Clinical trial NCT01633424: The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)
Official title: The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT): Psychometric Characteristics of a New Scale for the Prediction of Post-transplant Psychosocial and Medical Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Transplantation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 217 Stanford Hospital and Clinics patients fulfilled our criteria of being transplanted with heart, liver, kidney or lung between 6/1/2008 and 7/31/2011 and having been evaluated with SIPAT.

Brief summary: Given the extremely limited availability of donated organs, transplant candidates must be carefully evaluated and selected to ensure the success of the transplant and value of the organ to the recipient. Medical criteria for pre-transplant evaluation of patients is well established, however, listing criteria for psychosocial risk factors (e.g., understanding of illness and transplant process, psychiatric history, support system, compliance, etc) is less standardized. The purpose of this research is to study the psychometric properties (e.g., predictive validity) of the new pre-transplant "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT) examination in patients who received heart, kidney, liver, or lung transplant and underwent the SIPAT evaluation before treatment. This new screening tool was designed to standardize the evaluation process of psychosocial risk factors and their severity, in order to enhance predictions of medical and psychosocial outcomes of patients post-transplant.

If the SIPAT is used for standard, pre-transplant assessment, risk factors that may be amenable to clinical intervention could be identified. In turn, this may assist in developing a comprehensive psychosocial treatment plan for each individual, with the ultimate goal of minimizing preventable problems, mitigating risk, and optimizing graft survival, patient function, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011 and underwent the SIPAT evaluation before treatment.

Exclusion Criteria:

* Patients identified through chart review who were transplanted with heart, kidney, liver, and lung between 6/1/2008 and 7/31/2011, who did not undergo the SIPAT evaluation before treatment.

Primary outcomes:
measure: Graft survival
timeFrame: Assessed at any given time post initial transplantation (up to 15 minutes to assess)
measure: Patient survival
timeFrame: Assessed at any given time post initial transplantation (up to 15 minutes to assess)
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Hospitals and Clinics
state: California
Study officials:
affiliation: Stanford University
name: José R. Maldonado, M.D.
role: PRINCIPAL_INVESTIGATOR
References: