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

Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04336735
• Other study ID #: 20-0527
• Secondary ID: K08HS026510
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: January 2022
• Source: University of Colorado, Denver
• Contact: Amy Feldman, MD
• Phone: 720-777-5354
• Email: amy.feldman[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Triads of parents, primary care physicians, and transplant sub-specialists will be enrolled to use a pre-transplant immunization tool while their child awaits transplant. The tool will provide information about vaccines, information about vaccine-preventable infections in the transplant population, a central easily accessible vaccine record, and a communication portal. The tool will also send vaccine reminders when vaccinations are due. The investigators will assess 1) the effectiveness of the tool in improving pre-transplant immunization rates, 2) the acceptability of the tool to users and 3) the feasibility of the tool.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Transplantation Infection
• Vaccination

Intervention

Other:
• immunization app
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

Locations

Country	Name	City	State
United States	Childrens Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptability and Feasibility of the Transplant Immunization Tool, as assessed by a questionnaire	We will assess whether the novel immunization tool is feasible and acceptable to users using a Likert scale with possible scores of 1-5, with 1 being least feasible/acceptable to the participant and 5 being the most feasible/acceptable.	Date of transplantation (up to 3 years post-enrollment)