Pediatric Research in Office Settings PROS

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Pediatric Research in Office Settings (PROS)
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Introduction

• Four million births each year in U.S.
• Decreasing lengths of postpartum stay
• Responsibility for health promotion and
  monitoring shifts to outpatient
• Decision-making for readiness is complex

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Research Questions

• How often do mothers, pediatricians, and
  obstetricians agree on readiness for postpartum
  discharge?
• What influences these perceptions of readiness?
• How do these perceptions impact health care
  utilization, health outcomes, and health-related
  behaviors during the first four weeks after
  discharge?
• How do these perceptions change over time?

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Study Design

• Prospective observational cohort study
• 6,000 mother/infant dyads
• Followed for first 4 weeks after discharge

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Inclusion Criteria

• Term babies (37 weeks)
• Birth weight ? 5 pounds
• To be followed in PROS practices after discharge

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Exclusion Criteria

• Maternal chronic illness
• Twin or multiple birth
• Mother without a phone
• Infant in SCN ? 8 hours for medical reasons
• Major congenital anomaly
• Infants for adoption

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Data Collection Overview

• Demographics (1 practice form 1 for each
  clinician)
• Day of discharge questionnaires (mother,
  pediatrician, obstetrician)
• Daily diary for first 2 weeks post discharge
  (mother)
• Brief encounter form with each office visit
  (pediatrician)
• 4 weeks after nursery discharge (mother,
  pediatrician)

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LANDmarks (1)

• Practice Recruitment
• Study Coordinator
• Institutional Review Board at Hospital
• Mother Recruitment
• Hospital Obstetricians

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Practice Recruitment

• Demographic Questionnaire (1 per practice) and
  Practitioner Surveys (each clinician)
• Maximum participation 12 weeks
• Enrollment 8 weeks
• Follow-up 1 month
• 8 weeks enrollment or 40 - 60 dyads (whichever is
  first)
• Key questions for covering clinicians to minimize
  workload

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Study Coordinator

• Organize study materials at hospital(s) and
  office
• Implement study
• Mobile and Permanent Enrollment Logs
• Maintenance List
• Establish recruitment
• Monitor ALL study details

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Institutional Review Board (IRB) at Hospital

• Need local IRB approval letter prior to study
  start
• Local Principal Investigator (PI) required
• Local application necessary for expedited or full
  review
• AAP IRB materials available to "cut and paste
  into application

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Mother Recruitment

• Approach mothers during postpartum stay
• Record mother/infant dyads on Mobile Enrollment
  Log
• Have mother sign consent form
• Discuss mother's enrollment packet

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Hospital Obstetricians

• Engage OBs
• Personal contact
• Attend OB Dept. Meeting
• Complete Obstetrical Questionnaire (OBQ) on
  mother's day of discharge
• Endorsed by ACOG
• Quick to complete

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LANDmarks (2)

• Data Collection on Day of Nursery Discharge
• Hospital Nursery OB Floor
• Mothers at Home
• At the Practice/Health Center
• Incentives/Reimbursement

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Data Collection on Day of Nursery Discharge

• Mother completes enrollment questionnaire (MEQ)
• Discharging pediatrician completes
• initial questionnaire (PracIQ)
• Obstetrician completes obstetrical questionnaire
  (OBQ)

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Hospital Nursery OB Floor

• Mobile Enrollment Log - all eligible mothers
• Mother/infant dyad enrollment (LAND onesie)
• To be completed on day of discharge
• Obstetrical Questionnaire (OBQ)
• Practitioner Initial Questionnaire (PracIQ key
  questions for covering clinicians)
• Mothers Enrollment Questionnaire (MEQ)

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Mothers at Home

• Mothers Daily Diary (MDD) for 14 days post
  nursery discharge
• Mothers Follow-Up Questionnaire (MFQ)
• OB Postpartum Follow-Up Visit Postcard
• Mothers receive AAP parenting book upon completion

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At the Practice/Health Center

• Permanent Enrollment Log
• Maintenance List
• One reminder phone call to mother on day 1 - 2
• MFQ Reminder postcard at 3 weeks post-discharge
• Practitioner Encounter Questionnaire (PracEQ) to
  capture all visits
• Practitioner Follow-Up Questionnaire (PracFQ) at
  4 weeks post nursery discharge
• Reimbursement to defray expenses

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Incentives/Reimbursement

• Family incentives
• Newborn one-piece undergarment upon enrollment
• AAP parenting book upon completion of the
  Mothers Daily Diary
• Practice reimbursement
• 30 for each mother/infant pair enrolled with
  complete practitioner study materials (initial,
  encounter, follow-up questionnaires)

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LAND Study Funding

• Health Resources and Services Administration
  Maternal and Child Health Bureau (HRSA MCHB)
• AAP Friends of Children Corporate Fund
• AAP Friends of Children Research in Pediatric
  Practice Fund

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Visit LAND on the PROS Web Page

• For more information about the LAND Study, visit
  the PROS Web page.
• The PROS page is located on the American Academy
  of Pediatrics Web page at http//www.aap.org
• Click on Research, then click on PROS, then click
  on Life Around Newborn Discharge (LAND)

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For More Information About LAND...

• Please contact the PROS Central Office
• Phone [phone], ext 7626
• E-mail pros_at_aap.org

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