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Implementing a pilot study

You may have a really good innovation idea, which should produce great improvements in the patient pathway. Discussion with stakeholders may also have led to high levels of support for this innovation. However, your innovation still requires testing and piloting. In this step we will discuss how you can implement and test your innovative solution to a problem.

Pilot studies are an important component of the innovation process. They play a key role in the development and refinement of new service interventions and adoption of new technologies. Pilot studies are used to evaluate activities such as the feasibility of recruitment, assessment procedures, new methodologies and introduction of new service improvements. The component(s) of the pilot found to be unsatisfactory can be modified or removed from the subsequent main project. In addition, a pilot study provides the opportunity to develop more consistent practices to increase data integrity and decrease risk for patients. These good clinical practices include such things as: better data collection systems, better informed consent practices, robust monitoring and oversight procedures and regulatory reporting processes.

Pilot studies are exploratory and proof of principle projects, they do not hypothesis test. Typically data generated by a pilot is not combined with the data collected from the subsequent much larger main project. This is because it is likely the methods employed in the main study have been adapted or even radically changed since the pilot. Such changes in the methods risk adding additional probably unknown sources of variation that could compromise the findings of the main study.

To implement a pilot study you should consider a model of improvement and a tried and testing method of do so is the Plan, Do, Study, Act or PDSA Cycle. This is an easy to use tool to help implement and evaluate pilot studies. We will look at the PDSA Cycle in more detail in Week 4, but for present when designing and implementing a pilot study, consider some fundamental questions for example:

  • What are you trying to achieve?

   - It is important that you, and your team, know what you are trying to achieve. This informs the aims and objectives for your pilot study.

  • How will you know your innovation is an improvement as not all change is necessarily for the better?

   - What will you measure and how? Think back to how you measured your current service. What is your criterion for success? For examples a 20% reduction is turnaround time for thyroid function tests requests from primary care.

  • What changes can we make that will result in an improvement? See Step 1.11.

   - What have others done? What have you and your team brainstormed for example? What has your process mapping exercise highlighted as problems?

At this stage it is about testing on a small scale. Consider, for example, using interviews with key stakeholders (including where appropriate patients). Also use volunteers and colleagues to test your ideas on. Find out what are their thoughts on your changes, will they work and will they be an improvement. As you are testing on a small scale, use only one location.

In the next step we will consider methods of evaluating your pilot study. Do you already know which evaluation tools you would use in your innovation – share your ideas via the comments section.

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This article is from the free online course:

Understanding Innovation in the Healthcare Sciences

Manchester Metropolitan University

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