Abstract

Introduction

Building capacity to improve sex/gender knowledge and strengthen patient engagement in clinical trials requires training and support. The overall goal of this 2-year project is to refine, translate and evaluate two web-based open-access patient and investigator decision aids aimed to improve patient engagement partnerships in clinical trials.

Methods and analysis

Two decision aids were designed in Phase 1 of this programme of research and this protocol describes a subsequent sequential phased approach to refine/translate (Phase 2A) and conduct alpha/usability (Phase 2B) and beta/field (Phase 3) testing. Decision aid development is guided by the International Patient Decision Aid Standards, User-Centred Design, Ottawa Decision-Support Framework and the Ottawa Model of Research Use. We have integrated patient-oriented research methods by engaging patient partners across all phases of our programme of research. Decision aids will first be refined and then translated to French (Phase 2A). Eight iterative cycles of semistructured interviews with 40 participants (20 patient partners and 20 investigators) will be conducted to determine usability (Phase 2B). A pragmatic pre/post pilot study design will then be implemented for field/beta testing using another purposive sample of 80 English-speaking and French-speaking participants (40 patients and 40 investigators). The samples are purposive to ensure an equal representation of English-speaking and French-speaking participants and an equal representation of men and women. Since sex and/or gender differences in utilisation and effectiveness of decision aids have not been previously reported, Phase 3 outcomes will be reported for the total sample and separately for men and women.

Ethics and dissemination

Ethics approval has been granted from the University of Toronto (41109, 28 September 2021). Informed consent will be obtained from participants. Dissemination will include co-authored publications, conference presentations, educational national public forums, fact sheets/newsletters, social media sharing and videos/webinars.

Details

Title
Patient engagement partnerships in clinical trials (PEP-CT): protocol for the systematic development and testing of patient partner and investigator decision aids
Author
Parry, Monica 1   VIAFID ORCID Logo  ; Ceroni, Tina 2 ; Wells, David 3 ; Richards, Dawn P 2 ; Toupin-April, Karine 4 ; Ansari, Hafsa 1 ; Bjørnnes, Ann Kristin 5   VIAFID ORCID Logo  ; Burnside, Heather 1 ; Cavallo, Sabrina 6 ; Day, Andrew 7 ; Ellis, Anne 8 ; Feldman, Debbie 6 ; Gilron, Ian 9   VIAFID ORCID Logo  ; Adhiyat Najam 3 ; Zulfiqar, Zoya 1 ; Marlin, Susan 2 

1  Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada 
2  Clinical Trials Ontario, Toronto, Ontario, Canada 
3  Diabetes Action Canada, Toronto, Ontario, Canada 
4  School of Rehabilitation Sciences, University of Ottawa, Ottawa, Ontario, Canada; Research Institute, Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada; Institut du Savoir Montfort, Ottawa, Ontario, Canada 
5  Department of Nursing and Health Promotion, Oslo Metropolitan University, Oslo, Norway 
6  School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montreal, Quebec, Canada 
7  Department of Community Health and Epidemiology and CERU, Queen’s Unversity, Kingston, Ontario, Canada 
8  Department of Medicine, Queen’s University, Kingston, Ontario, Canada 
9  Departments of Anesthesiology and Perioperative Medicine, Biomedical and Molecular Sciences and School of Policy Studies, Queen’s University, Kingston, Ontario, Canada 
First page
e060267
Section
Patient-centred medicine
Publication year
2022
Publication date
2022
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1136/bmjopen-2021-060267
ProQuest document ID
2631426287
Copyright
© 2022 Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.