation; Pneumonia; Pneumothorax; Cardiac Arrest; Pulmonary Edema; Rhythm; Abnormal

Keywords

general practioner; monitoring device; vital parameters; ECG; out-of-hours care; RCT; Family practice

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• 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.

  30 days after intervention

Other Outcomes (4)

• 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

  until study completion, at 6 months

• 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?

  until study completion, at 6 months

• 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?

  until study completion, at 6 months

Study Arms (2)

Monitor used

ACTIVE COMPARATOR

The device is applied and the GP provides usual care.

Device: Use of the PICO(TM) monitoring device

Usual care

NO INTERVENTION

Usual care is provided by the GP.

Interventions

Use of the PICO(TM) monitoring device DEVICE

The aim is to record if the outcome (referral or not) is influenced by the results of the parameters and/or the ECG.

Monitor used

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 refusing to participate

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

CatholicULeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (14)

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  PMID: 31650057 BACKGROUND

Related Links

• Organisation of health care in Belgium - emergency services 2010-2018
• Tool for randomisation
• WMA Declaration of Helsinki concerning the inclusion of patients in medical studies
• The factory where the PICO(TM) monitoring device is build
• Core Team (2020). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria.
• International Classification of Primary Care (ICPC) version 6, March 2018
• Statistical tool MedCalc
• Article in Dutch on pulse oximetry screening in general practice: Renier W; Buntinx F. Pulsoximetriescreening in de huisartsenpraktijk. Heeft het invloed op het beleid? Huisarts Nu 2010;39:190-204.
• Article in Dutch on pulse oximetry: indications and observations in case of COPD - Schermer T, Leenders J, In 't Veen H, Van den Bosch W, Wissink A, Smeele I, Chavannes N. Pulsoximetrie: indicaties en observaties bij COPD. Huisarts Wet 2010;53(6):30
• Study in British Medical Journal (BMJ) Innovations: 15. Renier WS, Erard K, Sabbe M, Hubloue I, Verbakel JY, Aertgeerts B, Buntinx F. Analytical accuracy of the handheld PICO monitoring device during emergencies. BMJ Innovations 2019;5:20-27.
• Chapter 13 in the book of Rothman KJ, Greenland S, Lash TL. Modern Epidemiology. Chapter 13: Fundamentals of Epidemiologic Data Analysis (Greenland S and Rothman KJ) p213-237. Wolters Kluwer/Lippincott Williams \& Wilkin ®2008.

MeSH Terms

Conditions

Emergencies; Heart Failure; Pulmonary Embolism; Asthma; Acute Coronary Syndrome; Atrial Fibrillation; Atrial Flutter; Hyperventilation; Pneumonia; Pneumothorax; Heart Arrest; Pulmonary Edema; Arrhythmias, Cardiac

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Myocardial Ischemia; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiratory Tract Infections; Infections; Pleural Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jan Y Verbakel, MD, PhD

  ACHG

  STUDY CHAIR

Central Study Contacts

Walter S Renier, MD, PhD

CONTACT

+32477861777; walter.renier@gmail.com

Jan Y Verbakel, MD, PhD

CONTACT

+32498828605; jan.verbakel@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: pragmatic randomised controlled trial

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: February 3, 2022
• Study Start: May 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)