Please use this identifier to cite or link to this item: https://hdl.handle.net/1959.11/19761
Title: Balancing Opposing Forces - A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention: The CORE Study
Contributor(s): Palmer, V J (author); Piper, Donella  (author)orcid ; Gunn, J (author); Iedema, R (author); Richard, L (author); Furler, J (author); Herrman, H (author); Cameron, J (author); Godbee, K (author); Pierce, D (author); Callander, R (author); Weavell, W (author)
Publication Date: 2016
Open Access: Yes
DOI: 10.1177/1609406916672216Open Access Link
Handle Link: https://hdl.handle.net/1959.11/19761
Abstract: Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs) has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE) was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users). Process evaluation data collection combines qualitative and quantitative methods with four aims: (1) to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2) to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3) to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4) to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.
Publication Type: Journal Article
Source of Publication: International Journal of Qualitative Methods, 15(1), p. 1-10
Publisher: University of Alberta
Place of Publication: Canada
ISSN: 1609-4069
Fields of Research (FoR) 2008: 150313 Quality Management
111709 Health Care Administration
150303 Corporate Governance and Stakeholder Engagement
Fields of Research (FoR) 2020: 420306 Health care administration
350701 Corporate governance
350715 Quality management
Socio-Economic Objective (SEO) 2008: 920208 Health Policy Evaluation
920204 Evaluation of Health Outcomes
Socio-Economic Objective (SEO) 2020: 200205 Health policy evaluation
200202 Evaluation of health outcomes
Peer Reviewed: Yes
HERDC Category Description: C1 Refereed Article in a Scholarly Journal
Appears in Collections:Journal Article

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