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Social & Contextual Impact on Children Undergoing Liver Transplantation (SOCIAL-TX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04551742
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 5, 2021
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant.

Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.

Condition or disease
Liver Transplantation Liver Diseases

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Social & Contextual Impact on Children Undergoing Liver Transplantation
Actual Study Start Date : September 16, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization [ Time Frame: 90 Days ]
  2. Episodes of acute cellular rejection [ Time Frame: 1 Year ]
  3. Ideal Outcome-3 (IO-3) [ Time Frame: 3 Years ]
    The ideal outcome measure is a composite measure of morbidity after transplant defined as alive, ALT and GGT <50, normal GFR, no non-liver transplants, no cytopenias, and no PTLD.

Secondary Outcome Measures :
  1. Readmission within 90 days after transplant [ Time Frame: 90 Days ]
  2. Episode of biopsy-proven acute cellular rejection within 90 days after transplant [ Time Frame: 90 Days ]
  3. Episode of re-transplantation [ Time Frame: 3 Years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Caregivers or parents of children undergoing liver transplantation Healthcare professionals caring for children undergoing liver transplantation

Inclusion Criteria:

Caregivers/parents of children with the following criteria will be approached for inclusion in this study:

  • Children <18 years of age at the time of transplant
  • Undergoing liver transplantation
  • Guardian's consent, child assent (in accordance with each institution's IRB policies)
  • Consents to enrollment in SPLIT

Exclusion Criteria:

Caregivers/parents of children undergoing liver transplantation will be excluded it:

  • Caregiver unwilling or unable to complete the survey
  • Child is a ward of the state (e.g., foster care) since present circumstances may not be reflective of child's past or future circumstances
  • Non-English, non-Spanish speakers
  • Non-US residents
  • Declined participation in SPLIT

Inclusion Criteria for Interview Portion of the Study:

  • Participants who have completed the questionnaire OR
  • Medical team member involved in the care of children undergoing liver transplant (e.g., physician, nurse, social worker)

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 identifier (NCT number): NCT04551742

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Contact: Emily Stekol 415-502-3190

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United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Carly Weaver    774-258-0286   
Principal Investigator: Shannon Zielsdorf, MD         
Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Noelle Ebel, MD    650-721-2250   
Principal Investigator: Noelle Ebel, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Emily Stekol    415-502-3190   
Principal Investigator: Sharad Wadhwani, MD, MPH         
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30329
Contact: Hillary Espinoza    404-785-1203   
Principal Investigator: Nitika Gupta, MD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Mary Riordan   
Principal Investigator: Saeed Mohammad, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Isaac Effiong    212-305-3839   
Principal Investigator: Jennifer Vittorio, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Kathleen Campbell, MD    513-636-4415   
Principal Investigator: Kathleen Campbell, MD         
United States, Pennsylvania
UPMC Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Alexandra Kepler, MPH    412-692-6692   
Principal Investigator: James Squires, MD, MS         
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Jatin Moghe   
Principal Investigator: Dev Desai, MD, PhD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Kara Cooper    206-987-4636   
Principal Investigator: Evelyn Hsu, MD         
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Sharad Wadhwani, MD, MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT04551742    
Other Study ID Numbers: 19-29632
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Health services research
Social determinants of health
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases