Educational ProblemsNCT03650777
Impact of Telehealth Warfarin Education on Patient Retention
A study testing Warfarin Telehealth Education in people with Educational Problems and Medication Adherence, run by Baylor Research Institute.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Problems, Medication Adherence
- What is being tested?
- Warfarin Telehealth Education
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2016to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- English as a first language
- Currently taking warfarin for an approved indication
- Having the ability to see, read, and hear for verbal, written, and iPad® warfarin education
Who cannot join
- Age < 18 years
- Unwilling to receive iPad counseling
- Cognitive dysfunction and impairments that prevents patient from fully comprehending warfarin education
About this study
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
Read the detailed description
- 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.
- Study Design
- This study is a prospective, single-centered, randomized controlled quality improvement pilot study.
- Warfarin Education Procedures
- Each Friday morning, the pharmacist will identify the patients with appointments for INR checks.
- As each patient checks in for their appointment, the pharmacist will ask the patient for consent to be a part of the study
- 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
- Intervention patients (iPAD® video)
- The patient will then watch a warfarin education video on the iPAD®
- After the video the patient will receive point of care INR check and have their warfarin dose adjusted
- Patient will then complete the same warfarin questionnaire
- After completion, answers to the questionnaire will be presented to the patient. A written brochure will be given.
- A satisfaction survey will be given
- 30-60 days days later the pharmacist will follow up with the patient to repeat the warfarin questionnaire
- Description of iPAD video
- 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.
- Control group
- Patients' INR will be taken and warfarin education will be given verbally similar to Monday-Thursday clinic. A written brochure will be given.
- Conditions
- Educational Problems, Medication Adherence
- Being tested
- Warfarin Telehealth Education
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin Telehealth EducationOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: initial and follow up visit (max 30 days)
Secondary outcomes (4)
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
Measured: 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.
Measured: Max 30 days
Adverse Events
Descriptive results of patient self reported adverse events related to warfarin between initial and follow up visit
Measured: 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
Measured: Between initial and follow up visit ( max 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start18 Feb 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Educational Intervention
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650777
- Sponsor's protocol ID
- 015-284
- Status last verified
- Jan 2019
- First submitted
- 6 Aug 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31382942
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telehealth Warfarin Education on Patient Retention
- ClinicalTrials.gov ID
- NCT03650777
- Acronym / sponsor ID
- 015-284
- Conditions
- Educational Problems, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 18 Feb 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Study Design
- This study is a prospective, single-centered, randomized controlled quality improvement pilot study.
- Warfarin Education Procedures
- Each Friday morning, the pharmacist will identify the patients with appointments for INR checks.
- As each patient checks in for their appointment, the pharmacist will ask the patient for consent to be a part of the study
- 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
- Intervention patients (iPAD® video)
- The patient will then watch a warfarin education video on the iPAD®
- After the video the patient will receive point of care INR check and have their warfarin dose adjusted
- Patient will then complete the same warfarin questionnaire
- After completion, answers to the questionnaire will be presented to the patient. A written brochure will be given.
- A satisfaction survey will be given
- 30-60 days days later the pharmacist will follow up with the patient to repeat the warfarin questionnaire
- Description of iPAD video
- 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.
- Control group
- Patients' INR will be taken and warfarin education will be given verbally similar to Monday-Thursday clinic. A written brochure will be given.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Educational Intervention
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- English as a first language
- Currently taking warfarin for an approved indication
- Having the ability to see, read, and hear for verbal, written, and iPad® warfarin education
Key exclusion criteria (3 listed)
- Age < 18 years
- Unwilling to receive iPad counseling
- Cognitive dysfunction and impairments that prevents patient from fully comprehending warfarin education
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin Telehealth EducationPatients received education on warfarin through a video on an iPad, and were assessed on knowledge pre and post video, and at follow up visit | Other | – |
Primary outcome
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
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
4 secondary outcomes
Self Reported Adherence to Warfarin therapy during duration of study
Time frame: Between initial and follow up visit ( max 30 days)
Satisfaction Survey
Time frame: Max 30 days
Adverse Events
Time frame: Between initial and follow up visit ( max 30 days)
Time of Warfarin in Therapeutic Range for Duration of Study
Time frame: Between initial and follow up visit ( max 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 31382942Heinrich 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin Telehealth Education in people with Educational Problems and Medication Adherence, run by Baylor Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Retention of Warfarin Education post video watching (time frame: pre and post video test(20 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.