Learning Theory Patient Education for Anticoagulants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Patient Education for Anticoagulants Using Learning Theories - a Pilot Study

Conditions
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Knowledge, Attitudes, Practice

Intervention / Treatment
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* Behavioral: Anticoagulation Educational Materials
* Behavioral: Control Group: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>Standard Educational process | Behavioral: Control Group: Standard of Care<br>* This will be the current practice for patient education<br>|
| Experimental: Education Intervention<br>New educational intervention | Behavioral: Anticoagulation Educational Materials<br>* This includes new web-based patient educational materials that have been developed prior to the start of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | High acceptability based on self-reported questionnaires using Likert questions per the Theoretical Framework of Acceptability domains | 3 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulant, direct oral anticoagulant, vitamin k antagonist, warfarin, patient education, learning theory