After feasibility and pilot testing, it may be necessary to adjust or refine the study design, intervention workflow, support processes, personnel, or study tools. As the study is conducted, assessment of contextual changes will be important, potentially leading to continued iterations of pilot testing or troubleshooting. It has been suggested that study teams assess their protocol and intervention workflow according to predefined study checkpoints (for example, after X number of patients enrolled or after X number of weeks in the study). Remember to build in flexibility to accommodate local conditions and changes over time. Below are a few examples of study refinements.
|Inadvertent patient crossover to intervention||The partner healthcare system had an issue of dynamic updating when a user opened a radiology report. Since randomization depended on calendar time in the stepped-wedge design, there was a potential for a single patient to cross over from the nonintervention group to the intervention group simply because the report was viewed at different times. The study team worked with site programmers to change the intervention insertion from dynamic to static so that it did not change depending on the viewing date.|
|Inadequate PRO collection||The study team had an expectation at the outset that adequate PRO data would be routinely collected and recorded in the EHR system. However, the team discovered after the trial began that they had to enhance support for PRO collection.|
|Intervention modification based on clinical practice limitations||The study team adjusted elements of the intervention delivery based on the availability of staff and limitations of the practice (such as physical therapists’ professional licensing limitations in working with a larger group of patients).|
|Incorrect patient enrollment lists||The partner healthcare system had initial problems with patient lists not distinguishing between potential candidates and those who were eligible and confirmed for enrollment. The study team put in place an additional manual confirmation by the practice facilitators.|
The startup phase involves ensuring that the elements of trial readiness have been completed before full site implementation begins. Activities during this phase may include:
- Finalizing the study documentation (see Documentation Checklist).
- Visiting each participating site/clinic/health system and completing the training of frontline clinicians and staff.
- Creating contingency plans for site dropout, inadequate enrollment, intervention contamination, EHR system changes, and potential turnover of healthcare system leadership, staff, or clinicians.
- Developing a study website with both public-facing and password-protected components.
- Ensuring that the study database is ready; developing a data status report template.
- Establishing a system whereby the study team can quickly verify that the intervention is being implemented as planned.
- Establishing a plan for ongoing communication/meetings with study teams, advisory board, and data monitoring committee.
Resources for Study Startup
The National Center for Complementary and Integrative Health (NCCIH) offers a Clinical Research Toolbox containing templates, sample forms, and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies.
The National Institute on Aging (NIA) provides a Clinical Research Study Investigator's Toolbox as an online informational repository for investigators and staff involved in clinical research.
Read more in the Living Textbook on Stakeholder Engagement Throughout the PCT Life Cycle.