A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Daniela Ladner, Northwestern University
ClinicalTrials.gov Identifier:
NCT02073435
First received: June 20, 2013
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention
Liver Diseases
Hepatocellular Cancer
Endstage Liver Disease
Liver Cirrhosis
Behavioral: donor pain management/ Pre-operative OR Set-up

Study Type: Observational
Official Title: A2ALL-Patients Safety System Improvements in Living Donor Liver Transplant

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Living Donor Pain Management [ Time Frame: Daily Visual Analogue Pain Scores (0-10) starting at transplant and throughout hospitalization (5-7 days). ] [ Designated as safety issue: Yes ]
    Comparison of Average Visual Analogue Pain Scores (0-10) measured before and after implementation of evidence-based donor pain management solution.


Estimated Enrollment: 3000
Study Start Date: October 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention Group
Living Donor Liver Transplant patients with evidence based donor pain management solution and Living Donor liver transplant patients after the Standardization and Optimization of the Pre-operative OR Set-up Process
Behavioral: donor pain management/ Pre-operative OR Set-up

The evidence-based donor pain management solution entails the following elements:Preoperative Assessment and Management (OSA assessment etc.); At the end of the case in OR (Local anesthetics etc.); Post operative Management (CO2 monitoring etc.)

Standardization and Optimization of the Pre-operative OR Set-up Process The four participating A2ALL Deux TCs will need to engage in additional review of the detailed assessment of the preoperative OR set-up process and will collaboratively design a standardized and optimized preoperative OR set-up solution to reduce the frequency of medical errors medical errors, resource wastage, and team burden and improve LDLT care (anticipated implementation February 2014).

Control Group

Living Donor Liver Transplant patients prior to the implementation of the evidence based donor pain management solution.

Living Donor liver transplant recipients prior the Standardization and Optimization of the Pre-operative OR Set-up Process


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

CLINICIANS: All clinicians who are involved in the inpatient care provided to the LDLT A2ALL donors and recipients are eligible for the study. The group of clinicians eligible for the study involve all clinicians participating in the LDLT care between day of surgery through discharge: OR personnel (nurses, technicians, anesthesiologists, surgeons, research staff, cell saver staff, etc.), PACU/Intensive Care Unit personnel (nurses, anesthesiologists, surgeons, pharmacists, etc.) and floor personnel (nursing, coordinators, pharmacists, etc.).

PATIENTS: Living Donor Liver Transplant patients (donor and recipients) from 2008-2015.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02073435

Contacts
Contact: Daniela Ladner, MD MPH 312-926-6543 dladner@nmh.org
Contact: Ella Reyes, MD MPH 312-503-4970 ella.reyes@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Ella Woods, PhD    312-503-4970    ella.reyes@northwestern.edu   
Principal Investigator: Daniel Ladner, MD MPH         
Principal Investigator: Donna Woods, PhD         
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Agnes Trabucco    781-744-3367    agnes.trabucco@lahey.org   
Principal Investigator: Elizabeth Pomfret, MD         
Principal Investigator: MaryAnn Simpson, PhD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Joe Pisa    312-305-3839    jp3279@columbia.edu   
Principal Investigator: James V Guarrera, MD         
United States, Virginia
Virginia Commonweath University-Medical College of Virginia Recruiting
Richmond, Virginia, United States, 23298
Contact: JoAnne L Davis    804-828-7921    jldavis4@vcu.edu   
Principal Investigator: Robert Fischer, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Daniela Ladner, MD MPH Northwestern Univesity
Principal Investigator: Donna Woods, PhD Northwestern University
Study Director: Averell Sherker, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided

Responsible Party: Daniela Ladner, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02073435     History of Changes
Other Study ID Numbers: A2ALL Safety Study, R01DK090129
Study First Received: June 20, 2013
Last Updated: July 18, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Northwestern University:
liver transplantation
living donor
Safety

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Liver Neoplasms
End Stage Liver Disease
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014