Learning Theory Patient Education for Anticoagulants

Knowledge, Attitudes, Practice Clinical Trial

Official title:

Patient Education for Anticoagulants Using Learning Theories - a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06138184
• Other study ID #: IRB_00146488
• Secondary ID: 1K23HL157751-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: University of Utah
• Contact: Aubrey E Jones, PharmD, MSCI
• Phone: 801-587-9715
• Email: aubrey.e.jones[@]pharm.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to test the feasibility of a randomized control trial evaluating the educational tool for anticoagulated patients. Participants will be randomized to use new educational materials or current existing educational materials and answer survey questions.

Description:

Eligible patients will be randomized using stratified block randomization to control for the type of anticoagulant (warfarin vs. DOAC) and status (naïve vs. experienced) to either the education intervention from Aim 2 or standard of care Data will be collected via online surveys before the intervention, immediately after, and then 3 months after the intervention. Patients at the University of Utah Thrombosis Clinic will be recruited.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• initiating (naïve) or currently taking (experienced) oral anticoagulants with an anticipated treatment duration of at least three months
• Experienced patients will be eligible if they score less than 75% on the Anticoagulation Knowledge Test

Exclusion Criteria:

• Deficits in cognitive abilities, sensory input, or language significant enough to impede their use of the education tool and/or provision of written informed consent

Related Conditions & MeSH terms

• Knowledge, Attitudes, Practice

Intervention

Behavioral:
• Anticoagulation Educational Materials
This includes new web-based patient educational materials that have been developed prior to the start of the study
• Control Group: Standard of Care
This will be the current practice for patient education

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient knowledge	Anticoagulation Knowledge Test 28 item scale for patients taking warfarin or a direct oral anticoagulant to assess their knowledge , Minimum score = 0, Max score = 28. Higher scores indicate more knowledge	3 months
Other	Information overload	adapted Cancer Information Overload Scale 5-item scale from Strongly Disagree to Strongly Agree. Minimum score = 5, maximum score = 20. The higher the score indicates higher information overload.	3 months
Other	Adherence	Visual Analog Rating Scale (VAS) asks patients to estimate in a specified time period (the 3 months of the study period), the percentage of medication doses that they have taken as prescribed (0-100%) Higher percentage means higher adherence.	3 months
Other	Clinical outcomes	Patients will report the number (if any) of thromboembolic (stroke, deep vein thrombosis, pulmonary or systemic embolism), or bleeding events that they have had during the study period. We will also review patient charts to see if there are any reported events in the chart that are not reported by the patient. Bleeding events will be classified into major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) definitions. We will also monitor for any deaths that may occur.	3 months
Primary	Feasibility of implementing a randomized control trial	The study will be feasible if 1) the consent rate if 5 patients per month, 2) Proportion of patients completing the educational tool is 90%; 3) Loss to follow-up at three months is 20% or less	18 months
Secondary	Acceptability	High acceptability based on self-reported questionnaires using Likert questions per the Theoretical Framework of Acceptability domains	3 months
Secondary	Acceptability - Educational Tool	This will be measured using an adapted version of the Ottawa Decision Aid Acceptability Measures which is a 10-question tool shortened to 5 questions that assess: 1) The way information is presented, 2) Length of the Materials, 3) Amount of information, 4) What was liked, and 5) Suggestions for improvement	At time of intervention
Secondary	Acceptability - Workflow Disruption	2 questions to providers asking to rate how much a) the study disrupted their workflow and b) how much the educational tool disrupted their workflow on a scale from 1- Very disruptive to 5 - Not all disruptive. Higher scores are better outcomes	18 months
Secondary	Acceptability - Satisfaction	Patients and providers will both complete a 5 point Likert scale asking how satisfied they are with the educational materials, with 1 being Very dissatisfied and 5 being Very Satisfied.	3 months
Secondary	Acceptability - Intervention/Survey Fatigue	1 question measuring survey fatigue: 1) the length of surveys was a) too long, b) too short, c) just right and the number of surveys that were not filled out/not completed. If the majority of surveys are not completed or started, and the majority of patients answer that the length of surveys was too long, that will indicate high survey fatigue	3 months