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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02286245
Recruitment Status : Completed
First Posted : November 7, 2014
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Isolated Fever Gastroenteritis Symptoms Other: focused Telephonic Medical Advice Other: Usual practice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cost effectiveness [ Time Frame: at 15 days ]
    Cost effectiveness based on the economic analysis in each arm (sick leaves, hospitalization, EMS or firemen use...)

  2. Care Mobile Units use [ Time Frame: at 15 days ]
  3. Emergency Medical Service use [ Time Frame: at 15 days ]
  4. Firemen use [ Time Frame: at 15 days ]
    Number of fireman use

  5. Recall at dispatching centre [ Time Frame: at 15 days ]
  6. Number and length of sick leave [ Time Frame: at 15 days ]
  7. All causes mortality [ Time Frame: at 15 days ]
  8. Morbidity [ Time Frame: at 15 days ]
  9. Patient satisfaction [ Time Frame: at 15 days ]
    Patient satisfaction evaluated by a 14 items questionnaire ans a numeric scale from 0 to 10

  10. Patient adhesion [ Time Frame: at 15 days ]
    Percentage of patient's adhesion to the advice and/or drug prescriptions

  11. Clinical outcome [ Time Frame: at 15 days ]
    Percentage of relieved patients

  12. Number of stay in intensive care unit [ Time Frame: at 15 days ]
  13. Number of hospitalisation [ Time Frame: at 15 days ]
  14. Number of patients seen repeatedly [ Time Frame: at 15 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286245


Locations
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France
SAMU 93 - EA 3409 - Faculté de Médecine de Bobigny - Université Paris 13
Bobigny, Ile de France, France, 93009
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Frédéric ADNET, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02286245    
Other Study ID Numbers: K120104
2013-AO1722-43 ( Other Identifier: IDRCB )
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Triage
Hotline
Primary Health Care
Emergency Medical Service Communication Systems
Additional relevant MeSH terms:
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Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases