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A sneak peek into our study protocol

Mon. 02. Jul 2018 11:28

IMA’s study protocol is confidential, thus it cannot be shared, but for those of you interested in the project and our methods, this blog post gives a glimpse of the research methods we use in our work with IMA.

The study protocol’s purpose is fourfold. First of all, it defines the purpose and scope of the project, which is to study the effects of tailored implementation by carrying out a controlled implementation intervention in complex real-life implementations of iCBT.

Secondly, it creates consensus and agreement on the study amongst the IMA consortium by establishing the two research questions;

1. Does the ItFits-toolkit lead to a higher uptake and normalisation of iCBT in routine mental healthcare than IAU (Implementation-As-Usual)?

2. Does the ItFits-toolkit lead to faster increase of uptake and normalisation of iCBT in routine mental healthcare than IAU?

Thirdly, it provides the basis for scientific and ethical approvals, and finally, it sets out the next steps in preparing for the study.

The study protocol also defines the difference between the method that the ItFits-toolkit will provide for implementation, and Implementation-As-Usual. This is a vital distinction because it lays the foundation for why the work of IMA is necessary and what makes the ItFits-toolkit a relevant tool.

Christiaan Vis, Scientific Coordinator in ImpleMentAll, explains why the study protocol is a crucial part of ImpleMentAll, “the generic protocol serves as an evaluation framework specifying a set of minimal requirements for answering one question: does the ItFits-toolkit work? It specifies the rationales, the design, end-points, methods and instruments of the study, as well as the experiment itself, i.e. comparing tailored implementation as operationalised by the ItFits-toolkit with usual implementation. All twelve implementation sites apply and adhere to this generic evaluation framework so we are able to analyse the effectiveness of the ItFits-toolkit within and across various healthcare settings.” Thus, the development and testing of the toolkit is the main focal point in this protocol.

The stepped-wedge trial design has been chosen for the IMA trial. This is a type of randomised controlled trial, which is structured to reduce bias when testing various hypotheses. In the project, the point in time that each implementation site receives the ItFits-toolkit is randomised. By the end of the trial, all implementation sites have received the ItFits-toolkit, thus acting sequentially as control and intervention condition.

There are two types of study participants; implementers who are directly involved in the development, coordination, and execution of implementation; and service delivery staff who are the ‘receivers’ of the implementation activities and are subject to changes in their daily work to implement iCBT.

The study protocol ends with defining the next steps, which are related to the agreement that has now been made with the trial sites about how to carry out the trials as well as the rest of the project.

Establishing a trial protocol for a study as complex as IMA is no easy feat, and many important decisions have been made in the process. Although it is now fixed, we are always open to discussing our choice of methods for the sake of learning from others’ experience.  

So, if you have input for/questions about our trial – or have experience with conducting complex scientific studies that you want to share – please comment below!