Isolated FeverCMTpNCT02286245
The Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Patients Calling for Primary Care
A study testing focused Telephonic Medical Advice and Usual practice in people with Isolated Fever and Gastroenteritis Symptoms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Isolated Fever, Gastroenteritis Symptoms
- What is being tested?
- focused Telephonic Medical Advice and Usual practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,498 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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...)
Trial locations and contacts
1 site in 1 country.
France1 site
SAMU 93 - EA 3409 - Faculté de Médecine de Bobigny - Université Paris 13
Bobigny, Île-de-France Region, 93009
About this study
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.
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.
Read the 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.
- Conditions
- Isolated Fever, Gastroenteritis Symptoms
- Being tested
- focused Telephonic Medical Advice, Usual practice
- Keywords
- Triage, Hotline, Primary Health Care, Emergency Medical Service Communication Systems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused Telephonic Medical AdviceOther
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
Usual practiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1: focused Telephonic Medical Advice | Experimental | 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. Receives: Other: focused Telephonic Medical Advice |
| 2: Usual practice | Active comparator | 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. Receives: Other: Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 15 days
Secondary outcomes (14)
Cost effectiveness
Cost effectiveness based on the economic analysis in each arm (sick leaves, hospitalization, EMS or firemen use...)
Measured: at 15 days
Care Mobile Units use
Measured: at 15 days
Emergency Medical Service use
Measured: at 15 days
Firemen use
Number of fireman use
Measured: at 15 days
Recall at dispatching centre
Measured: at 15 days
Number and length of sick leave
Measured: at 15 days
All causes mortality
Measured: at 15 days
Morbidity
Measured: at 15 days
Patient satisfaction
Patient satisfaction evaluated by a 14 items questionnaire ans a numeric scale from 0 to 10
Measured: at 15 days
Patient adhesion
Percentage of patient's adhesion to the advice and/or drug prescriptions
Measured: at 15 days
Clinical outcome
Percentage of relieved patients
Measured: at 15 days
Number of stay in intensive care unit
Measured: at 15 days
Number of hospitalisation
Measured: at 15 days
Number of patients seen repeatedly
Measured: at 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Isolated FeverStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ADNET, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286245
- Sponsor's protocol ID
- K120104
- Other IDs
- 2013-AO1722-43
- Acronym
- CMTp
- Status last verified
- Jan 2017
- First submitted
- 9 Sep 2014
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34251142Reuter 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.
PubMed 27659897
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02286245
- Acronym / sponsor ID
- CMTp / K120104
- Conditions
- Isolated Fever, Gastroenteritis Symptoms
- Keywords
- Triage, Hotline, Primary Health Care, Emergency Medical Service Communication Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,498 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: focused Telephonic Medical Advice | Experimental | Other: focused Telephonic Medical AdviceThe 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. |
| 2: Usual practice | Active comparator | Other: Usual practiceThe 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Disease:
- Onset of symptoms for less than 72 hours
- Age ≥ 18 years caller
- Patient age ≥ 1 year
- Affiliation to the French National Health Service
Key exclusion criteria (4 listed)
- 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...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focused Telephonic Medical AdviceThe 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 | Other | 1: focused Telephonic Medical Advice |
| Usual practiceThe 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 | 2: Usual practice |
Primary outcome
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
Proportion of patient with physical consultation by a general practitioner or in an emergency department, during out-of-hours periods
14 secondary outcomes
Cost effectiveness
Time frame: at 15 days
Care Mobile Units use
Time frame: at 15 days
Emergency Medical Service use
Time frame: at 15 days
Firemen use
Time frame: at 15 days
Recall at dispatching centre
Time frame: at 15 days
Number and length of sick leave
Time frame: at 15 days
All causes mortality
Time frame: at 15 days
Morbidity
Time frame: at 15 days
Patient satisfaction
Time frame: at 15 days
Patient adhesion
Time frame: at 15 days
Clinical outcome
Time frame: at 15 days
Number of stay in intensive care unit
Time frame: at 15 days
Number of hospitalisation
Time frame: at 15 days
Number of patients seen repeatedly
Time frame: at 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 34251142Reuter 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.
- Derived from this study: PubMed 27659897Reuter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric ADNET, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focused Telephonic Medical Advice and Usual practice in people with Isolated Fever and Gastroenteritis Symptoms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02286245, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.