Study Startup – Introduction

Study Startup
SECTION 1

Introduction

Contributors

Lynn DeBar, PhD, MPH

Jeffrey G. Jarvik, MD, MPH

Leah Tuzzio, MPH

Miguel Vazquez, MD

 

Contributing Editor

Liz Wing, MA

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.

Study Refinement Examples
Issue Adjustment
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 front-line 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.

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Citation:

Study Startup – Introduction: Study Startup – Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/startup-introduction/. Updated September 25, 2018.