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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT04336735

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transplantation Infection Vaccination	Other: immunization app	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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).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).

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immunization Tool Users Users will trial a novel transplant-specific immunization tool (app)	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

Arm

Intervention/Treatment

Experimental: Immunization Tool Users

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

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

Outcome Measures

Primary Outcome Measures

Effectiveness of Transplant Immunization Tool, as measured by number of patients with up-to-date vaccinations [Date of transplantation (up to 3 years post-enrollment)]
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.

Secondary Outcome Measures

Acceptability and Feasibility of the Transplant Immunization Tool, as assessed by a questionnaire [Date of transplantation (up to 3 years post-enrollment)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens Hospital Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

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

Investigators

Principal Investigator: Amy Feldman, UCD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT04336735

Other Study ID Numbers:

20-0527
K08HS026510

First Posted:

Apr 7, 2020

Last Update Posted:

Jan 12, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 12, 2022