Learning Theory Patient Education for Anticoagulants

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06138184

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Knowledge, Attitudes, Practice	Behavioral: Anticoagulation Educational Materials Behavioral: Control Group: Standard of Care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Patient Education for Anticoagulants Using Learning Theories - a Pilot Study

Anticipated Study Start Date :

Jun 1, 2024

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Standard Care

Standard Educational process

Behavioral: Control Group: Standard of Care

This will be the current practice for patient education

Experimental: Education Intervention

New educational intervention

Behavioral: Anticoagulation Educational Materials

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

Outcome Measures

Primary Outcome Measures

Feasibility of implementing a randomized control trial [18 months]
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 Outcome Measures

Acceptability [3 months]
High acceptability based on self-reported questionnaires using Likert questions per the Theoretical Framework of Acceptability domains
Acceptability - Educational Tool [At time of intervention]
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 [18 months]
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 [3 months]
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.
Acceptability - Intervention/Survey Fatigue [3 months]
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

Other Outcome Measures

Patient knowledge [3 months]
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 [3 months]
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 [3 months]
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 [3 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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