AnticoagulationACTIVENCT04059965
AntiCoagulation Tracking InterVention and Evaluation
A study testing Panel Management for Anticoagulation Therapy in people with Anticoagulation and Atrial Fibrillation, run by University of California, San Francisco.
Trial summary
Anticoagulants are a leading cause of acute injury from adverse drug events, leading to ~20,000 serious injuries reported to the Food and Drug Administration per year and more than 220,000 emergency department visits annually. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anticoagulation, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Panel Management for Anticoagulation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Sep 2025
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (age ≥18 years)
- those prescribed an anticoagulation medication at Zuckerberg San Francisco General Hospital or University of California, San Francisco Health
Who cannot join
- Minors (age<18)
- those not prescribed anticoagulation medication at ZSFG or UCSF Health
About this study
Official title: AntiCoagulation Tracking InterVention and Evaluation: Using a Customized Panel Management Platform to Improve Outcomes for Patients on Anticoagulation
Anticoagulants are a leading cause of acute injury from adverse drug events, leading to ~20,000 serious injuries reported to the Food and Drug Administration per year and more than 220,000 emergency department visits annually. Therefore, we propose to implement a health information technology (HIT) population management tool at two distinct anticoagulation clinics that will allow the care team to assign and track tasks essential for timely patient monitoring. We will examine its effect on anticoagulation management outcomes through a randomized trial, hypothesizing that such interventions can be effective as well as cost-effective strategies to improve patient safety in the context of anticoagulation management services.
- Conditions
- Anticoagulation, Atrial Fibrillation, Atrial Flutter, Pulmonary Embolus/Emboli, Deep Vein Thrombosis, Stroke
- Being tested
- Panel Management for Anticoagulation Therapy, Usual Care
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Pulmonary Embolism, Embolism, Venous Thrombosis, Stroke, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panel Management for Anticoagulation TherapyOther
Patients in the intervention arm will receive notifications reminding them of upcoming labs and appointments. We hypothesize this will improve adherence and therapeutic control and reduce risk for bleeds and/or strokes
Usual CareOther
Patients will receive standard, protocolized care in their respective anticoagulation clinics
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | This cohort of patients will receive panel management through a customize software that integrates with the electronic health record Receives: Other: Panel Management for Anticoagulation Therapy |
| Control Arm | Active comparator | This cohort of patients will receive usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Therapeutic Range
Using the Rosendaal method, we will assess the proportion of the treatment duration that the patient's International Normalized Ratio is within the goal therapeutic range.
Measured: 6 months
Secondary outcomes (3)
Proportion Time in Range
Simple ratio of proportion of time patient's International Normalized Ratio is in goal range.
Measured: 6 months
Time from initiation to therapeutic INR (TWTR)
Time to achieve first therapeutic international normalized ratio
Measured: Study Period (average of 2 years)
Adverse events
Incidence of bleeds, deep vein thrombosis, pulmonary embolism, and stroke)
Measured: Study Period (average of 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Oct 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Why it stopped: Lack of funding
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 California, San FranciscoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urmimala Sarkar, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059965
- Sponsor's protocol ID
- P0534218
- Acronym
- ACTIVE
- Status last verified
- Aug 2022
- First submitted
- 27 May 2019
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AntiCoagulation Tracking InterVention and Evaluation: Using a Customized Panel Management Platform to Improve Outcomes for Patients on Anticoagulation
- ClinicalTrials.gov ID
- NCT04059965
- Acronym / sponsor ID
- ACTIVE / P0534218
- Conditions
- Anticoagulation, Atrial Fibrillation, Atrial Flutter, Pulmonary Embolus/Emboli, Deep Vein Thrombosis, Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 16 Aug 2019 (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.
Anticoagulants are a leading cause of acute injury from adverse drug events, leading to ~20,000 serious injuries reported to the Food and Drug Administration per year and more than 220,000 emergency department visits annually. Therefore, we propose to implement a health information technology (HIT) population management tool at two distinct anticoagulation clinics that will allow the care team to assign and track tasks essential for timely patient monitoring. We will examine its effect on anticoagulation management outcomes through a randomized trial, hypothesizing that such interventions can be effective as well as cost-effective strategies to improve patient safety in the context of anticoagulation management services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Panel Management for Anticoagulation TherapyThis cohort of patients will receive panel management through a customize software that integrates with the electronic health record |
| Control Arm | Active comparator | Other: Usual CareThis cohort of patients will receive usual care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (age ≥18 years)
- those prescribed an anticoagulation medication at Zuckerberg San Francisco General Hospital or University of California, San Francisco Health
Key exclusion criteria (2 listed)
- Minors (age<18)
- those not prescribed anticoagulation medication at ZSFG or UCSF Health
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 |
|---|---|---|
| Panel Management for Anticoagulation TherapyPatients in the intervention arm will receive notifications reminding them of upcoming labs and appointments. We hypothesize this will improve adherence and therapeutic control and reduce risk for bleeds and/or strokes | Other | Intervention Arm |
| Usual CarePatients will receive standard, protocolized care in their respective anticoagulation clinics | Other | Control Arm |
Primary outcome
Time in Therapeutic Range
Time frame: 6 months
Using the Rosendaal method, we will assess the proportion of the treatment duration that the patient's International Normalized Ratio is within the goal therapeutic range.
3 secondary outcomes
Proportion Time in Range
Time frame: 6 months
Time from initiation to therapeutic INR (TWTR)
Time frame: Study Period (average of 2 years)
Adverse events
Time frame: Study Period (average of 2 years)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- 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.
Urmimala Sarkar, MD, MPH principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Panel Management for Anticoagulation Therapy in people with Anticoagulation and Atrial Fibrillation, run by University of California, San Francisco.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 4 Aug 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time in Therapeutic Range (time frame: 6 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 4 Aug 2022.