Learning Theory Patient Education for Anticoagulants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Anticoagulation Educational Materials

    Behavioral

    This includes new web-based patient educational materials that have been developed prior to the start of the study

  • Control Group: Standard of Care

    Behavioral

    This will be the current practice for patient education

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Standard CareActive comparator 1 intervention
Group B: Education InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
18 months

Secondary outcomes

1

Acceptability

High acceptability based on self-reported questionnaires using Likert questions per the Theoretical Framework of Acceptability domains

Time frame
3 months
2

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

Time frame
At time of intervention
3

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

Time frame
18 months
4

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.

Time frame
3 months

Other outcomes

1

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

Time frame
3 months
2

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.

Time frame
3 months
3

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.

Time frame
3 months
4

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.

Time frame
3 months

Locations

This trial has no 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: