Evaluating the Ottawa Malaria Decision Aid
Information source: Ottawa Hospital Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Ottawa Malaria Decision Aid (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Ottawa Hospital Research Institute Official(s) and/or principal investigator(s): Anne E McCarthy, MD, MSc, Principal Investigator, Affiliation: The Ottawa Hospital Research Institute Catherine Ivory, PhD, Study Chair, Affiliation: University of Ottawa, Faculty of Medicine Louise Balfour, PhD, Study Chair, Affiliation: Ottawa Hospital Research Institute Charde A Morgan, MScPH, Study Chair, Affiliation: Ottawa Hospital Research Institute
Overall contact: Charde A Morgan, MScPH, Phone: 613-737-8899, Ext: 72424, Email: cmorgan@ohri.ca
Summary
BRIEF SUMMARY
Canadians often visit areas with malaria where the preventative drug chloroquine no longer
works.
This leaves Canadians with the choice to use three different drugs to prevent malaria -
atovaquone-proguanil, doxycycline, or mefloquine. There are more than 400 cases of malaria
reported in Canada each year, a few which result in death. These cases mainly occur in
people who do not take malaria pills as directed.
Investigators have developed the Ottawa Malaria Decision Aid (OMDA), which is a bilingual
(English and French) resource used to support malaria prevention decision-making. The OMDA
contains plain language, fact-based information and helps individuals to reflect on their
own values and beliefs so that they can make the best decision for their situation.
In this randomized control study, the investigators will attempt to find out if using the
OMDA before visiting a travel clinic affects decisional conflict and the way pills are
taken. Consenting travellers will be assigned to standard care or standard care plus the
malaria decision aid. Both groups will complete three questionnaires before and after travel
to look at the impact on decisional conflict, preparation for decision-making, decisional
regret and pill taking behaviour.
Travelers' malaria can be prevented. It is our hope that by using different methods of
presenting information, specifically by utilizing the OMDA, there will be an increase in
adherence to appropriate malaria prophylaxis which will ultimately result in a decrease in
malaria cases that arrive in Canada. This will translate into a decreased use of health care
dollars and unnecessary deaths.
The Objectives of this study are to evaluate whether the malaria decision aid can be
integrated into the pre-travel consultation process and can:
- improve a traveller's knowledge of malaria and prevention strategies;
- improve a traveller's preparation for decision-making;
- decrease decisional conflict; and
- affect levels of adherence to prescribed malaria chemoprophylaxis.
The hypotheses of this study are that:
1. A decision aid will improve the quality of decision-making about malaria
chemoprophylaxis by decreasing decisional conflict and increasing knowledge about
malaria and malaria pills.
2. Better decision quality will result in a greater level of adherence to prescribed
malaria chemoprophylaxis.
Clinical Details
Official title: Incorporation of the 'Ottawa Malaria Decision Aid' Into the Pre-travel Consultation Process: Assessment of Travelers' Knowledge, Decisional Conflict, Preparation for Decision-making and Medication Adherence Compared to Standard Care
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Travellers' Knowledge Score
Secondary outcome: Decisional Conflict ScorePreparation for Decision-making Score Medication Adherence Score
Detailed description:
RECRUITMENT
The participants will be recruited from the travel medicine clinic at The Ottawa Hospital
General Campus, the National Capital Region Occupational Health Clinic, and through The
International Association for Medical Assistance to Travellers (IAMAT), a non-profit
organization dedicated to travel health. The study will undergo a recruitment process that
is estimated to last for approximately one year, or until at least 100 patients complete all
three questionnaires.
Recruitment begins at the time of initial contact with the travel clinic or IAMAT. Travelers
routinely phone, email or fax the travel clinic to book their pre-travel consultation and
the clerk at the clinic records pertinent information.
Recruitment at The Ottawa Hospital - General Campus Recruitment begins at the time of
initial contact with the travel clinic. Travellers routinely phone the travel clinic to book
their pre-travel consultation and the clerk at the clinic records pertinent information. At
the time of booking, the clerk fills out a "Traveller Information Form", which contains an
individual's name and contact information, lists the dates they will travel, and the
countries that they plan to travel to. All travelers will be asked by the clerk if they
would agree to be contacted by a researcher for a study. If they say yes, and the countries
listed on the form are in line with those chosen for recruiting participants, the research
assistant will contact them by the email or telephone number listed. The research assistant
will send/read an email/telephone script which introduces the study and will ask
participants if they would be interested in learning more. If they say yes, they will be
provided with the study website information (a small paragraph describing the study with a
link to study registration). Because the investigators recognize the difficulty of writing
down website addresses, the traveller will have the option to provide the research assistant
with their email address, if the research assistant does not have it already, and have the
study website address sent to them electronically by the research assistant. The research
assistant will not retain any personal information for any clients contacted at any time in
the recruitment stage. The only information collected during recruitment will be the net
number of clients called/emailed, and the net number who indicated that they would be
interested in participating.
Recruitment at the National Capital Region Clinic Recruitment begins at the time of initial
contact with the travel clinic. Travellers routinely email the travel clinic. Then they are
sent a form to complete and email or fax. For all travellers planning to visit an area with
chloroquine-resistant malaria for one year or less, the clerk will send an email attachment
of the study recruitment information, including the study website information. No personal
information about the individuals contacted will be collected by the study team. The clerk
only will relay the net number of individuals contacted to the study research assistant.
Recruitment through travel health advertising: eNewsletters and social media Recruitment
will begin through social media and email newsletters to subscribing members. Travel
medicine associations with members who subscribe to receive travel health information will
post the recruitment script in eNewsletters and on social media websites as part of their
normal advertising procedures. When travellers observe the recruitment script in the
newsletter or on a social media website, they can click on the link located within it, which
will bring them to the study website. If they pass the eligibility criteria, individuals are
invited to proceed to complete the recruitment process as described below.
An example of one organization which will post the recruitment message is The International
Association for Medical Assistance to Travellers (IAMAT), a non-profit organization
dedicated to travel health. IAMAT specializes in providing pre-trip travel health advice
and coordinates an international network of physicians and travel clinics. IAMAT would add
the currently approved recruitment text to their eNewsletter, and put the text on their
social media websites. Only subscribing members to their email listserv or visitors to
their social media accounts will receive the information about the study.
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STUDY PROGRESSION
All potential study participants will be sent a link by email to the study website. In the
case of IAMAT, subscribing members will receive information about the study containing the
study link. Upon clicking on the link, they will be directed to the traveler information
and consent form page. The page contains information about why the research is being
conducted, the purpose of the study, a description of the study, outlines the risks and
benefits of participation, and asks participants for voluntary consent to participate.
If interested in participating, then they will be asked to acknowledge that they have
reviewed the traveler information and consent form page. Those agreeing to participate will
be directed to an eligibility page. They will be asked questions to ensure that they are
eligible for study participation. If they are eligible, they will be invited to
participate and register their email address for the study. They will be informed that by
logging on to the website, they will be providing their implied consent for participation in
the study.
Once a participant enters their registration information, they will be sent a link to their
email address that they must click on in order to begin the first survey.
All groups will complete all three surveys at the times described below. The randomization
process will take place during the Baseline survey.
- The Baseline survey is to be done before the pre-travel clinic consultation;
- The Post-Consult survey is to be completed immediately after the travel medicine
consultation; and
- The Post-chemoprophylaxis questionnaire is to be completed one week after the expected
date of finishing chemoprophylaxis.
Once a participant completes all three surveys, in return for their time and dedication to
the study, participants who reside in Canada will be offered a $5 gift card to a popular
Canadian coffee chain (Tim Horton's).
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RANDOMIZATION PROCESS
Upon beginning the Baseline questionnaire, all participants will be randomized centrally
into two groups.
- Group 1 will receive standard pre-travel information through the pre-travel
consultation process.
- Group 2 will receive The Ottawa Malaria Decision Aid plus standard pre-travel
information through the pre-travel consultation process.
For those randomized to Group 2, the decision aid has been embedded in the baseline survey.
The Decision Aid provides comparative information about malaria pill options; communicates
probabilities for the risk of malaria; and clarifies values.
All other questionnaires and standard medical care will remain the same for both groups of
participants.
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CONFIDENTIALITY
All data collected will be coded with an independent study number and kept anonymous. The
file linking codes to patient names will be stored in a locked filling cabinet at The Ottawa
Hospital and stored separately from the main project files in one of Dr. McCarthy's offices.
Only the research team will have access to these files.
Electronic files will contain anonymized information and will be password protected and
stored in the secure TOH servers behind the The Ottawa Hospital firewall. These data will
only contain assigned study numbers to identify data sets. Only the research team will have
access to this information.
Study records may be audited by the Ottawa Hospital Research Ethics Board (OHREB).
Participants will not be able to be identified in any of the publications resulting from
this project.
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PATIENT RISK
There are no risks anticipated in this study. Participation in the study is voluntary and
will not affect the participant's routine medical care. Patients expressing concerns about
the information in the decision aid will be referred to their individual physician or travel
clinic physician or nurse.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- An Adult 18 years of age or older
- Individuals who have contacted the travel clinic at The Ottawa Hospital, General
Campus, the National Capital Region Occupational Health Clinic or received study
information from IAMAT before they travel
- Travelling for less than one year
- Departing for the trip in more than one week
- Travelling to an area with known chloroquine-resistant malaria
Exclusion Criteria:
- The travellers not visiting areas with chloroquine resistant malaria
- Those travelling longer than one year
- Departing for the trip in less than one week
- Individuals younger than 18 years of age
- Those who are pregnant or intend to become pregnant during their travel
- Those who have severe kidney disease, severe liver disease, heart rhythm problems, or
a history of seizures
- Those who have a history of mental problems
- Those who have an allergy to Atovaquone-proguanil, Doxycycline or Mefloquine
- Those who are unable to understand written or spoken English or French due to
deafness, blindness, cognitive impairment or language barrier
Locations and Contacts
Charde A Morgan, MScPH, Phone: 613-737-8899, Ext: 72424, Email: cmorgan@ohri.ca
National Capital Region Occupational Health Clinic, Ottawa, Ontario K1A 0K9, Canada; Recruiting Louise J Levesque, RN, BScN, Phone: 613-946-5533, Email: louise.j.levesque@hc-sc.gc.ca Lisa Taras, MD, CCFP, Phone: 613-946-6583, Email: lisa.taras@hc-sc.gc.ca
Ottawa Hospital Research Institute, Ottawa, Ontario K1Y 4E9, Canada; Recruiting Charde A Morgan, MScPH, Phone: 613-737-8899, Ext: 72424, Email: cmorgan@ohri.ca Anne E McCarthy, MD, Phone: 613-737-8899, Ext: 78184, Email: amccarthy@toh.on.ca Anne E McCarthy, MD, MSc, Principal Investigator Charde A Morgan, MScPH, Sub-Investigator
International Association for Medical Assistance to Travellers, Toronto, Ontario M6K 3E3, Canada; Recruiting Tullia Marcolongo, Phone: 416-652-0137, Email: tullia@iamat.org
Additional Information
The Ottawa Hospital The Ottawa Hospital Research Institute Patient Decision Aids at The Ottawa Hospital Research Institute Canadian Centre for Occupational Health and Safety World Health Organization - Malaria Action Global Health Network Committee to Advise on Tropical Medicine and Travel (CATMAT) Travel Health at the Public Health Agency of Canada University of Ottawa Faculty of Medicine International Association for Medical Assistance to Travellers
Related publications: Committee to Advise on Tropical Medicine and Travel (CATMAT). Canadian recommendations for the prevention and treatment of malaria among international travellers--2009. Can Commun Dis Rep. 2009 Jul;35 Suppl 1:1-82. Steffen R, deBernardis C, Baños A. Travel epidemiology--a global perspective. Int J Antimicrob Agents. 2003 Feb;21(2):89-95. Conner BA. Expert recommendations for antimalarial prophylaxis. J Travel Med. 2001 Dec;8(Suppl 3):S57-64. Review. Lell B, Luckner D, Ndjavé M, Scott T, Kremsner PG. Randomised placebo-controlled study of atovaquone plus proguanil for malaria prophylaxis in children. Lancet. 1998 Mar 7;351(9104):709-13. Overbosch D, Schilthuis H, Bienzle U, Behrens RH, Kain KC, Clarke PD, Toovey S, Knobloch J, Nothdurft HD, Shaw D, Roskell NS, Chulay JD; Malarone International Study Team. Atovaquone-proguanil versus mefloquine for malaria prophylaxis in nonimmune travelers: results from a randomized, double-blind study. Clin Infect Dis. 2001 Oct 1;33(7):1015-21. Epub 2001 Sep 5. Schlagenhauf P, Tschopp A, Johnson R, Nothdurft HD, Beck B, Schwartz E, Herold M, Krebs B, Veit O, Allwinn R, Steffen R. Tolerability of malaria chemoprophylaxis in non-immune travellers to sub-Saharan Africa: multicentre, randomised, double blind, four arm study. BMJ. 2003 Nov 8;327(7423):1078. Sukwa TY, Mulenga M, Chisdaka N, Roskell NS, Scott TR. A randomized, double-blind, placebo-controlled field trial to determine the efficacy and safety of Malarone (atovaquone/proguanil) for the prophylaxis of malaria in Zambia. Am J Trop Med Hyg. 1999 Apr;60(4):521-5. Shanks GD, Gordon DM, Klotz FW, Aleman GM, Oloo AJ, Sadie D, Scott TR. Efficacy and safety of atovaquone/proguanil as suppressive prophylaxis for Plasmodium falciparum malaria. Clin Infect Dis. 1998 Sep;27(3):494-9. Sossouhounto RT, Soro BN, Coulibaly A, Mittelholzer ML, Stuerchler D, Haller L. Mefloquine in the Prophylaxis of P. Falciparum Malaria. J Travel Med. 1995 Dec 1;2(4):221-224. Hale BR, Owusu-Agyei S, Fryauff DJ, Koram KA, Adjuik M, Oduro AR, Prescott WR, Baird JK, Nkrumah F, Ritchie TL, Franke ED, Binka FN, Horton J, Hoffman SL. A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum. Clin Infect Dis. 2003 Mar 1;36(5):541-9. Epub 2003 Feb 14. Suh KN, Kain KC, Keystone JS. Malaria. CMAJ. 2004 May 25;170(11):1693-702. Review. Landry P, Iorillo D, Darioli R, Burnier M, Genton B. Do travelers really take their mefloquine malaria chemoprophylaxis? Estimation of adherence by an electronic pillbox. J Travel Med. 2006 Jan-Feb;13(1):8-14. Morgan M, Figueroa-Muñoz JI. Barriers to uptake and adherence with malaria prophylaxis by the African community in London, England: focus group study. Ethn Health. 2005 Nov;10(4):355-72. O'Connor AM, Bennett CL, Stacey D, Barry M, Col NF, Eden KB, Entwistle VA, Fiset V, Holmes-Rovner M, Khangura S, Llewellyn-Thomas H, Rovner D. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD001431. doi: 10.1002/14651858.CD001431.pub2. Review. Update in: Cochrane Database Syst Rev. 2011;(10):CD001431. Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. Epub 2006 Aug 14. Laupacis A, O'Connor AM, Drake ER, Rubens FD, Robblee JA, Grant FC, Wells PS. A decision aid for autologous pre-donation in cardiac surgery--a randomized trial. Patient Educ Couns. 2006 Jun;61(3):458-66. Epub 2005 Jul 15. White NJ, Pukrittayakamee S, Hien TT, Faiz MA, Mokuolu OA, Dondorp AM. Malaria. Lancet. 2014 Feb 22;383(9918):723-35. doi: 10.1016/S0140-6736(13)60024-0. Epub 2013 Aug 15. Review. Chiodini PL, Field VK, Hill DR, Whitty CJM and Lalloo DG. Guidelines for malaria prevention in travellers from the United Kingdom. London, Public Health England, July 2013.
Starting date: January 2014
Last updated: April 15, 2015
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