AnticoagulationNCT03575936
Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic
A study testing Home INR Monitoring in people with Anticoagulation and Home INR Monitoring, run by University of South Florida.
Trial summary
Introduction: The ambulatory care pharmacist service is a vision that is supported by several national pharmacy associations and expected by many clinical environments. However, pharmacists practicing in such settings often lack the data to demonstrate their value for the services they provide. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anticoagulation, Home INR Monitoring
- What is being tested?
- Home INR Monitoring
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Dec 2018
- 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
- Established patients within the USF Morsani Center Family Medicine department
- Adults over the age of 18 years
- Long-term (> 12 months) warfarin therapy
- Taking warfarin for at least 90 days prior to enrollment
- Willing and able to perform home INR monitoring with correct technique (or caregiver)
Who cannot join
- Failure by either the patient or caregiver to demonstrate successful INR monitoring technique
- Issues with mental and/or physical dexterity as evaluated and determined by the pharmacist
- Unwillingness to take full financial responsibility for costs not covered (by patient's insurance and/or grant money) incurred with home INR monitoring
About this study
Introduction:
The ambulatory care pharmacist service is a vision that is supported by several national pharmacy associations and expected by many clinical environments. However, pharmacists practicing in such settings often lack the data to demonstrate their value for the services they provide. Consequently, clinical services provided by pharmacists are not viewed as a billable expense and reimbursements are bundled with drug dispensing. Thus, if a pharmacy service is to sustain for the long-term, it is imperative to develop a value model to support monetary compensation for the cognitive services provided.
Read more
Background and Significance:
Anticoagulation with warfarin is a high risk therapy involving complex dosing, monitoring, and ensuring adherence to outpatient therapy. Monitoring anticoagulation intensity utilizing the prothrombin time (PT) and the international normalized ratio (INR) is used to determine the effectiveness of anticoagulation therapy. The proportion of time the INR is within the therapeutic range (TTR) is considered a surrogate measure of anticoagulation control and is associated with lower rates of major bleeds and thromboembolism.
Pharmacist managed anticoagulation clinics eliminate the waiting period between lab work from an external facility and decisions from physicians. Pharmacists practicing in anticoagulation clinics with point-of-care INR testing usually practice under a collaborative agreement, which allows them to adjust and reverse warfarin dosing based on established protocols. This reduces the wait time and is expected to increase patient satisfaction. Despite the wide acceptance of pharmacist-managed anticoagulation clinics, there is inconsistent evidence to support prevention of major bleeding.
Methods:
This is an IRB-approved prospective, unblinded randomized controlled trial of the clinical impact of home anticoagulation monitoring. The study will enroll all patients (who meet eligibility criteria) who require long-term anticoagulation therapy from a pharmacist-managed anticoagulation clinic.
Expected Outcomes:
The purpose of this study is to evaluate if self- monitoring in addition to pharmacist review will increase the TTR. This will allow university- based pharmacists to provide care for more patients effectively in addition to their academic duties.
- Conditions
- Anticoagulation, Home INR Monitoring
- Being tested
- Home INR Monitoring, Standard of Care
- Keywords
- Pharmacists Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home INR MonitoringDevice
Also called Alere Home INR Machine
The self-monitoring group will monitor INR at home using the AlereTM Home Monitoring Service. They will call in the weekly results to Alere or submit online via the patient portal, which is the standard protocol among home monitoring patients. Alere will then upload the information to a password-protected HIPAA compliant website that only study investigators will be able to access. Pharmacists will have real-time access to the test results via the web interface. Pharmacists can follow up in real time if the patient forgets to self-test. An alert will also be sent to the pharmacists via email to follow up on any out of range results. This will help streamline pharmacists' workload to dedicate face-to-face time for patients that require such intervention. All home monitoring patients will be seen in clinic by the pharmacist at the end of the 3-month randomization period in order to assess compliance with meter-use and re-evaluate meter-use competency.
Standard of CareProcedure or surgery
The patients in the standard of care group will have a clinic visit with the pharmacist at least once every 4 weeks or earlier, as deemed necessary by the pharmacist. The duration of the randomization period will be three months. At the end of the 3-month randomization period, patients will be provided the opportunity to cross over from the home INR monitoring group to the pharmacist-managed clinic group, or vice versa. The remainder of the study duration (post-3 month analysis) will purely be for observational purposes, in order to account for the loss of randomization and potential bias. The total duration of the study will be one year.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Active comparator | Standard of Care arm. Pharmacist intervention in clinic Receives: Procedure: Standard of Care |
| Home Monitoring Group | Experimental | Pharmacist intervention with home INR monitoring Receives: Device: Home INR Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
INR
INR obtained weekly via home monitoring arm. INR obtained every 4 weeks or sooner for patients seen in clinic. Two arms compared to determine time within therapeutic range.
Measured: 12 months
Secondary outcomes (1)
Patient Satisfaction and Quality of Life with Anticoagulation utilizing the Duke Anticoagulation Satisfaction Scale (DASS)
Patients were given the DASS survey at baseline, 3 mo (end of randomization) \& end of study (12 mo), in order to assess satisfaction with warfarin therapy \& management. The DASS is a validated survey, including 25 items, each containing 7 response categories: "not at all, a little, somewhat, moderately, quite a bit, a lot, \& very much". Questions are arranged to correspond to 3 possible dimensions pertaining to anticoagulation: limitations, hassles \& burdens, \& positive psychological impacts. The DASS is able to summarize satisfaction with anticoagulation \& identify aspects that may hinder individual patients from maintaining an INR within therapeutic range. Many interventions can potentially be designed to improve anticoagulation quality of care, \& thus reduce the time spent outside of therapeutic range, \& ultimately thromboembolic \& bleeding events by identifying the limitations, hassles \& burdens, as well as positive psychological impacts experienced by patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study startOct 2016
- Primary completionJun 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575936
- Sponsor's protocol ID
- Anticoagulation
- Status last verified
- May 2018
- First submitted
- 23 May 2018
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic
- ClinicalTrials.gov ID
- NCT03575936
- Acronym / sponsor ID
- Anticoagulation
- Conditions
- Anticoagulation, Home INR Monitoring
- Keywords
- Pharmacists Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Jul 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.
Introduction:
The ambulatory care pharmacist service is a vision that is supported by several national pharmacy associations and expected by many clinical environments. However, pharmacists practicing in such settings often lack the data to demonstrate their value for the services they provide. Consequently, clinical services provided by pharmacists are not viewed as a billable expense and reimbursements are bundled with drug dispensing. Thus, if a pharmacy service is to sustain for the long-term, it is imperative to develop a value model to support monetary compensation for the cognitive services provided.
Background and Significance:
Anticoagulation with warfarin is a high risk therapy involving complex dosing, monitoring, and ensuring adherence to outpatient therapy. Monitoring anticoagulation intensity utilizing the prothrombin time (PT) and the international normalized ratio (INR) is used to determine the effectiveness of anticoagulation therapy. The proportion of time the INR is within the therapeutic range (TTR) is considered a surrogate measure of anticoagulation control and is associated with lower rates of major bleeds and thromboembolism.
Pharmacist managed anticoagulation clinics eliminate the waiting period between lab work from an external facility and decisions from physicians. Pharmacists practicing in anticoagulation clinics with point-of-care INR testing usually practice under a collaborative agreement, which allows them to adjust and reverse warfarin dosing based on established protocols. This reduces the wait time and is expected to increase patient satisfaction. Despite the wide acceptance of pharmacist-managed anticoagulation clinics, there is inconsistent evidence to support prevention of major bleeding.
Methods:
This is an IRB-approved prospective, unblinded randomized controlled trial of the clinical impact of home anticoagulation monitoring. The study will enroll all patients (who meet eligibility criteria) who require long-term anticoagulation therapy from a pharmacist-managed anticoagulation clinic.
Expected Outcomes:
The purpose of this study is to evaluate if self- monitoring in addition to pharmacist review will increase the TTR. This will allow university- based pharmacists to provide care for more patients effectively in addition to their academic duties.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | Active comparator | Procedure: Standard of CareStandard of Care arm. Pharmacist intervention in clinic |
| Home Monitoring Group | Experimental | Device: Home INR MonitoringPharmacist intervention with home INR monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Established patients within the USF Morsani Center Family Medicine department
- Adults over the age of 18 years
- Long-term (> 12 months) warfarin therapy
- Taking warfarin for at least 90 days prior to enrollment
- Willing and able to perform home INR monitoring with correct technique (or caregiver)
Key exclusion criteria (3 listed)
- Failure by either the patient or caregiver to demonstrate successful INR monitoring technique
- Issues with mental and/or physical dexterity as evaluated and determined by the pharmacist
- Unwillingness to take full financial responsibility for costs not covered (by patient's insurance and/or grant money) incurred with home INR monitoring
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 |
|---|---|---|
| Home INR MonitoringAlso: Alere Home INR MachineThe self-monitoring group will monitor INR at home using the AlereTM Home Monitoring Service. They will call in the weekly results to Alere or submit online via the patient portal, which is the standard protocol among home monitoring patients. Alere will then upload the information to a password-protected HIPAA compliant website that only study investigators will be able to access. Pharmacists will have real-time access to the test results via the web interface. Pharmacists can follow up in real time if the patient forgets to self-test. An alert will also be sent to the pharmacists via email to follow up on any out of range results. This will help streamline pharmacists' workload to dedicate face-to-face time for patients that require such intervention. All home monitoring patients will be seen in clinic by the pharmacist at the end of the 3-month randomization period in order to assess compliance with meter-use and re-evaluate meter-use competency. | Device | Home Monitoring Group |
| Standard of CareThe patients in the standard of care group will have a clinic visit with the pharmacist at least once every 4 weeks or earlier, as deemed necessary by the pharmacist. The duration of the randomization period will be three months. At the end of the 3-month randomization period, patients will be provided the opportunity to cross over from the home INR monitoring group to the pharmacist-managed clinic group, or vice versa. The remainder of the study duration (post-3 month analysis) will purely be for observational purposes, in order to account for the loss of randomization and potential bias. The total duration of the study will be one year. | Procedure or surgery | Standard of Care Group |
Primary outcome
INR
Time frame: 12 months
INR obtained weekly via home monitoring arm. INR obtained every 4 weeks or sooner for patients seen in clinic. Two arms compared to determine time within therapeutic range.
1 secondary outcome
Patient Satisfaction and Quality of Life with Anticoagulation utilizing the Duke Anticoagulation Satisfaction Scale (DASS)
Time frame: 12 months
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 11 Nov 2021.
- Individual participant dataSharing planned: No
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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 Home INR Monitoring in people with Anticoagulation and Home INR Monitoring, run by University of South Florida.
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 5 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 11 Nov 2021. 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?
INR (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2021.