Polio Immunization Delivery Study (PIDS)

Protocol Overview

The PIDS study occurs in three phases.

Phase One:

The study participant and all other practitioners in the office who administer immunizations should complete the Practitioner Survey (gray copy for study participant; purple copies for non-participants).

Phase Two:

The study participant collects immunization data on a consecutive sample of 100 children, 8 to 35 months old seen by the study participant in one office site only. 1. At the time of a visit by an eligible child, a designated office coordinator should record the requested patient information onto the Office Study Log. At this point the child is assigned a unique patient identification number (Patient ID#). 2. The office coordinator then obtains verbal consent from the parent for the study and asks the parent to complete the Parental Study Form. This form is completed before or during the office visit. 3. After the visit, the child’s office medical record is reviewed; the office immunization summary sheet (sometimes called the Vaccine Administration Record or VAR) is photocopied. In addition, any VARs from other providers that are in the office medical record, and any newborn records that include a date for the first Hepatitis B immunization are also photocopied. 4. The last three digits of the child’s Patient ID# (ie, the digits in the shaded portion of the Office Study Log) are written on each of these photocopies, and all of the photocopied immunization records are attached to the enrollment envelopes containing completed Parental Study Forms. 5. The complete enrollment envelopes with attached immunization records are mailed to the PROS/NMA Immunization Study Center for data entry.

IMPORTANT NOTE: There is reimbursement for participation in this study! Practices will receive $300 upon completion of Phases One and Two.

Phase Three: (optional):

After a practice has begun Phases One and Two of the study, the study participant will receive information about the opportunity to participate in the optional third phase of PIDS. For this phase, participating practices will be eligible to have a team from a local Health Department come into their practice to review randomly selected medical records, enter immunization data into the Clinical Assessment Software Application (CASA) database, and calculate the practice immunization rate. Parents of children selected for the CASA survey will be contacted to complete the Telephone Questionnaire. Those practices completing the CASA survey and telephone follow-up portion of the study will receive an additional $200.