A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation

Summary

Living donor liver transplantation (LDLT), involves complex systems and processes of care that are particularly vulnerable to medical errors and preventable complications. This ancillary study of the Adult-to-Adult Living Liver Transplantation Cohort Study (A2ALL) will focus on conducting a proactive, systematic, and comprehensive assessment of the vulnerabilities in the systems and process of LDLT care to reduce medical errors and preventable complications thereby improving the safety of LDLT care. This project will address an important gap in the knowledge needed to achieve high quality and safe LDLT care of patients by developing a process to: 1) proactively, systematically and comprehensively identify areas of vulnerabilities in LDLT care that can result in medical errors, 2) design and implement solutions to mitigate these weaknesses, and 3) evaluate the effectiveness of these solutions to improve the safety of LDLT care by measuring clinical and process outcomes before and after solution implementation across four A2ALL participating transplant centers

Conditions

• Liver Diseases
• Hepatocellular Cancer
• Endstage Liver Disease
• Liver Cirrhosis

Interventions

BEHAVIORAL

Donor pain management

The evidence-based donor pain management solution entails the following elements: Preoperative Assessment and Management: * Assessment of Patient Risk factors for Respiratory Depression (e.g. OSA Assessment: STOP BANG Questionnaire) * Bowel preparation (e.g. Colace or Golytely) * Patient Postoperative Pain Education - Educational handout on postoperative pain At the end of the case in OR: * Local Anesthetic (TAP block, OnQ device, intrathecal, local infiltration) * I.V. Ketorolac (when adequate hemostasis is determined by surgeon and urine output is \> 500cc) * I.V. Steroids (Dexamethasone or Solumedrol) Postoperative Management: * NSAIDS x 72 hours followed by po cox-inhibitor until discharge (e.g. Celecoxib) * Opioids (Dilaudid PCA followed by oral opioids (e.g., Tylenol #3)) Postoperative Assessment: o CO2 monitoring in PACU/ICU for early monitoring of respiratory depression

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Daniela Ladner, MD MPH · Northwestern Univesity

• Donna Woods, PhD · Northwestern University

• Averell Sherker, MD · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2015-05-31

Completion

2018-04-30

Countries

• United States

Study Locations