Skip to main content
OpenTrials
Completed

NCT Number: NCT02286245

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

focused Telephonic Medical Advice

Other

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 practice

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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.

Acronym: CMTp

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2014
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.