National Deceased Donor Potential Study: Updates and Next Steps

Acknowledgement: The Deceased Donor Potential Study is a commissioned study funded by the Organ Procurement and Transplantation Network (OPTN) under Task 6 of the existing contract. The OPTN is supported by Health Resources and Services Administration (HRSA), Healthcare Systems Bureau, Division of Transplantation’s contract #234-2005-370011C. The content described here is the responsibility of the author alone and does not necessarily reflect the views or policies of the Department of Health and Human Services, the OPTN, or UNOS; nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.

The “Question”

What is the “true” potential for deceased organ donation in the United States?

Purpose of Study

The DDPS aims to generate more current scientific evidence that is based on rigorous epidemiologic, population, demographic, and geographic analyses of the deceased donor system for the purposes of determining the potential number of organ donors, and to determine the potential trend in that number over time.

Specific Aims: Objectives

Research Strategy

Build a unifying framework for understanding deceased donor potential, linking existing bodies of knowledge and specific research traditions that are relevant to transplantation WITH the power of transdisciplinary science approach.

Examine deceased donor potential from a complex system view.

Important Qualifiers or Clarifying Points about the Study

What the study is not:Does not include OPTN policy formation and analysis.Does not include any focus on organ allocation or

distribution.Does not include any recommendations on differing

geographic units of measure or operational approaches.Study is not focused on current understandings or

classifications typically used for compliance reasons (ECD, SCD, etc.).

Deceased Donor Potential Study: 3 Threads

DDPS : Expert Group that Informs this WorkThe Committee The SubcommitteesDDPS Stakeholder Committee is comprised of transplant and non-transplant professionals (50 members)

•Critical Care, Neuro, Trauma, Emergency Medicine•OPO Professionals (Executives, Directors of Procurement, Clinical Operations, Communications, Quality Improvement) •Transplant Surgeons and Physicians, Transplant Nurses•Other Subject Matter Experts—Geography, Epidemiology, Economics, Health Services Research, Statistics, System Dynamics, and Human Subjects Protection•Transplant Recipient and Citizen Participant•HRSA•CMS•AHA

OPO Subcommittee

Data Subcommittee

Caregiver Informant Group Subcommittee

System Dynamics Work GroupEvidence-Based Review SubcommitteeOpen Innovation Subcommittee

Deceased Donor Potential StudySubcommittee Contributions

Evidence-based Review

OPO Subcommittee

DataSubcom System Dynamics

Team

Open Innovation

Caregiver Informant

Group

Inside the Mortality Funnel: Path from All Deaths to Deceased Donors

1. All Deaths2. All Medically Suitable Deaths

3. Donors

Source: Adapted from T. Beigay, M. Reibel, & J. Rosendale, 2011.

*Note: Graphic is not drawn to scale.

Data source triangulation for Donor Potential Number

• The CIG, OPO, and Data Subcommittees will collaborate to provide three different estimates of donor potential using different databases and similar filters

• This range of estimates will also be used in the System Dynamics Deceased Donor Potential model

Data Source OptionsData Source Strengths Limitations DDPS Project Utility

National Mortality Data NVSS

Includes all deaths Not coded for all medical exclusionary criteria

Use for Deceased Donor Potential Estimate #1

National Hospital HCUP

Includes all medically relevant exclusionary criteria

Includes only deaths occurring in hospitals; No COD data

Use for Deceased Donor Potential Estimate #2

OPO Medical Record Reviews

Includes medically relevant criteria

Disparate, non-standard formats

Time required not available

OPO Call Center Records

Rich source of qualitative data

Will not provide deceased donor potential per se

Time required not available

California Mortality Data

Includes complete, identified mortality data allowing linking to UNOS database; 10-yr series

Includes only California deaths

Use for Deceased Donor Potential Estimate #3 and Gap Analyses

Donor Potential Estimate #1

1. AllDeaths

2. All Medically Suitable Deaths

3. OPTN Database

4. OPTN Donors

Custom Criteria

for Filter

Donor Potential Estimates #2 & #3

1. AllDeaths

2. All Medically Suitable Deaths

3. OPTN Database

4. OPTNDonors

Custom Criteria for Filter

Proposed Procedure for Developing and Applying Custom Criteria for Medical Suitability for Deceased

Donation

Synthesize and Operationalize

Criteria Within the Constraints of Available Data

(Data Subcommittee)

Criteria from OPO Leaders and Procurement Professionals

(OPO Subcommittee)

Criteria from Clinicians and

Caregivers(CIG Subcommittee)

Goal: Apply Custom Filters to Datasets

Donor Potential Gap Analysis: Actual v. Potential

• Build comprehensive dataset (includes NCHS and California’s Death Statistical Master files match-merged with OPTN Deceased Donor data + Census data)

• Conduct comparative donor gap analyses

• Use logistic regression models to determine probability of1. Donation if eligible2. OPTN Database - if

medically suitable3. OPTN Donor- if medically

suitable

1. AllDeaths

2. All Medically Suitable Deaths

3. OPTN Database

4. OPTNDonors

Gap 1

Gap 2

Gap 3

Validation/calibration

Donor Policy Projections

End StageChronicdisease

Waiting ListTransplantRecipients

Deaths

TransplantRate

TransplantProgram Capacity

Donor OrgansAvailable

Donors

Organs perDonor

Outcomes

Graft Failure

RiskTolerance

What if …

• What policies are most effective to increase donation and increase realization of deceased donor potential?

Successful Transplants per year

Updates

Key Milestones

Next Steps and Actions

July July/August September 2012

Acknowledgements

The Stakeholder CommitteeAlexandra K. Glazier, Esq.Betty C. Crandall, MS, RNDanielle L. Cornell, RN, BSN, CPTCDavid G. Jacobs, M.D.David W. Bosch, MSDavid H. Howard, Ph.D.Dorothy L. Faulkner, M.P.H., Ph.D.George F. Bergstrom, MA, FACHE Gerard Rushton, Ph.D.Glen Franklin, M.D.Harry E. Wilkins, III, M.D., MHCM, FACSHazhir Rahmandad, Ph.D.Howard M. Nathan, BS, CPTCJ. Elizabeth Tuttle-Newhall, M.D.James J. Wynn, M.D.Janice Whaley, MPH, CPTCJeffrey P. Orlowski, MS, CPTCJennie P. Perryman, RN, Ph.D.Jesse Schold, Ph.D., M.Stat., M.Ed.John Belcher, BS, CCEMT-P, CPTCJulie A. Mayglothing, M.D.Karen Garcia, M.S.Ed.Kevin J. O'Connor, MS,PALaurie J. Lyckholm, M.D.

Linda Ohler, MSN, RN, CCTC, FAANLori E. Markham, RN, MSN, CCRN, CPTCM. Anjali Sastry, Ph.D.Marcella Farinelli Fierro, M.D. Maria DeLauro, RN, MSN,MPAMary Kelleher-Crabtree, MS, PMP, CIP, CCRPMaryl R. Johnson, M.D.Meg M. Rogers, BSN, CPTCNikolaos T. Pyrsopoulos, M.D., Ph.D.P.J. Geraghty, EMT-P, BS, CPTCPaul K. Halverson, Dr.P.H., M.S.H.A, FACHERenee Bennett, RN, BSN, CNOR, CCTN, CCTCRichard D. Hasz, Jr., MFSRobert S.D. Higgins, M.D., MSHAStuart J. Youngner, M.D.Suzanne Lane Conrad, RN, MSThomas Mone, MSThomas A. Nakagawa, M.D.Thomas P. Bleck, M.D., FCCMTimothy L. Pruett, M.D.Richard Durbin, MBA Christopher J. McLaughlinTeresa M. Beigay, Dr.P.H. Brian Shepard

The Research TeamName and Organizational Affiliation Role on Team

Darren E. Stewart, M.S. (UNOS Research) Data Analyst, CIG Support

David A. Wagstaff, Ph.D. (Penn State) Data Analyst, CIG Support

Gary King, Ph.D., M.A. (Harvard) Co-Investigator

John D. Rosendale, M.S. (UNOS Research) Co-Investigator

Joyce D. K. Essien, M.D., M.P.H. (Emory, CDC-Retired) Facilitator

Kevin A. Myer, M.S.H.A. (UNOS CTSE) Co-Investigator

Khalid Saeed, Ph.D., M. Eng. (WPI) Co-Investigator

Kristina Wile, S.M. (Systems Thinking Collaborative) Facilitator, Project Management

Laura A. Siminoff, Ph.D., M.A. (VCU) Co-Investigator

Leah B. Edwards, Ph.D. (UNOS Research) Co-Investigator

L. Ebony Boulware, M.D., M.P.H. (Hopkins) Co-Investigator

Michael Reibel, Ph.D. (Cal Poly) Co-Investigator

Samuel Soret, Ph.D., M.P.H. (Loma Linda U) Co-Investigator

Gary B. Hirsch, S.M. (Creator of Learning Environments and MIT) Co-Principal Investigator

Karl J. McCleary, Ph.D., M.P.H. (UNOS CTSE and VCU) Principal Investigator

Center for TransplantSystem Excellence

Improving the care continuum