A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation

NCT02073435 | Completed Results DMC

• 2 other identifiers: A2ALL Safety StudyR01DK090129
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

liver transplantation; living donor; Safety

Outcome Measures

Primary Outcomes (2)

• Living Donor Pain Management

  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".

  Daily Visual Analogue Pain Scores (0-10) At transplant (post-operative day 0) and throughout hospitalization (post-operative days 1-8)

• Complications

  Cardiopulmonary complications

  Perioperatively

Study Arms (2)

Post-Implementation Group

Living Donor Liver Transplant patients with evidence based donor pain management solution.

Behavioral: Donor pain management

Pre-Implementation Group

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

Interventions

Donor pain management BEHAVIORAL

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

Post-Implementation Group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Virginia Commonweath University-Medical College of Virginia

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Liver Diseases; Liver Neoplasms; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was originally intended to be a clinical trial, with control and intervention sites, however, per discussions with the NIDDK program officer the study design was changed to a observational study.

Results Point of Contact

• Title: Donna Woods, MD
• Organization: Northwestern University

woods@northwestern.edu

312-503-5550

Study Officials

• Daniela Ladner, MD MPH

  Northwestern Univesity

  PRINCIPAL INVESTIGATOR

• Donna Woods, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Averell Sherker, MD

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: February 27, 2014
• Study Start: October 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: April 1, 2018
• Last Updated: December 5, 2018
• Results First Posted: December 5, 2018

Record last verified: 2018-11

Locations

US (4)