Clinical trial NCT03910933: Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative
Official title: EKITE: Electronic KIDCLOT Interactive Thrombosis/Thrombophilia Education; A Quality Assurance Initiative
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Health Literacy
Anticoagulation
Keywords: Warfarin
Child
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 248
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English speaking children and their caregivers who initiate or require ongoing anticoaogulant therapy.

Brief summary: Effective patient education improves health literacy and engagement thus improving long-term health outcomes. Health literacy is imperative to make informed health decisions and relies on the ability to obtain, process and understand health information; and is the cornerstone of safe health management. It is necessary to evaluate educational initiatives to determine their effectiveness in knowledge translation.

A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patient teaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required.

Electronic KITE teaching modules are infographic visual representations that present information quickly and clearly, integrating words and graphics to tell a story to reveal information. Infographic presentations are tools which facilitate self-directed learning with understandable, accessible information presented in an engaging way with an aim to enhance learning for children and their families. Patients are able to learn at a pace consistent with their learning style to facilitate knowledge development and health literacy.

Detailed description: A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patienteaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required.

Electronic KITE teaching modules are infographic visual representations that have been developed to provide patient teaching related to warfarin and its management.

How much patients have learned will be assessed using the KIDCLOT validated knowledge quizzes. Children 8 years and older to have cognitive capacity will complete the quizzes if able. Caregivers will complete all quizzes linked with the modules they have completed.

Patients may be enrolled into the appropriate cohort based on the health provider decision for management.

1. Warfarin international normalized ratio (INR) testing
2. Warfarin with home INR testing
3. Warfarin transition from home INR testing to warfarin self management.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients and their caregivers who are receiving treatment with anticoagulant therapy.

Exclusion Criteria:

* Non-english speaking patients.

Primary outcomes:
measure: KIDCLOT What is an Anticoagulant Quiz1
timeFrame: enrolment
measure: KIDCLOT What is an Anticoagulant Quiz1
timeFrame: 6 months and 18 months
measure: Kidclot Warfarin Quiz 2
timeFrame: enrolment
measure: Kidclot Warfarin Quiz 2
timeFrame: 6 months and 18 months
measure: KIdclot INR testing Quiz 3
timeFrame: enrolment
measure: KIdclot INR testing Quiz 3
timeFrame: 6 and 18 months
measure: Kidclot safety on an anticoagulant Quiz 4
timeFrame: enrolment
measure: Kidclot safety on an anticoagulant Quiz 4
timeFrame: 6 months and 18 months
measure: Kidclot Home INR testing Quiz 5
timeFrame: enrolment
measure: Kidclot Home INR testing Quiz 5
timeFrame: 6 and 18 months
measure: Kidclot Warfarin Self Management Quiz 6
timeFrame: 6 months
measure: Kidclot Warfarin Self Management Quiz 6
timeFrame: 18 months
Secondary outcomes:
measure: Patient preference
timeFrame: enrolment
measure: Stress Around Learning Score STAI-1
timeFrame: enrolment
measure: Stress Around Learning Score STAI-1
timeFrame: enrolment
measure: Pediatric Anticoagulation Quality of Life
timeFrame: 6
measure: Pediatric Anticoagulation Quality of Life
timeFrame: 18 months
Other outcomes:
measure: Time in therapeutic Range
timeFrame: 18 months
measure: Health care provider time associated with warfarin teaching
timeFrame: enrolment, 6 months and 18 months
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Houston
country: United States
facility: Texas Children'Hospital
state: Texas
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Ottawa
country: Canada
facility: Children's Hospital of Easter Ontario
state: Ontario
Study officials:
affiliation: Stollery Children's Hospital, University of Alberta
name: Mary Bauman, MN
role: PRINCIPAL_INVESTIGATOR
References: