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

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

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.

Study Overview

• Status: Completed
• Conditions: Isolated Fever; Gastroenteritis Symptoms
• Intervention / Treatment: Other: focused Telephonic Medical Advice; Other: Usual practice

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.

• Study Type: Interventional
• Enrollment (Actual): 2498
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Bobigny, Ile de France, France, 93009
      • SAMU 93 - EA 3409 - Faculté de Médecine de Bobigny - Université Paris 13

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1: focused 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. Patients are invited to recall in case of worsening or onset of new symptoms and to get an appointment with their general practitioner during working hours.	Other: focused 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
Active Comparator: 2: Usual 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.	Other: Usual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods	Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods	at 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost effectiveness	Cost effectiveness based on the economic analysis in each arm (sick leaves, hospitalization, EMS or firemen use...)	at 15 days
Care Mobile Units use		at 15 days
Emergency Medical Service use		at 15 days
Firemen use	Number of fireman use	at 15 days
Recall at dispatching centre		at 15 days
Number and length of sick leave		at 15 days
All causes mortality		at 15 days
Morbidity		at 15 days
Patient satisfaction	Patient satisfaction evaluated by a 14 items questionnaire ans a numeric scale from 0 to 10	at 15 days
Patient adhesion	Percentage of patient's adhesion to the advice and/or drug prescriptions	at 15 days
Clinical outcome	Percentage of relieved patients	at 15 days
Number of stay in intensive care unit		at 15 days
Number of hospitalisation		at 15 days
Number of patients seen repeatedly		at 15 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Frédéric Adnet, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Reuter PG, Durand-Zaleski I, Ducros O, Grignon O, Megy-Michoux I, Sourbes A, Desmettre T, Javaud N, Lapostolle F, Vicaut E, Adnet F. Efficacy of emergency medical center use of a protocol during telephone calls to give medical advice related to fever or gastroenteritis: a cluster randomized controlled trial. Emergencias. 2021 Aug;33(4):292-298. English, Spanish.
• Reuter PG, Desmettre T, Guinemer S, Ducros O, Begey S, Ricard-Hibon A, Billier L, Grignon O, Megy-Michoux I, Latouff JN, Sourbes A, Latier J, Durand-Zaleski I, Lapostolle F, Vicaut E, Adnet F. Effectiveness and cost-effectiveness of telephone consultations for fever or gastroenteritis using a formalised procedure in general practice: study protocol of a cluster randomised controlled trial. Trials. 2016 Sep 22;17(1):461. doi: 10.1186/s13063-016-1585-9.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: November 5, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Primary Health Care; Triage; Emergency Medical Service Communication Systems; Hotline
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: K120104; 2013-AO1722-43 (Other Identifier: IDRCB)