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

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ClinicalTrials.gov Identifier: NCT01633424
Recruitment Status : Unknown
Verified August 2013 by Jose R Maldonado, MD, Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2012
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Jose R Maldonado, MD, Stanford University

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.


Condition or disease
Organ Transplantation.

Study Type : Observational
Estimated Enrollment : 600 participants
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.
Study Start Date : October 2011
Estimated Primary Completion Date : October 2016



Primary Outcome Measures :
  1. Graft and patient survival [ Time Frame: Assessed at any given time post initial transplantation. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013