Psychosocial Risks in Liver Transplant Recipients

End Stage Liver Disease Clinical Trial

Official title:

Psychosocial Predictors of Posttransplant Adherence and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826460
• Other study ID #: GCO 14-1874
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: July 5, 2016
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinia	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Rejection	Number of Rejections confirmed by biopsy	2 years	Yes
Secondary	Medication Level Variability Index (MLVI)	MLVI is a measure of medication adherence	2 years	No