NCT02625129

Brief Summary

This study will evaluate the clinical effectiveness of, and patient satisfaction with, pre-travel consultations provided by a pharmacist with specialty training in travel medicine and the authorization to prescribe medications and administer vaccinations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

November 25, 2015

Last Update Submit

January 17, 2018

Conditions

Travel Medicine

Outcome Measures

Primary Outcomes (2)

  • The proportion of recommended pre-travel vaccinations administered before departure according to chart review

    From date of pre-travel consultation until the date of travel departure according to participant's planned itinerary, assessed up to September 2016.

    Up to 7 months.

  • The proportion of recommended pre-travel oral pharmacotherapies dispensed before departure by a community pharmacy according to electronic health record

    From date of pre-travel consultation until the date of travel departure according to participant's planned itinerary, assessed up to September 2016.

    Up to 7 months.

Secondary Outcomes (4)

  • Average satisfaction (along 1-5 scale) with care provided elicited through an online survey post-travel

    1 week following return from travel according to participant's planned itinerary

  • Frequency of reason(s) for declining any recommended vaccines or medications according to participant self-report through an online survey

    1 week following return from travel according to participant's planned itinerary

  • Number of reports of any health issues over the course of travel according to participant self-report through an online survey

    1 week following return from travel according to participant's planned itinerary

  • Frequency of management strategies of any health issues over the course of travel according to participant self-report through an online survey

    1 week following return from travel according to participant's planned itinerary

Study Arms (1)

Pharmacist-provided travel care

Other: Pharmacist-provided travel care

Interventions

Pharmacist-provided travel careOTHER

Subjects will receive a pre-travel consultation from a pharmacist with specialty training in travel medicine, and with authorization to prescribe medications and vaccines and administer injections

Pharmacist-provided travel care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of individuals presenting for travel consultations at the Travel Health Network. No restrictions will be placed related to patient demographics, destinations, or travel itineraries; however, travellers with an expected return date after September 1, 2016 will be excluded, to ensure complete follow-up and data analysis within the proposed project time frame. A convenience sample of 100 patients will be consecutively enrolled .

You may qualify if:

  • Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada

You may not qualify if:

  • Travellers with an expected return date after September 1, 2016
  • Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Travel Health Network

St. Albert, Alberta, T8N5H9, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 9, 2015

Study Start

February 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

CA(1)