Clinical trial NCT03650777: Impact of Telehealth Warfarin Education on Patient Retention
Official title: Impact of Telehealth Warfarin Education on Patient Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Medication Adherence
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Educational Intervention
Primary purpose: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge Retention of Warfarin Education post video watching
timeFrame: pre and post video test(20 minutes)
measure: Long Term Knowledge Retention of warfarin education post video watching
timeFrame: initial and follow up visit (max 30 days)
Secondary outcomes:
measure: Self Reported Adherence to Warfarin therapy during duration of study
timeFrame: Between initial and follow up visit ( max 30 days)
measure: Satisfaction Survey
timeFrame: Max 30 days
measure: Adverse Events
timeFrame: Between initial and follow up visit ( max 30 days)
measure: Time of Warfarin in Therapeutic Range for Duration of Study
timeFrame: Between initial and follow up visit ( max 30 days)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.