Study Startup
Section 1
Introduction
After feasibility and pilot testing, it may be necessary to adjust or refine the study design, intervention workflow, support processes, personnel, or study tools. Ideally, pilot and feasibility testing should evaluate all planned trial procedures (identification of participants, random assignment within daily health care operations, consistent delivery of study interventions, and integrity/timeliness of data regarding primary outcomes). 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.
| Issue | Adjustment |
|---|---|
| Inadvertent patient crossover to intervention due to changes in electronic health records | This trial tested insertion of epidemiologic information into radiology reports regarding imaging for back pain. 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. Pilot testing revealed that PRO data were actually collected and recorded infrequently. Consequently, 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). |
| Incomplete information regarding eligible participants | 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 to identify concerns, identify logistical or practical barriers, and complete any necessary training of frontline clinicians and staff.
- Anticipating potential barriers and creating contingency plans for site dropout, inadequate enrollment, intervention contamination, EHR system changes, and potential turnover of healthcare system leadership, staff, or clinicians.
- Developing necessary tools for communication with study staff, health system staff, and potential participants (these may be similar or distinct, depending on specifics of study design and protocol).
- Establishing and testing procedures for collection of outcome data (including testing of assumptions regarding data recorded by health clinicians or other personnel).
- 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.
SECTIONS
NIH 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.
This Quick Start Guide is designed to provide some resources to project managers (PMs) to support the conduct of an embedded pragmatic clinical trial (ePCT) within their healthcare system.
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.
The National Center for Advancing Translational Sciences (NCATS) supports a broad range of clinical research tools that facilitate clinical trial design, patient recruitment, and regulatory compliance.
Living Textbook
Read about stakeholder engagement in study startup and throughout the ePCT trial life cycle.