From the NICU to Primary Care: Improving the Quality of the Transition

1. From the NICU to Primary Care:Improving the Quality of the Transition Virginia A. Moyer, MD, MPH Professor of Pediatrics, Baylor College of Medicine Chief, Section of Academic General Pediatrics Chief Quality Officer, Medicine Texas Children’s Hospital

2. Cartoon:

3. Overview • Care transitions • Patient safety challenge • Literature • HFMEA™ • Definition • Description • AHRQ Planning Grant • NICU to ambulatory follow-up • Process • Results • HFMEA™ • Qualitative • Next steps

4. Background • Patient Safety literature increasingly acknowledges potential risks of care transitions • Adult literature reveals significant vulnerabilities • Proactive evaluation of error-prone health care processes can inform interventions to prevent adverse patient outcomes before they occur

5. Care Transitions Sometimes called “handoffs” Movement of patients between health care practitioners and settings Shift changes ER to hospital OR to post-op or ICU ICU to floor One facility to another

6. Hospital to Home Prolonged time period during “handoff” Unclear lines of responsibility Lack of patient understanding of health care problems Lack of readiness for self-care responsibilities Lack of information for follow-up provider

7. Pediatric Care Transitions • Inpatient to ambulatory setting • Pediatric literature relatively silent except for measuring follow-up appointments • Focus has been on “lack of compliance” by caregivers rather than on systematic issues around discharge • 28% of children discharged from a pediatric ICU (not a NICU) did not receive timely medical follow-up McPherson ML, Lairson DR, Smith EO, Brody BA, Jefferson LS. Noncompliance with medical follow-up after pediatric intensive care. Pediatrics 2002;109(6):94.

8. Research in Adults 19% of patients had identifiable adverse events in the first 3 weeks home 73% of older patients misused at least one medication >1 medical error per discharge summary

9. Research in the NICU What to do?

10. FMEA: Failure Mode and Effects Analysis

11. What is a FMEA?“The technique involves identifying potential mistakes before they happen to determine whether the consequences of those mistakes would be tolerable or intolerable” Potential failures are identified in terms of failure “modes” For each mode the effect on the total system is studied.

12. Why FMEA? Powerful approach for proactive risk assessment Used in other high risk industries such as aerospace, aviation, nuclear industry

13. HFMEA™ Process • Team generates a flow diagram of main process and sub-processes • Team brainstorms about all potential errors at each step (failure modes) • Each is scored for probability it will occur (frequency) and potential severity if it did occur (severity) • Frequency score x severity score = hazard score • High-risk failure modes identified as well as related causes or contributory factors DeRosier J, Stalhandske E, Bagian JP, Nudell T. Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system. Jt Comm J Qual Improv. 2002 May;28(5):248-267, 209.

14. AHRQ Planning Grant • Conduct HFMEA on NICU to ambulatory care transitions • Conduct retrospective review to confirm or modify HFMEA findings • Conduct qualitative assessment of the process to accomplish the HFMEA

15. Setting: Texas Children’s Hospital • NICU • 78 Level III beds, 62 Level II beds • >200 VLBW (<1500gm) babies per year, many other babies with complex congenital abnormalities • Special Needs Primary Care Clinic • Housed at main campus • >100 children on home ventilators; 24-7 coverage • TCPA • 42 private practices, including 5 Medical Homes • Shared electronic record with TCH • TCHP • TCH-owned Medicaid Managed Care Plan, ~230,000 kids

16. Our Project Perform a HFMEA for the transition in care from NICU to ambulatory follow up Use multiple methods to see if our predictions are correct Revise the HFMEA Develop a mitigation plan to address the identified risks

17. It takes a team… Virginia Moyer, MD, MPH – Principal Investigator Karen Finkel, RN, BSN – Patient Safety Office Hardeep Singh, MD, MPH – Patient Safety Researcher (VAH) Lu-Ann Papile, MD – Neonatologist Jochen Profit, MD – Neonatologist Charleta Guillory, MD – Neonatologist Marcia Berretta, MSW – Social Worker Teresa Duryea, MD – Pediatrician Lori Sielski, MD – Pediatrician Jan Mort, RN – Baylor NICU nurse Carol Carrier, RN Adam Kelly, PhD – Survey researcher (VAH) Myrna Khan, PhD – Patient Safety researcher (VAH) Eric Thomas, MD, MPH – Patient safety guru (UT-H) Joseph DeRosier – creator of HFMEA (VAH)

18. Process Diagram

19. NICU to Ambulatory Care Diagram

21. Our HFMEA™ Results • Team identified 114 potential failure modes within the discharge process • Final model included 40 high-failure modes and 75 high-risk causes

22. HFMEA™ Results • Common issues present across most failure modes and causes: • Clinicians act in isolation resulting in lack of standardized, coordinated, comprehensive plan of care • Parents/caregivers inadequately prepared for home care and management of fragile infants • Community providers lack required knowledge and skills to manage medically complex infants

23. “Multiple Methods” to confirm the HFMEA Self-reporting of events (using TCH reporting system) Electronic triggers for possible adverse events ER visits within one month of discharge Readmissions within one month Missed appointments within one month Questionnaire for parents/caregivers the “Care Transitions Measure”

24. Retrospective Review • Charts reviewed using a trigger methodology to confirm or add to HFMEA findings (N=88) • Failures documented for 14 of 35 sub-steps predicted to have errors, in 1-10 cases each • Documentation in current medical records system inadequate to systematically collect reliable data • Documentation unavailable for majority of patients for 19 of the 35 sub-steps. • A pediatric-adapted “care transitions measure” developed and validated.

25. Qualitative Analysis of the HFMEA Process • The team members felt that the group functioned extremely well, with a high level of involvement and many new insights gained in the process. • The team encountered difficulty applying the HFMEA scoring system to the identified failure modes • The severity descriptions did not seem to fit the types of failure modes identified • Frequency descriptions did not seem sufficiently granular • The group modified both descriptions before it proceeded with scoring. • Some group members were concerned that scoring severity and frequency at the same time allowed for “gaming” of the scores • At the end of the process, the group scored one set of failure modes independently to determine whether this would significantly alter the scores (it did not).

26. Safe Passages • The final step of the HFMEA is the development of a mitigation plan • We addressed the three major themes that were identified in the HFMEA: • Lack of a standardized discharge plan • Inadequate parent/caregiver preparation • Lack of knowledge and skills by community-based health care providers

27. Safe Passages • We based the intervention on the Care Transitions Intervention (Coleman et. al.), adapted for a pediatric population. • Enhanced Personal Health Record • Health Coach • Just In Time Information for community-based health care providers

28. Enhanced Personal Health Record • Existing discharge plan is ad hoc • Existing standard discharge information limited to a single sheet of paper with diagnoses, medications and appointments written in by hand. • Note that for many of our babies, the paper chart weighs more than the baby.

29. Enhanced Personal Health Record • Welcome, Helpful Information about the Newborn Center, and Important Numbers • Journaling and Care Pages • Tips for Choosing Insurance and Pediatrician for Your Baby • Resources and Support • Ronald McDonald House • Key People, Equipment and Medical Terminology Glossary • Your Baby’s Development, Nutrition, and Feeding • Premature Babies Immunization Schedule • Breastfeeding Your Baby • Newborn Feeding- Bottle Feeding and Formula Preparation • Safety and Education • Medication Safety • Giving Oral Medicines • How to Give a Subcutaneous Injection • Crib Safety • Signs and Symptoms of Illness • Crying • Colic • Preventing Infection • RSV • Synagis • Planning for Discharge Checklist • Calendar with Follow-Up Appointments

30. Health Coach • A technically expert individual who takes the role of sensitive coach, teacher and facilitator to foster the development of parents into competent caregivers for their fragile infants. • Master’s prepared health educator, available at the hours parents are able to be present in the NICU. • Available to staff as a resource person

31. Just-in-Time information for primary care providers • Capitalized on new Evidence Based Guidelines program at Texas Children’s • One page summaries of evidence based guidelines for common problems • Transition from premature formula, oxygen weaning, growth of premature infants, management of gastrostomy, management of tracheostomy, chronic lung disease… and much, much more. • Sent home with infant and also faxed to provider at the time of discharge

32. Research Design • Concurrent Cohort Study over 1 year • NICU is divided into geographically distinct “pods” • One NICU III pod and its usual step-down Level II pod comprise the intervention group • Other pods comprise the control patients • IRB did not require patient/parent consent beyond verbal consent at the time of enrollment • But did require written consent for the evaluation of PCP compliance with JIT protocols

33. Progress to date • Recruitment of intervention babies is close to on-schedule (n~50 at 6 months) • Recruitment of control babies is behind (n~40) because 2 control units were closed for low census • Very few refusals to participate, very high rate of response to phone surveys • Moderate level of difficulty recruiting PCPs to the J-I-T intervention, so numbers are low.

34. Outcome Evaluation • Primary outcome is adverse events within 31 days of discharge (death, ER visit, readmission, missed appointments) • Care Transitions Measure – Neo: administered by phone 2-3 days after discharge and again at 31 days • Comfort level and satisfaction of PCPs with common post-NICU problems • Adherence to guidelines by PCPs

35. Deliverables • Toolkit • Manual for the Health Coach • Enhanced Discharge Binder (to be converted to electronic format if and when our EMR implementation actually happens) • JIT information sheets (to be converted…) • CTM-Neo - validated tool to evaluate the quality of the NICU discharge experience

36. References The Care Transitions ProgramSMhttp://www.caretransitions.org accessed January 18, 2007. Coleman EA, Berneson RA. Lost in transition: Challenges and Opportunities for improving the quality of transitional care. Ann Int Med. 2004 Oct 5; 141(7):533-536. DeRosier J, Stalhandske E, Bagian JP, Nudell T. Using health care Failure Mode and Effect Analysis: the VA National Center for Patient Safety's prospective risk analysis system. Jt Comm J Qual Improv. 2002 May;28(5):248-267, 209. Forster AJ, Clark HD, Menard A, et al. Adverse events among medical patients after discharge from hospital.  CMAJ. 2004; 170:345-349.    McPherson ML, Lairson DR, Smith EO, Brody BA, Jefferson LS. Noncompliance with medical follow-up after pediatric intensive care. Pediatrics 2002;109(6):94. Moore C, Wisnivesky J, Williams S, McGinn T. Medical errors related to discontinuity of care from an inpatient to an outpatient setting. J Gen Intern Med. 2003 Aug;18(8):646-51. Philibert I. Leach DC. Re-framing continuity of care for this century. Qual Saf Health Care. 2005 Dec;14(6):394-396. Roy CL, Poon EG, Karson AS, Ladak-Merchant Z, Johnson RE, Maviglia SM, Gandhi TK. Patient safety concerns arising from test results that return after hospital discharge. Ann Intern Med. 2005;143(2):121-8.

37. Questions?