About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Anticoagulation Educational Materials
BehavioralThis includes new web-based patient educational materials that have been developed prior to the start of the study
Control Group: Standard of Care
BehavioralThis will be the current practice for patient education
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Acceptability
High acceptability based on self-reported questionnaires using Likert questions per the Theoretical Framework of Acceptability domains
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
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
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.
Other outcomes
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
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.
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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: