Evaluating the Ottawa Malaria Decision Aid

NCT01976325 | Unknown

• 1 other identifier: 2010462-01H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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:
• 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.
• Better decision quality will result in a greater level of adherence to prescribed malaria chemoprophylaxis.

Conditions

Malaria

Keywords

decision aid; imported malaria; malaria prevention and control; malaria chemoprophylaxis; mefloquine; lariam; atovaquone-proguanil; malarone; doxycycline; vibramycin

Outcome Measures

Primary Outcomes (1)

• Travellers' Knowledge Score

  The traveller's knowledge score will be calculated based on participant's answers to questions from the Ottawa Malaria Knowledge Scale (2007) and the Realistic Expectations Scale (O'Connor 1996). For each multiple choice question, every possible response contains a predetermined scoring scheme. The traveller's knowledge score is calculated by adding points from each question answered. The sum of points forms the traveller's knowledge score.

  One year

Secondary Outcomes (3)

• Decisional Conflict Score

  One year

• Preparation for Decision-making Score

  One year

• Medication Adherence Score

  One year

Study Arms (2)

Standard Care

NO INTERVENTION

This arm will receive no intervention; only standard medical care.

Decision Aid + Standard Care

EXPERIMENTAL

This group will receive the intervention (the Ottawa Malaria Decision Aid), in addition to standard medical care.

Other: Ottawa Malaria Decision Aid

Interventions

Ottawa Malaria Decision Aid OTHER

The Ottawa Malaria Decision Aid is a tool that helps patients become involved in decision making about which malaria prophylaxis pill is right for them to take. The decision aid provides information about the options for malaria chemoprophylaxis, information about the financial costs and time required to adhere to the course of preventative medication, and clarifies personal values. The decision aid is designed to complement counseling from a health practitioner.

Decision Aid + Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (3)

National Capital Region Occupational Health Clinic

Ottawa, Ontario, K1A 0K9, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

International Association for Medical Assistance to Travellers

Toronto, Ontario, M6K 3E3, Canada

RECRUITING

Related Publications (18)

• 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. No abstract available.

  PMID: 19750611 BACKGROUND

• Steffen R, deBernardis C, Banos A. Travel epidemiology--a global perspective. Int J Antimicrob Agents. 2003 Feb;21(2):89-95. doi: 10.1016/s0924-8579(02)00293-5.

  PMID: 12615369 BACKGROUND

• Conner BA. Expert recommendations for antimalarial prophylaxis. J Travel Med. 2001 Dec;8(Suppl 3):S57-64. No abstract available.

  PMID: 12186677 BACKGROUND

• Lell B, Luckner D, Ndjave 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. doi: 10.1016/S0140-6736(97)09222-2.

  PMID: 9504515 BACKGROUND

• 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. doi: 10.1086/322694. Epub 2001 Sep 5.

  PMID: 11528574 BACKGROUND

• 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. doi: 10.1136/bmj.327.7423.1078.

  PMID: 14604928 BACKGROUND

• 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. doi: 10.4269/ajtmh.1999.60.521.

  PMID: 10348223 BACKGROUND

• 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. doi: 10.1086/514710.

  PMID: 9770146 BACKGROUND

• 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. doi: 10.1111/j.1708-8305.1995.tb00663.x.

  PMID: 9815395 BACKGROUND

• 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. doi: 10.1086/367542. Epub 2003 Feb 14.

  PMID: 12594633 BACKGROUND

• Suh KN, Kain KC, Keystone JS. Malaria. CMAJ. 2004 May 25;170(11):1693-702. doi: 10.1503/cmaj.1030418.

  PMID: 15159369 BACKGROUND

• 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. doi: 10.1111/j.1708-8305.2006.00005.x.

  PMID: 16412104 BACKGROUND

• Morgan M, Figueroa-Munoz 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. doi: 10.1080/13557850500242035.

  PMID: 16191732 BACKGROUND

• 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.

  PMID: 19588325 BACKGROUND

• 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. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.

  PMID: 16908462 BACKGROUND

• 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. doi: 10.1016/j.pec.2005.05.014. Epub 2005 Jul 15.

  PMID: 16024212 BACKGROUND

• 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.

  PMID: 23953767 BACKGROUND

• 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.

  BACKGROUND

Related Links

• The Ottawa Hospital
• The Ottawa Hospital Research Institute
• Patient Decision Aids at The Ottawa Hospital Research Institute
• Canadian Centre for Occupational Health and Safety
• International Association for Medical Assistance to Travellers

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Anne E McCarthy, MD, MSc

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Catherine Ivory, PhD

  University of Ottawa, Faculty of Medicine

  STUDY CHAIR

• Louise Balfour, PhD

  Ottawa Hospital Research Institute

  STUDY CHAIR

• Charde A Morgan, MScPH

  Ottawa Hospital Research Institute

  STUDY CHAIR

Central Study Contacts

Charde A Morgan, MScPH

CONTACT

613-737-8899; cmorgan@ohri.ca

Anne E McCarthy, MD, MSc

CONTACT

613-737-8899; amccarthy@toh.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 5, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

CA (3)