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The Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Patients Calling for Primary Care

Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Primary Care: the Formalised Telephone Medical Advice Study, a Cluster Randomised Control Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02286245
Acronym
CMTp
Enrollment
2498
Registered
2014-11-07
Start date
2015-03-31
Completion date
2016-09-30
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis Symptoms, Isolated Fever

Keywords

Triage, Hotline, Primary Health Care, Emergency Medical Service Communication Systems

Brief summary

Telephone medical advice in general practice is expanding. The Cochrane Database concludes in 2008 that there is not enough data about its use regarding out-of-hours general practitioners workload, emergency department visits, cost, safety and patient satisfaction. The aim of this study is to assess the effectiveness of telephone medical advice given by a general practitioner in a call centre for patient presenting isolated fever or gastroenteritis symptoms.

Detailed description

This is a prospective, open label, cluster randomized trial of 2 880 expected patients who calling a French emergency medical service Dial 15 for fever or gastroenteritis symptoms during out-of-hours periods. All calls will be taken by a general practitioner (GP). Out-of-hours period is defined as 8 PM to 8 AM on weekdays, 1 PM to 8PM on Saturdays in addition to Sundays and holidays.To be exhaustive, we will enrol patients during one year. In the experimental arm, the GP will implement a protocol of care to each patient call. The protocol includes medical advice, drug prescription by phone and supervisory board. Patients are invited to recall in case of worsening or onset of new symptoms and to get an appointment with their GP during working hours. In the non-interventional arm, the GP will decide the need of telephone advice with or without drug prescription, home visit by a doctor, emergency department services with or without EMS system. We will recall every patient at 15+/-4 days.

Interventions

OTHERfocused Telephonic Medical Advice

The physician will implement a protocol of care to each patient call for an isolated fever and/or symptoms of gastroenteritis: medical advice, drug prescription by phone and supervisory board

OTHERUsual practice

The physician will decide for the same disease (isolated fever and/or symptoms of gastroenteritis) the need of telephone advice with or without drug prescription, home visit by a doctor, emergency department services with or without EMS system.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Disease: * Fever: temperature ≥ 38 ° C * Symptoms of gastroenteritis include nausea and / or vomiting and / or diarrhea * Onset of symptoms for less than 72 hours * Age ≥ 18 years caller * Patient age ≥ 1 year * Affiliation to the French National Health Service

Exclusion criteria

* Pregnancy * Severity criteria (fever\> 41 ° C, disturbance of consciousness, rash, dyspnea, signs of dehydration, chest pain, neurological signs, gastrointestinal bleeding) * Seeking advice from institutional correspondents (fire brigade, police, airport…) * Communication difficulties (non-communicating patient, language barrier...)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periodsat 15 daysProportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods

Secondary

MeasureTime frameDescription
Care Mobile Units useat 15 days
Emergency Medical Service useat 15 days
Firemen useat 15 daysNumber of fireman use
Recall at dispatching centreat 15 days
Number and length of sick leaveat 15 days
All causes mortalityat 15 days
Cost effectivenessat 15 daysCost effectiveness based on the economic analysis in each arm (sick leaves, hospitalization, EMS or firemen use...)
Patient satisfactionat 15 daysPatient satisfaction evaluated by a 14 items questionnaire ans a numeric scale from 0 to 10
Patient adhesionat 15 daysPercentage of patient's adhesion to the advice and/or drug prescriptions
Clinical outcomeat 15 daysPercentage of relieved patients
Number of stay in intensive care unitat 15 days
Number of hospitalisationat 15 days
Number of patients seen repeatedlyat 15 days
Morbidityat 15 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026