PROS LAND Study
Protocol Overview

Study Overview at the Hospital(s)...

1. Identify eligible mother/infant pairs in one or more hospitals where newborns are seen every day during study enrollment, including weekends and holidays. Continue for eight weeks or until you have enrolled 40-60 pairs, whichever comes first.

2. Take Mother’s Enrollment Packets, newborn one-piece outfits, Obstetrical Questionnaire (ObQ), and blank Mobile Enrollment Log to the hospital(s) for study recruitment.

3. Present the study to the mother while she is in the hospital and obtain informed consent from mothers who agree to participate.

4. Enter all eligible mother/infant pairs on the Mobile Enrollment Log.

5. Give each enrolled mother a newborn "onesie" as a token of appreciation, and a Mother’s Enrollment Packet, which includes:

6. Place the Obstetrical Questionnaire in the mother’s chart for completion by her obstetrician on the date of hospital discharge.

7. Collect the completed Mother’s Enrollment Questionnaire from the mother on the day of hospital discharge.

Study Overview at Your Office...

1. For ALL eligible mother/infant pairs identified on the Mobile Enrollment Log, write the pair’s information on the LAND Permanent Enrollment Log, in either the participant section (next to the proper Patient ID#, as indicated by the Mobile Enrollment Log) or in the non-participant section.

2. Transfer the mother’s name and telephone number from the Mobile Enrollment Log to the Maintenance List.

3. Figure the one-day, three-week, and four-week post hospital discharge dates and record these on the Maintenance List. Use the baby's hospital discharge date as day zero.

4. Get the Practitioner Study Packet with the matching Patient ID#. Remove the Practitioner Initial Questionnaire (PracIQ) from the packet and have the practitioner who discharged the newborn complete it.

5. Place ALL 5 Practitioner Encounter Questionnaires (PracEQs) in the patient’s chart. Complete a PracEQ each time the patient is seen in the practice in the four weeks following discharge.

6. Affix a LAND sticker on the patient’s office chart.

7. Using the Maintenance List, call each mother one day following discharge to remind her to complete and return the Mother’s Daily Diary. If the mother does not return her completed diary by three-weeks post-discharge, send her a reminder postcard.

8. Four weeks following the baby's discharge from the hospital:

9. Check the Permanent Enrollment Log entry for each patient to indicate that the Practitioner’s Initial Questionnaire, Encounter Questionnaire(s), and Follow-Up Questionnaire have been completed. Review questionnaires for completeness and gather any missing data.

10. Mail completed study materials to PROS in the postpaid envelopes provided.

Participating Practices Will Receive...

Participating Mothers Will Receive...

 


Core support for the PROS network is provided by a grant from the Health Resources and Services Administration Maternal and Child Health Bureau

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Pediatric Research in Office Settings (PROS)
American Academy of Pediatrics
141 Northwest Point Blvd
PO Box 927
Elk Grove Village, IL 60009-0927
800/433-9016, ext. 7623