Impact of Telehealth Warfarin Education on Patient Retention

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

Study Overview

• Status: Completed
• Conditions: Medication Adherence; Educational Problems
• Intervention / Treatment: Other: Warfarin Telehealth Education

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge Retention of Warfarin Education post video watching	Difference in pre warfarin education video and post video test for warfarin education in patients receiving warfarin education via iPad	pre and post video test(20 minutes)
Long Term Knowledge Retention of warfarin education post video watching	Difference in pre video test and follow up retention test for warfarin education in patients receiving warfarin education via iPad	initial and follow up visit (max 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Reported Adherence to Warfarin therapy during duration of study	Descriptive results of patient self reported adherence (yes/no response) related to warfarin between initial and follow up visit	Between initial and follow up visit ( max 30 days)
Satisfaction Survey	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.	Max 30 days
Adverse Events	Descriptive results of patient self reported adverse events related to warfarin between initial and follow up visit	Between initial and follow up visit ( max 30 days)
Time of Warfarin in Therapeutic Range for Duration of Study	Time patient was within therapeutic range for their INR goal between initial and follow up visit	Between initial and follow up visit ( max 30 days)

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Publications and helpful links

General Publications

• Heinrich K, Sanchez K, Hui C, Talabi K, Perry M, Qin H, Nguyen H, Tatachar A. Impact of an electronic medium delivery of warfarin education in a low income, minority outpatient population: a pilot intervention study. BMC Public Health. 2019 Aug 5;19(1):1050. doi: 10.1186/s12889-019-7370-4.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2016
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: August 6, 2018
• First Submitted That Met QC Criteria: August 26, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anticoagulants; Warfarin
• Other Study ID Numbers: 015-284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No