A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation

Completed

Conditions studied: Liver Diseases, Hepatocellular Cancer, Endstage Liver Disease, Liver Cirrhosis

In brief

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

Key facts

Study ID

NCT02073435

Run by

Northwestern University

People needed

177

Starts

2010-10-01

Expected to finish

2018-04-01

Last updated by the study team

2018-12-05

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• A. Clinicians
• Clinicians of both genders, of any race/ethnicity are included. Only clinicians who are unwilling to participate will be excluded.
• Clinicians and staff who are involved in the care of LDLT donors and recipients (e.g., nurses, surgeons, anesthesiologists, hepatologists, unit secretaries from medical and surgical units, ICU, transplant coordinators, pharmacists) at the four participating A2ALL Deux TCs.
• B. Patients
• Every donor (≥ 21 years) and recipient involved in LDLT at the four participating A2ALL Deux TCs between 2004-2015, who were enrolled into the A2ALL cohort study Un and/or Deux. (However, to date medical record reviews were only performed for patients involved in LDLTs 2008 or later. Observations were initiated in December, 2011). After enrollment of patients into the A2ALL Deux cohort study ends (anticipated May 2014), all LDLT donors and recipients at the four participating A2ALL Deux TCs will be approached for enrollment into this ancillary A2ALL R01 patient safety study.
• Patients have not been and will not be excluded on the basis of race, gender, or any other related characteristics.

You may not qualify if…

• No participants will be under 21 years of age. Patients will not be excluded on the basis of age, race, gender or any other non-employment related characteristics

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Columbia University — New York, New York, United States
• Virginia Commonweath University-Medical College of Virginia — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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