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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02625129
Other study ID # 21080
Secondary ID
Status Completed
Phase N/A
First received November 25, 2015
Last updated January 17, 2018
Start date February 2016
Est. completion date April 2017

Study information

Verified date January 2018
Source University of Waterloo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The study will be conducted at the Travel Health Network, a full-service travel medicine clinic located in St. Albert, Alberta. Care will be provided by a pharmacist with a specialized practice in travel medicine, authorization to prescribe vaccines and prescription drugs, and authorization to administer vaccines by injection.

The study will be a prospective mixed-methods cohort study, describing patients receiving care from a pharmacist-managed travel medicine clinic and their travel health needs, and evaluating their adherence to recommended vaccines and oral therapies, satisfaction with the care provided, and their health status and management of health issues arising while travelling. Chart reviews will elicit descriptive quantitative data related to patients' travel medicine needs and adherence to recommended vaccinations and oral pharmacotherapy, followed by surveys containing open-ended qualitative questions to elicit overall patient satisfaction and the management of any health issues encountered during travel. Due to the nature of the study involving patients presenting to the clinic for a consultation, neither a control group nor blinding is possible.

A convenience sample of 100 subjects will be enrolled.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pharmacist-provided travel care
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

Locations

Country Name City State
Canada Travel Health Network St. Albert Alberta

Sponsors (3)

Lead Sponsor Collaborator
University of Waterloo Travel Health Network, University of Mississippi Medical Center

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 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
Secondary Frequency of reason(s) for declining any recommended vaccines or medications according to participant self-report through an online survey Response options: didn't feel I was at risk, cost, concern about vaccine ingredients or safety, other (specify) 1 week following return from travel according to participant's planned itinerary
Secondary Number of reports of any health issues over the course of travel according to participant self-report through an online survey Response options: Traveller's diarrhea, Altitude sickness, Malaria, Fever (Dengue, Chikungunya), Respiratory illness, Other (specify) 1 week following return from travel according to participant's planned itinerary
Secondary Frequency of management strategies of any health issues over the course of travel according to participant self-report through an online survey Response options: Nothing - it went away on its own, Took a non-prescription medication I had purchased before departure, Took a non-prescription medication I purchased while travelling, Called or emailed the Travel Health Network for advice, Searched the internet for guidance on how to manage it, Saw a physician while travelling, Saw a physician upon returning home, Other (specify) 1 week following return from travel according to participant's planned itinerary
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