A2ALL-Patients Safety System Improvements in Living Donor Liver Transplantation
Condition: Liver Diseases; Hepatocellular Cancer; Endstage Liver Disease; Liver Cirrhosis
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular; Liver Diseases; Liver Cirrhosis; End Stage Liver Disease
Study type: Observational

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
    

Detailed description: 
      This is an observational as well as a time-controlled study to be conducted at four
      participating A2ALL Deux Transplant Centers (TCs). The study is divided into three phases: an
      observational phase (Aim 1) to conduct a comprehensive and proactive patient safety risk
      assessment to describe preventable complications, near miss events, medical errors and
      hazardous conditions and in the delivery of standard of care to living donor liver transplant
      (LDLT) donors and recipients from the time of admission for the LDLT surgery through
      discharge after LDLT surgery. The in depth observational phase continues throughout the study
      and is scheduled to be completed by the end of the study (May 2015).

      In phase 2-solution development and implementation phase (Aim 2): two high priority areas of
      care were identified for in depth assessment and solution development. The selection of the
      two high priority areas of LDLT standard of care was guided by the identification of
      vulnerabilities in the systems and processes of care with a high incidence and severity of
      related preventable complications and medical errors across the four participating A2ALL Deux
      TCs. To date, multiple priority areas were identified, based on the ongoing review of medical
      records (e.g., transition of care, glucose control, donor pain management, preoperative OR
      set-up). The participating A2ALL Deux TCs agreed to focus on an in depth assessment of the
      two areas that demonstrated high incidence and high severity of preventable complications and
      medical errors: 1) donor pain management and 2) preoperative OR set-up process.

        1. Donor Pain Management:

           Upon further investigation, it was identified that living liver donors experience
           significant amount of pain, in the early postoperative period but also especially a few
           days after donation. Data from the four participating A2ALL Deux TCs reveal a 20%
           incidence, overall, of respiratory complications (e.g. re-intubation, requirement for
           application of Naloxone, etc.) directly related to the opioid use in the present LDLT
           standard of care for donor pain management. Based on these data, clinicians at the four
           participating A2ALL Deux TCs, in consultation with an international pain expert with
           particular expertise in transplantation (Paul White, MD University of Texas Southwestern
           Medical Center at Dallas, Dallas, Texas), developed an evidence-based donor pain
           management solution with the aim of reducing preventable complications as well as
           improving the donor pain experience. This evidence-based donor pain management solution
           was developed over months through in-person and telephone meetings of transplant
           surgeons, hepatologists, anesthesiologists and acute pain specialists from all four
           participating A2ALL Deux TCs, in addition to the research teams. Consensus has been
           reached on the key elements of the evidence-based donor pain management solution and all
           four participating A2ALL Deux TCs are poised to begin implementation.

        2. Preoperative OR Set-up Process:

      Preventable complications, near miss events, medical errors and hazardous conditions related
      to the preoperative OR set-up processes were identified. The four participating A2ALL Deux
      TCs will need to engage in additional review of the detailed assessment of the
      standardization and optimization of the preoperative OR set-up process and then, will
      collaboratively design a standardized process over a four month period (expected conclusion
      mid February 2014 in order to incorporate what occurs at the Collaborative at each site and
      overall). Solutions will be designed collaboratively to reduce the incidence and severity of
      related medical errors and preventable complications together with the TCs and their staff.

      The measurement of solution impact to reduce preventable complications and medical errors
      (Aim 3) involves the implementation of the two collaboratively developed solutions: (1)
      Evidence-based donor pain management solution and (2) Standardization and optimization of the
      preoperative OR set-up process. During this phase relevant metrics pre- and
      post-implementation will be compared to assess the effectiveness of the implemented
      solutions.
    

Intervention name(s): Donor pain management
Intervention type(s): Behavioral
Intervention description(s): 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
Observational model: Other
Time perspective: Other
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.
      
Keywords: liver transplantation; living donor; Safety