December 23, 2009
As described on the teleconference held December 10, 2009, 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 (1) alternative strategies for recruitment, (2) Study visit assessments (those events and assessments that are scheduled during Study visits), and (3) Study logistics and operations. This announcement focuses on recruitment strategies and subsequent announcements will address the other topics.
Three additional recruitment strategies are being developed for implementation during this expanded Vanguard Study at current Wave 1 and Wave 2 Study locations. The new strategies include:
- Provider-based Recruitment
- Enhanced Household Recruitment
- High Intensity/Low Intensity Dynamic Model
As we are seeking to ensure geographic regional and demographic diversity, all Wave 1 and Wave 2 Study locations are eligible for inclusion in one of the new recruitment pilots. Each strategy will retain the current National Children’s Study locations (or Primary and Secondary Sampling Units). We recognize that the segmentation process for some of the Wave 1 Study locations is ongoing and has not yet begun for most of the Wave 2 Study locations. We are developing a plan to facilitate the segmentation process in each of these areas. Study locations selected for inclusion in the alternative recruitment pilot studies will have priority for completing their segmentation tasks.
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. Options include placing Study related personnel in health care delivery locations, training health care providers in recruitment approaches, installing informational material, or combinations or other additional methods. Only women who reside in the predesignated geographic segments would be eligible. No new sampling frame will be defined on the basis of the location of the health care provider or the scope of the practice or cachement area. This strategy will not use household based recruitment.
Enhanced Household 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. The characteristics of current best practices have not yet been defined but will be provided in a structured manner in advance of detailed planning for the field work. For purposes of the Letter of Intent, assume a set of best practices will be available as a resource.
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 approach is similar in concept to the U.S. Census Short Form and Long Form or the Canadian Longitudinal Study on Aging. The Low Intensity National Children’s Study will provide participants with Web-based, mail-in, or telephone-based brief questionnaires on a periodic basis. The interval between questionnaires is currently projected to be every 6 months, but different options are plausible. 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. In addition, subpopulations that may have higher attrition rates or have other characteristics of interest may be oversampled. The sample size target for the High Intensity participants remains the same as for the other recruitment strategies of 100,000, so if this model were to be scaled up, the total pool of participants in the National Children’s Study would be in excess of 100,000.
To be considered a candidate to evaluate one or more of these recruitment strategies, please prepare a Letter of Intent that describes your interest and priority in participating in any or all of the described recruitment strategies for each National Children’s Study location served by your Center that you wish to be considered. Please submit a separate letter for each combination of location/methodology. For example, a Center proposing to conduct provider-based and household recruitment in two locations would submit four letters of intent. Each letter is limited to five pages in length. Describe your proposed approach to the task(s), highlighting key sociodemographic considerations and the geographic locations of interest. No formal budget should be submitted at this time; however, descriptions of cost effective implementation plans that include estimates of the general number and types of personnel and estimated level of effort are encouraged. All letters of intent must be submitted by e-mail to the NCS@mail.nih.gov mailbox no later than 8:00 p.m. Eastern Standard Time on Wednesday, January 20, 2010. Successful candidates will be selected on the scientific, logistical, and operational quality of the proposal with consideration for factors such as geography and demographics.
Time and resources for preparation of the Letter of Intent are not billable to the National Children’s Study as this is a voluntary effort and not a required task issued under any existing contract. Any questions should be addressed in writing to NCS@mail.nih.gov.