Effective strategies for implementing a multicenter international clinical trial

Aitken, LM; Pelter, MM; Carlson, B; Marshall, AP; Cross, R; McKinley, S; Dracup, K

Effective strategies for implementing a multicenter international clinical trial

Aitken, LM Pelter, MM Carlson, B Marshall, AP

Cross, R McKinley, S Dracup, K

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Publication Type:: Journal Article
Citation:: Journal of Nursing Scholarship, 2008, 40 (2), pp. 101 - 108
Issue Date:: 2008-06-01

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Field	Value	Language
dc.contributor.author	Aitken, LM	en_US
dc.contributor.author	Pelter, MM	en_US
dc.contributor.author	Carlson, B	en_US
dc.contributor.author	Marshall, AP https://orcid.org/0000-0001-7692-403X	en_US
dc.contributor.author	Cross, R	en_US
dc.contributor.author	McKinley, S	en_US
dc.contributor.author	Dracup, K	en_US
dc.date.issued	2008-06-01	en_US
dc.identifier.citation	Journal of Nursing Scholarship, 2008, 40 (2), pp. 101 - 108	en_US
dc.identifier.issn	1527-6546	en_US
dc.identifier.uri	http://hdl.handle.net/10453/12824
dc.description.abstract	Purpose: International collaboration in research is essential in order to improve worldwide health. The purpose of this paper is to describe strategies used to administer an international multicenter trial to assess the effectiveness of a nursing educational intervention. Design: The study design was a two-group randomized multicenter international clinical trial conducted to determine whether a brief education and counselling intervention delivered by a nurse could reduce prehospital delay in the event of symptoms suggestive of acute coronary syndrome (ACS) in patients previously diagnosed with cardiovascular disease. Method: A flexible but well-defined project structure showed intervention consistency in five sites among three countries and included experienced project coordinators, multidimensional communication methods, strategies to optimize intervention fidelity, site-specific recruitment and retention techniques, centralized data management, and consideration of ethical and budgetary requirements. Findings: Staff at five sites enrolled 3,522 participants from three countries and achieved 80% follow-up obtained at both 12 and 24 months. Conclusion: Multidimensional approaches to maintain consistency across study sites, while allowing flexibility to meet local expectations and needs, contributed to the success of this trial. Clinical Relevance: In order to support appropriate development of an evidence base for practice, nursing interventions should be tested in multiple settings. A range of strategies is described in this paper that proved effective in conducting a multicenter international trial. © 2008 Sigma Theta Tau International.	en_US
dc.relation.ispartof	Journal of Nursing Scholarship	en_US
dc.relation.isbasedon	10.1111/j.1547-5069.2008.00213.x	en_US
dc.subject.classification	Nursing	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Myocardial Infarction	en_US
dc.subject.mesh	Communication	en_US
dc.subject.mesh	Clinical Nursing Research	en_US
dc.subject.mesh	Research Design	en_US
dc.subject.mesh	Patient Selection	en_US
dc.subject.mesh	International Cooperation	en_US
dc.subject.mesh	United States	en_US
dc.subject.mesh	Australia	en_US
dc.subject.mesh	New Zealand	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Male	en_US
dc.subject.mesh	Patient Education as Topic	en_US
dc.subject.mesh	Multicenter Studies as Topic	en_US
dc.subject.mesh	Randomized Controlled Trials as Topic	en_US
dc.title	Effective strategies for implementing a multicenter international clinical trial	en_US
dc.type	Journal Article
utslib.citation.volume	2	en_US
utslib.citation.volume	40	en_US
utslib.for	1110 Nursing	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
utslib.copyright.status	closed_access
pubs.issue	2	en_US
pubs.publication-status	Published	en_US
pubs.volume	40	en_US

Abstract:

Purpose: International collaboration in research is essential in order to improve worldwide health. The purpose of this paper is to describe strategies used to administer an international multicenter trial to assess the effectiveness of a nursing educational intervention. Design: The study design was a two-group randomized multicenter international clinical trial conducted to determine whether a brief education and counselling intervention delivered by a nurse could reduce prehospital delay in the event of symptoms suggestive of acute coronary syndrome (ACS) in patients previously diagnosed with cardiovascular disease. Method: A flexible but well-defined project structure showed intervention consistency in five sites among three countries and included experienced project coordinators, multidimensional communication methods, strategies to optimize intervention fidelity, site-specific recruitment and retention techniques, centralized data management, and consideration of ethical and budgetary requirements. Findings: Staff at five sites enrolled 3,522 participants from three countries and achieved 80% follow-up obtained at both 12 and 24 months. Conclusion: Multidimensional approaches to maintain consistency across study sites, while allowing flexibility to meet local expectations and needs, contributed to the success of this trial. Clinical Relevance: In order to support appropriate development of an evidence base for practice, nursing interventions should be tested in multiple settings. A range of strategies is described in this paper that proved effective in conducting a multicenter international trial. © 2008 Sigma Theta Tau International.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/12824