Impact of Telehealth Warfarin Education on Patient Retention

Medication Adherence Clinical Trial

Official title:

Impact of Telehealth Warfarin Education on Patient Retention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650777
• Other study ID #: 015-284
• Status: Completed
• Phase: N/A
• Start date: February 18, 2016
• Est. completion date: July 31, 2017

Study information

• Verified date: January 2019
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Educational Problems
• Medication Adherence

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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
Secondary	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)
Secondary	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)