Clinical trial NCT05750498: A-LiNK: Improving Outcomes in Autoimmune Liver Disease
Official title: Autoimmune Liver Disease Network for Kids (A-LiNK): Using Patient Data to Transform Care and Improve Outcomes for Children, Adolescents, and Young Adults with Autoimmune Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Hepatitis
Primary Sclerosing Cholangitis
Keywords: Pediatrics
Autoimmune Hepatitis
Primary Sclerosing Cholangitis
Autoimmune Sclerosing Cholangitis
Chronic Liver Disease
End-stage Liver Disease
Clinical Registry
Research Registry
Quality Improvement
Outcomes Research
Comparative Effectiveness Research
Patient Reported Outcomes
Health Services Research
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a clinical diagnosis of Autoimmune Hepatitis (AIH), Primary Sclerosing Cholangitis (PSC), and Autoimmune Sclerosing Cholangitis (ASC).

Patient recruitment will be conducted by the care centers participating in the registry.

This also includes the recruitment of Spanish and other language-speaking patients.

Participants who are enrolled in ImproveCareNow and who are eligible for A-LiNK will be separately consented to this study.

Brief summary: The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD).

This study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative.

Pediatric Autoimmune Hepatitis (AIH) and Primary Sclerosing Cholangitis (PSC), represent a spectrum of AILD which present unique diagnostic and therapeutic challenges.A lack of accepted guidelines for disease monitoring or symptom management results in wide treatment variation with liver transplants indicated in refractory, progressive disease.

The aims of A-LiNK are to:

1.) Create a learning health network focused on patient-centered outcomes research characterized by transparent sharing among centers, common priorities, and feasible plans for implementing new practices; 2) shift from traditional investigator-driven study to a patient and family-centered approach, and 3.) improve clinical outcomes and quality of life for pediatric AILD patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of autoimmune hepatitis (AIH)
* Clinical diagnosis of primary sclerosing cholangitis (PSC)
* Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)

Exclusion Criteria:

• History of liver transplant

Primary outcomes:
measure: Baseline disease characteristics in the population
timeFrame: 2034
measure: Disease relapse and biochemical remission rates
timeFrame: 2034
measure: Complications of disease
timeFrame: 2034
measure: Side-effects of steroids
timeFrame: 2034
measure: Pediatric Quality of Life Inventory (PedsQL 4.0) Generic Core Scales Short Form 15
timeFrame: 2034
measure: Racial and ethnic disparities
timeFrame: 2034
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Indianapolis
country: United States
facility: Riley Children's Health
state: Indiana
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Amy E Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References: