Non-inferiority Trials of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine. (aCTIVE)

September 27, 2017 updated by: Assistance Publique - Hôpitaux de Paris

A Prospective, Single-blind, Randomized Trial, of Non-inferiority of the Quality of Nurse Consultation Versus a Medical Consultation in Travel Medicine

A non inferiority mono-centre randomised single blind prospective study comparing a medical consultation versus nursing consultation, into two groups parallel without crossover.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The permanent Survey of French data"monitoring of tourist demand" shows that 20% of the French population over 15 years performed each year at least one trip abroad. Travel most frequently are destined for European countries (6 times out of 10). The fact remains, however, that the french travelers (roughly 4.5 million) then fall between 120 countries of which a quarter part of the health high risk area.

Most of these risks can be minimized if appropriate precautions are observed before, during, and after the travel.

The development of tourism of people living in France is a real public health issue.

In these conditions, the need for travel medicine becomes more pressing. Medical discipline in full expansion, it is initially preventive before the trip. The other role of the travel medicine is the diagnosis and the treatment of the pathology after the end of the travel, which involves strictly medical skills.

This research investigation is so limited to travel preventive consultation before departure.

Regarding the prevention of the risks related to the trip, the World Health Organization (WHO) emits the 3 following recommendations:

"Travelers who intend to visit a developing country should consult a travel medicine center or a doctor, before their departure...". The main elements to look for by the healthcare professional who leads the consultation include:

  • an assessment of any potential or underlying health problems
  • a risk assessment linked to the trip according to destination, the route during the stay, the type of trip, the conditions and the duration of the stay
  • the risk reduction strategy (Council in hygiene, nutrition) including the vaccinations and recommended therapeutics .

The consultation before the departure, interested on the promotion of health and the prevention of risks associated with travel. The aim is to propose suitable preventive measures. It cannot be a stereotyped speech depending on destinations, it is essential to adapt it to the person's situation.

Healthcare professionals must communicate effectively, so as to promote the understanding and retention of the information provided. The health promotion is one of the main skills invested by nurses.

The different investigation invites us to reflect on the new forms of health professionals cooperation. The investigator believe that the travel medicine offers opportunities in this way.

The hypothesis is : a nursing consultation in the travel medicine, subject to adequate training and a perfectly defined framework, can't meet the same criteria of quality of care than a medical consultation,

The expected results are an equivalence of results in terms of efficiency of support consultation.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93000
        • Recruiting
        • Service des Maladies Infectieuses et Tropicales, centre de conseils aux voyageurs, de vaccinations, Hôpital Avicenne
        • Contact:
        • Contact:
          • BOUCHAUD Olivier, Pr
          • Phone Number: 01 48 95 54 21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Traveler (male and female) over 18 years old (coming for travel consultation in a international center of vaccination)

Exclusion Criteria:

  • Children and pregnant women,

  • Travellers (man and woman) with co-morbidity factors as:

    • Hospitalization in the month previous consultation
    • Travelers with at least an one disease including an immune deficiency or dys-immunity, such as auto-immune disease,
    • Any recent discovery comorbidity (since less than 6 months)
    • Any traveler coming for consultation and bearer of signs of an acute health problem.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nursing consultation
travel preventive consultation was performed by nurse
Other: Nursing consultation
travel preventive consultation was performed by nurse
No Intervention: Medical consultation
travel preventive consultation was performed by a doctor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of memorization by travelers of the mains parameters related to the individual prevention of the traveler's Malaria, diarrhea and sexually transmitted infections.
Time Frame: At day 1
Evaluated by a post-consultation memorization survey
At day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality score of the support consultation evaluating the memorization of Information by travelers.
Time Frame: At day 1
Evaluated by memorisation survey
At day 1
Level of satisfaction of travelers
Time Frame: At day 1
The level of satisfaction will be assessed by a visual scale.
At day 1
The relevance of the choice of vaccinations proposed in relation to recommendations
Time Frame: At day 1
will be evaluated by a retrospective review
At day 1
The relevance of the choice of prescribed anti-malarials in relation to recommendation
Time Frame: At day 1
will be evaluated by a retrospective review
At day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Delphine LECLERC, Nurse, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

September 4, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 27, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • K100104J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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