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Impact of Telehealth Warfarin Education on Patient Retention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03650777
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
The objective of this study is to evaluate the effectiveness of telehealth warfarin education in a charity outpatient clinic. The purpose is to increase patient knowledge with regard to their warfarin therapy and to measure knowledge retention

Condition or disease Intervention/treatment Phase
Educational Problems Medication Adherence Other: Warfarin Telehealth Education Not Applicable

Detailed Description:

2. This study is conducted in outpatient ambulatory care clinics at the Baylor Family Medicine Worth Street clinic and the Irving Interfaith clinic. The average census for warfarin patients Friday clinic is 10. The anticoagulation clinic consists of an interdisciplinary team including physicians, medical assistants, nurse practitioners, and pharmacists. Patients initially visit with the provider and subsequent follow up INR checks are performed by the pharmacists or medical assistants. Currently, pharmacists manage the anticoagulation clinic on Fridays and medical assistants manage the clinic on Monday through Thursday. All providers provide patient education through written brochures.

3. Study Design

a. This study is a prospective, single-centered, randomized controlled quality improvement pilot study.

4. Warfarin Education Procedures

  1. Each Friday morning, the pharmacist will identify the patients with appointments for INR checks.
  2. As each patient checks in for their appointment, the pharmacist will ask the patient for consent to be a part of the study
  3. If the patient says yes, the pharmacist will have the patient complete a warfarin questionnaire and health literacy test to see the patient's baseline knowledge on their warfarin therapy
  4. Intervention patients (iPAD® video)

    1. The patient will then watch a warfarin education video on the iPAD®
    2. After the video the patient will receive point of care INR check and have their warfarin dose adjusted
    3. Patient will then complete the same warfarin questionnaire
    4. After completion, answers to the questionnaire will be presented to the patient. A written brochure will be given.
    5. A satisfaction survey will be given
    6. 30-60 days days later the pharmacist will follow up with the patient to repeat the warfarin questionnaire

    5. Description of iPAD video

a. Setting: a pharmacy b. Description: A pharmacist will provide education about warfarin using not only verbal instructions but also provide illustrations of directions. Please refer to Appendix for dialogue.

6. Control group

a. Patients' INR will be taken and warfarin education will be given verbally similar to Monday-Thursday clinic. A written brochure will be given.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Educational Intervention
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Telehealth Warfarin Education on Patient Retention
Actual Study Start Date : February 18, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Intervention Details:
  • Other: Warfarin Telehealth Education
    Patients received education on warfarin through a video on an iPad, and were assessed on knowledge pre and post video, and at follow up visit

Primary Outcome Measures :
  1. Knowledge Retention of Warfarin Education post video watching [ Time Frame: pre and post video test(20 minutes) ]
    Difference in pre warfarin education video and post video test for warfarin education in patients receiving warfarin education via iPad

  2. Long Term Knowledge Retention of warfarin education post video watching [ Time Frame: initial and follow up visit (max 30 days) ]
    Difference in pre video test and follow up retention test for warfarin education in patients receiving warfarin education via iPad

Secondary Outcome Measures :
  1. Self Reported Adherence to Warfarin therapy during duration of study [ Time Frame: Between initial and follow up visit ( max 30 days) ]
    Descriptive results of patient self reported adherence (yes/no response) related to warfarin between initial and follow up visit

  2. Satisfaction Survey [ Time Frame: Max 30 days ]
    A satisfaction survey (designed by pharmacy resident) with 4 questions based on Likert scale (0-5), and one free response question patient completes on follow up visit. Name of Scale used for 4 questions: Likert. (Range 1-5, 1= highly disagree, 2= disagree, 3-neutral, 4-agree, 5-highly agree). There was no total of scoring, each response was individual of each other.

  3. Adverse Events [ Time Frame: Between initial and follow up visit ( max 30 days) ]
    Descriptive results of patient self reported adverse events related to warfarin between initial and follow up visit

  4. Time of Warfarin in Therapeutic Range for Duration of Study [ Time Frame: Between initial and follow up visit ( max 30 days) ]
    Time patient was within therapeutic range for their INR goal between initial and follow up visit

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age > 18 years
  2. English as a first language
  3. Currently taking warfarin for an approved indication
  4. Having the ability to see, read, and hear for verbal, written, and iPad® warfarin education

Exclusion Criteria:

  1. Age < 18 years
  2. Unwilling to receive iPad counseling
  3. Cognitive dysfunction and impairments that prevents patient from fully comprehending warfarin education

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Baylor Research Institute Identifier: NCT03650777     History of Changes
Other Study ID Numbers: 015-284
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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