Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool

NCT04336735 | Unknown

• 2 other identifiers: 20-0527K08HS026510
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Vaccine preventable infections are a serious complication following pediatric solid organ transplant. Immunizations are a minimally invasive and cost-effective was to reduce these infections. Despite the importance of pre-transplant vaccination, the majority of pediatric solid organ transplant recipients are not up-to-date on age-appropriate immunizations at the time of transplant. The goal of this study is to pilot a novel health information technology immunization tool to improve immunization rates in pediatric solid organ transplant candidates.

Conditions

Transplantation Infection; Vaccination

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Transplant Immunization Tool, as measured by number of patients with up-to-date vaccinations

  We will assess whether the novel immunization tool improves pre-transplant vaccination rates. The number of participants who are up to date with vaccinations will be reported.

  Date of transplantation (up to 3 years post-enrollment)

Secondary Outcomes (1)

• Acceptability and Feasibility of the Transplant Immunization Tool, as assessed by a questionnaire

  Date of transplantation (up to 3 years post-enrollment)

Study Arms (1)

Immunization Tool Users

EXPERIMENTAL

Users will trial a novel transplant-specific immunization tool (app)

Other: immunization app

Interventions

immunization app OTHER

A transplant specific immunization app will be trialed that 1) provides vaccine information and education, 2) stores vaccine records and 3) provides reminders when vaccines are due

Immunization Tool Users

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent, primary care provider and sub-specialist of a child awaiting heart, liver or kidney transplant

You may not qualify if:

• Non English speaking
• No access to a smart phone or computer

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Study Officials

• Amy Feldman

  UCD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Feldman, MD

CONTACT

720-777-5354; amy.feldman@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 45 triads of parents, primary care physicians and subspecialists of children awaiting heart, liver and kidney transplantation will be enrolled to use a novel immunization tool (app).

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: January 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)