Psychosocial Risks in Liver Transplant Recipients

Psychosocial Predictors of Posttransplant Adherence and Outcomes

A retrospective chart review in which the information in the standard psychosocial evaluations done pre-transplant for liver transplant recipients will be coded, recorded, and correlated with posttransplant outcomes of the same recipients. Evaluated outcomes include rejection episodes and adherence to tacrolimus, calculated through the MLVI (Medication Level Variability Index). The researchers will evaluate the degree to which both single elements in the evaluation as well as a cumulative score derived by a structured review of the chart using the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) model can predict posttransplant outcomes.

Study Overview

• Status: Completed
• Conditions: End Stage Liver Disease

Detailed Description

The research team will perform a chart review and extract data without identifiers from paper charts and electronic charts and data tracking system. This data will be obtained from OTTR /EPIC as well as paper charts if needed. Those charts will be accessed to obtain demographic data (age, gender, income, employment status, marital/relationship status, insurance payer); transplant specific data (primary diagnosis, transplant year, tacrolimus blood levels, rejection episodes (yes/ no and number of), graft loss (yes/no), re-transplantation (yes/no); related medical data (creatinine levels, dialysis dependence (yes/no), ICD diagnoses; and psychosocial variables (social worker risk assessment before transplant, presence of social and family support, conviction history (yes/no), psychiatric history (diagnoses yes/no).

Variables will be obtained from the psychosocial pretransplant evaluation write-up (which in different years was attached to OTTR or EPIC datasets, or may be present in paper form, and from electronic datasets (OTTR / EPIC).

The data extraction as well as dataset building and data entry will be performed in office spaces at ISMMS. No patient contact is anticipated for this study. The predictive model will include evaluations of single variables as well as an evaluation of the predictive ability of a pre-defined scoring system (the SIPAT) which will be applied to existing data.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients whose information is available to RMTI, who received a liver transplant in the year 2012 or earlier, who received tacrolimus, and who had at least 3 tacrolimus blood tests, are eligible.

Description

Inclusion Criteria:

• Received a liver transplant in the year 2012 or earlier
• Received Tacrolimus
• Had at least 3 Tacrolimus blood tests
• Received their transplant at RMTI

Exclusion Criteria:

• Patients who received more than 1 solid organ transplant
• Patients who were not prescribed Tacrolimus
• Patients who died within the first year after transplant
• Patients with cognitive impairment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Liver Transplant Recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Rejection	Number of Rejections confirmed by biopsy	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Level Variability Index (MLVI)	MLVI is a measure of medication adherence	2 years

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 5, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Adherence; Transplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: GCO 14-1874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No