Pilot studies will be conducted throughout the life of the National Children’s Study as new issues
and challenges arise, and will encompass the questions that must be addressed to enable a functional and cost-effective Study. As results from the pilot studies become available, they will be incorporated into the research design.
The National Children’s Study is planning to expand the scope of activity of the Vanguard Study in order to accelerate development and deployment of the Main Study. The goals are to evaluate alternative strategies for recruitment, Study visit assessments, and Study logistics and operations.
Three additional recruitment pilot strategies are being developed for implementation during this expanded Vanguard Study, which will retain the current National Children’s Study locations. The new strategies include:
- Provider-based Recruitment
- Enhanced Household-based Recruitment
- High Intensity/Low Intensity Dynamic Model
Provider-based Recruitment
Provider-based recruitment will utilize health care providers as broadly defined to include state licensed practitioners that are in contact with women who are or may become pregnant. Providers may include, but are not limited to, obstetricians, gynecologists, family practitioners, internists, pediatricians, other medical specialists and subspecialists, midwives, public health nurses, or other professionals in a public health clinic setting. The strategy will use individuals or locations where health care services are provided as a primary point of contact and to provide information about the National Children’s Study.
Enhanced Household-based Recruitment
Enhanced household-based recruitment will utilize field workers who enter the predefined geographic segments and contact individuals and families at their residence. The strategy is similar to the strategy currently in use by the initial seven Vanguard Centers, but will be enhanced through application of best practices from the current experience; targeted marketing campaigns; enhancement of additional sources of referral into the Study, such as health care providers, social clubs and organizations, and public events; and streamlined enrollment procedures.
High Intensity/Low Intensity Dynamic Model
The High Intensity/Low Intensity Dynamic Model will use marketing, direct mail, and other referral techniques to enroll a broad-based population in additional larger geographic areas, such as complete zip codes beyond the predefined geographic segments, into a Low Intensity National Children’s Study. The Low Intensity National Children’s Study will provide participants with Web-based, mail-in, or telephone-based brief questionnaires on a periodic basis. From the pool of participants in the Low Intensity National Children’s Study, those living in the predefined geographic segments will be invited to participate in the High Intensity National Children’s Study, which will follow the protocol-based planned Study visit schedule that includes home and clinic visits. If participants leave the High Intensity National Children’s Study or decline further participation, new participants from the Low Intensity pool can be added dynamically.
With the re-direction of the Vanguard Study, there are now two formalized types of methods development studies to occur during the Vanguard phase for the purpose of informing the Main Study regarding methodological issues:
- Substudies: Focused studies supporting the Vanguard phase, which are initiated by the
Program Office and funded by the National Children’s Study, but may be developed outside of the Program Office and will generally be implemented at Study locations.
- Supplemental Methodological Studies: Focused studies supporting the Vanguard phase, which are initiated, developed, and funded outside of the Study protocol planning efforts, and which generally will be implemented at Study locations.