Clinical trial NCT02826460: Psychosocial Risks in Liver Transplant Recipients
Official title: Psychosocial Predictors of Posttransplant Adherence and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Liver Disease
Keywords: Transplant
Adherence
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Rejection
timeFrame: 2 years
Secondary outcomes:
measure: Medication Level Variability Index (MLVI)
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinia
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eyal Shemesh, MD
role: PRINCIPAL_INVESTIGATOR
References: