- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02625129
Effectiveness of and Satisfaction With a Pharmacist-managed Travel Medicine Clinic
Determining the Clinical Effectiveness and Patient Satisfaction of a Pharmacist-managed Travel Medicine Clinic Under an Expanded Scope of Practice
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Alberta
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St. Albert, Alberta, Canada, T8N5H9
- Travel Health Network
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pharmacist-provided travel care
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The proportion of recommended pre-travel vaccinations administered before departure according to chart review
Time Frame: Up to 7 months.
|
From date of pre-travel consultation until the date of travel departure according to participant's planned itinerary, assessed up to September 2016.
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Up to 7 months.
|
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The proportion of recommended pre-travel oral pharmacotherapies dispensed before departure by a community pharmacy according to electronic health record
Time Frame: Up to 7 months.
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From date of pre-travel consultation until the date of travel departure according to participant's planned itinerary, assessed up to September 2016.
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Up to 7 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average satisfaction (along 1-5 scale) with care provided elicited through an online survey post-travel
Time Frame: 1 week following return from travel according to participant's planned itinerary
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1 week following return from travel according to participant's planned itinerary
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|
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Frequency of reason(s) for declining any recommended vaccines or medications according to participant self-report through an online survey
Time Frame: 1 week following return from travel according to participant's planned itinerary
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Response options: didn't feel I was at risk, cost, concern about vaccine ingredients or safety, other (specify)
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1 week following return from travel according to participant's planned itinerary
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Number of reports of any health issues over the course of travel according to participant self-report through an online survey
Time Frame: 1 week following return from travel according to participant's planned itinerary
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Response options: Traveller's diarrhea, Altitude sickness, Malaria, Fever (Dengue, Chikungunya), Respiratory illness, Other (specify)
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1 week following return from travel according to participant's planned itinerary
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Frequency of management strategies of any health issues over the course of travel according to participant self-report through an online survey
Time Frame: 1 week following return from travel according to participant's planned itinerary
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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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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21080
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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