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OpenTrials
Completed

NCT Number: NCT02826460

Psychosocial Risks in Liver Transplant Recipients

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.

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Key information

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinia

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Rejection

    Time frame: 2 years

    Number of Rejections confirmed by biopsy

Secondary outcomes

  1. Medication Level Variability Index (MLVI)

    Time frame: 2 years

    MLVI is a measure of medication adherence

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Psychosocial Predictors of Posttransplant Adherence and Outcomes

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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