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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

Tracking Information
First Submitted Date  ICMJE September 9, 2014
First Posted Date  ICMJE November 7, 2014
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE March 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02286245 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2014)
  • Cost effectiveness [ Time Frame: at 15 days ]
    Cost effectiveness based on the economic analysis in each arm (sick leaves, hospitalization, EMS or firemen use...)
  • 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 ]
    Number of fireman use
  • 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 satisfaction evaluated by a 14 items questionnaire ans a numeric scale from 0 to 10
  • Patient adhesion [ Time Frame: at 15 days ]
    Percentage of patient's adhesion to the advice and/or drug prescriptions
  • Clinical outcome [ Time Frame: at 15 days ]
    Percentage of relieved patients
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Patients Calling for Primary Care
Official Title  ICMJE Effectiveness and Cost-effectiveness of Medical Advice Given by Telephone for Primary Care: the Formalised Telephone Medical Advice Study, a Cluster Randomised Control Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Isolated Fever
  • Gastroenteritis Symptoms
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: focused Telephonic Medical Advice
  • 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.
    Intervention: Other: Usual practice
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2017)
2498
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2014)
2880
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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...)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02286245
Other Study ID Numbers  ICMJE K120104
2013-AO1722-43 ( Other Identifier: IDRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frédéric ADNET, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP