NCT02286245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,498

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

September 9, 2014

Last Update Submit

January 10, 2017

Conditions

Keywords

TriageHotlinePrimary Health CareEmergency Medical Service Communication Systems

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Cost effectiveness

    at 15 days

  • Care Mobile Units use

    at 15 days

  • Emergency Medical Service use

    at 15 days

  • Firemen use

    at 15 days

  • Recall at dispatching centre

    at 15 days

  • +9 more secondary outcomes

Study Arms (2)

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.

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.

Other: Usual practice

Interventions

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

1: focused Telephonic Medical Advice

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.

2: Usual practice

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bobigny, Île-de-France Region, 93009, France

Location

Related Publications (2)

  • 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 Officials

  • Frédéric ADNET, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

November 7, 2014

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations