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

Primary Purpose

Isolated Fever, Gastroenteritis Symptoms

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
focused Telephonic Medical Advice
Usual practice
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Isolated Fever focused on measuring Triage, Hotline, Primary Health Care, Emergency Medical Service Communication Systems

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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...)

Sites / Locations

  • SAMU 93 - EA 3409 - Faculté de Médecine de Bobigny - Université Paris 13

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: focused Telephonic Medical Advice

2: Usual practice

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2014
Last Updated
January 10, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02286245
Brief Title
The Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Patients Calling for Primary Care
Acronym
CMTp
Official Title
Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Primary Care: the Formalised Telephone Medical Advice Study, a Cluster Randomised Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Isolated Fever, Gastroenteritis Symptoms
Keywords
Triage, Hotline, Primary Health Care, Emergency Medical Service Communication Systems

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2498 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: focused Telephonic Medical Advice
Arm Type
Experimental
Arm Description
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.
Arm Title
2: Usual practice
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
focused Telephonic Medical Advice
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual practice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods
Description
Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods
Time Frame
at 15 days
Secondary Outcome Measure Information:
Title
Cost effectiveness
Description
Cost effectiveness based on the economic analysis in each arm (sick leaves, hospitalization, EMS or firemen use...)
Time Frame
at 15 days
Title
Care Mobile Units use
Time Frame
at 15 days
Title
Emergency Medical Service use
Time Frame
at 15 days
Title
Firemen use
Description
Number of fireman use
Time Frame
at 15 days
Title
Recall at dispatching centre
Time Frame
at 15 days
Title
Number and length of sick leave
Time Frame
at 15 days
Title
All causes mortality
Time Frame
at 15 days
Title
Morbidity
Time Frame
at 15 days
Title
Patient satisfaction
Description
Patient satisfaction evaluated by a 14 items questionnaire ans a numeric scale from 0 to 10
Time Frame
at 15 days
Title
Patient adhesion
Description
Percentage of patient's adhesion to the advice and/or drug prescriptions
Time Frame
at 15 days
Title
Clinical outcome
Description
Percentage of relieved patients
Time Frame
at 15 days
Title
Number of stay in intensive care unit
Time Frame
at 15 days
Title
Number of hospitalisation
Time Frame
at 15 days
Title
Number of patients seen repeatedly
Time Frame
at 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ADNET, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAMU 93 - EA 3409 - Faculté de Médecine de Bobigny - Université Paris 13
City
Bobigny
State/Province
Ile de France
ZIP/Postal Code
93009
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34251142
Citation
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.
Results Reference
derived
PubMed Identifier
27659897
Citation
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.
Results Reference
derived

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

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