The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jose R Maldonado, MD, Stanford University
ClinicalTrials.gov Identifier:
NCT01633424
First received: June 29, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition
Organ Transplantation.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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.

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Graft and patient survival [ Time Frame: Assessed at any given time post initial transplantation. ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: October 2011
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01633424

Locations
United States, California
Stanford Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: José R. Maldonado, M.D. Stanford University
  More Information

No publications provided

Responsible Party: Jose R Maldonado, MD, Associate Professor of Psychiatry; Chief, Psychosomatic Medicine Service, Stanford University
ClinicalTrials.gov Identifier: NCT01633424     History of Changes
Other Study ID Numbers: CR-02
Study First Received: June 29, 2012
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014