Clinical trial · Observational
A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation
A2ALL-Patients Safety System Improvements in Living Donor Liver Transplant
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endstage Liver Disease | — | UNRESOLVED | — |
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donor pain management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Post-Implementation Group
- description
- Living Donor Liver Transplant patients with evidence based donor pain management solution.
- interventionNames
- Behavioral: Donor pain management
- label
- Pre-Implementation Group
- description
- Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.
Primary outcomes (2)
- measure
- Living Donor Pain Management
- timeFrame
- Daily Visual Analogue Pain Scores (0-10) At transplant (post-operative day 0) and throughout hospitalization (post-operative days 1-8)
- description
- Comparison of Average Pain Scores on Visual Analogue Pain Scale (0-10) measured before and after implementation of evidence-based donor pain management solution. 0 representing "No Pain", up through 10 representing "Worst possible, unbearable, excruciating pain".
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: A. Clinicians 1. Clinicians of both genders, of any race/ethnicity are included. Only clinicians who are unwilling to participate will be excluded. 2. 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 1. 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. 2. Patients have not been and will not be excluded on the basis of race, gender, or any other related characteristics. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available