Cardiovascular DiseasesNCT04068727
LEAVE Safe With DOACs
A study testing Clinical Pharmacist Intervention in people with Cardiovascular Diseases and Venous Thromboembolism, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Given the risks associated with direct oral anticoagulants (DOACs) and the lack of defined pathways for patients prescribed this class of medications, the study intervention has the potential for an enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Venous Thromboembolism, Atrial Fibrillation
- What is being tested?
- Clinical Pharmacist Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 14 Sep 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- New prescription of DOAC within 4 days of consent OR continued DOAC use for a patient with new episode of worsening thromboembolic or bleeding event within 4 days of consent or discharged from the hospital with DOAC prescription within 4 days of consent
- Fluency in English, Portuguese, or Spanish
Who cannot join
- Currently hospitalized with inpatient status (as opposed to observation status)
- Age < 18
- Prisoners
- Pregnant patients (medications are contraindicated)
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
About this study
Official title: Leveraging Evidence-based Practices for Ambulatory VTE and Other Patients to be Safe With Direct Oral Anticoagulants: LEAVE Safe With DOACs
Given the risks associated with direct oral anticoagulants (DOACs) and the lack of defined pathways for patients prescribed this class of medications, the study intervention has the potential for an enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and adherence with DOAC therapy.
Read the detailed description
Patients first treated with direct oral anticoagulants (DOACs) in an ambulatory setting are at an elevated risk for adverse drug events (ADEs) or potential ADEs from medication errors. An intervention that integrates clinical pharmacists, a pharmacy technician, and follows a checklist published by experts at the Anticoagulation Forum can prevent adverse outcomes. The Investigators propose research on the effectiveness, implementation, and dissemination for a care transition intervention that follows the checklist which includes evaluation for appropriateness of DOAC use, assistance with drug procurement, telephone access to an anticoagulation expert, and other best practice recommendations.
- Being tested
- Clinical Pharmacist Intervention
- Medical subject headings
- Cardiovascular Diseases, Venous Thromboembolism, Atrial Fibrillation, Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist InterventionOther
Also called Clinical Pharmacist Intervention Based on Checklist Endorsed by the AC Forum
After randomization, the pharmacist calls patients to assess drug choice and dose. Staff distribute manufacturer coupons and help patients apply for medication payment assistance. Pharmacist discusses DOAC alternatives with prescribe and provides DOAC education by discussing potential adverse effects, medication interactions, alarm symptoms, and lab work. Staff mail educational materials. Pharmacist documents concerns in the electronic health record and messages prescriber about missing lab work. Patients share medication-related concerns. Patients are provided with a phone number for non-education calls to discuss their medications from 6 AM - 10 PM on any day. The pharmacist offers dose de-escalation instructions based on the DOAC prescription. The pharmacist advises the continuity provider on DOAC duration and monitoring. For follow-up/perioperative support, the pharmacist reviews and recommends lab monitoring and gives DOAC interruption/resumption recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Clinical Pharmacist Intervention | Experimental | Not described Receives: Other: Clinical Pharmacist Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors
The number of preventable, ameliorable and potential Adverse Drug Events (ADEs) that physician reviewers attribute to Direct Oral Anticoagulant (DOAC) medication. Each DOAC related clinically important medication error is counted as a separate event, enabling patients to have multiple events consistent with the literature.
Measured: 90 Days Post Enrollment
Secondary outcomes (4)
Patient Knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) using the Anticoagulation and Venus Thromboembolism (VTE) knowledge questionnaire
Patient knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) will be evaluated using a modified version of a 22-item instrument previously developed and tested by the institution. This instrument assesses patients' knowledge of warning signs of bleeding and new VTE, interactions with other medications, and complications of VTE. A low score indicate a low level of knowledge and a high score indicates a high level of knowledge regarding anticoagulation and VTE.
Measured: 90 Days Post Enrollment
Number of missed or extra doses to assess medication adherence
Patients are asked to to count out the number of remaining pills from the last filled prescription and provide the fill date, number of pills dispensed, the schedule prescribed (either once or twice a day depending on DOAC), and skipped doses for deliberate interruption to determine medication adherence with the number of missed or extra doses.
Measured: 90 Days Post Enrollment
Medication Possession Ratio (MPR) to assess medication adherence
Medication adherence is measured with Medication Possession Ratio (MPR) which is the ratio between the time a patient had medication on hand, the time that a patient is eligible to have a medication on hand, and the time that a patient is covered by the medication. The MPR ratio will be calculated by using available pharmacy data.
Measured: 90 Days Post Enrollment
Proportion of days covered (PDC) to assess medication adherence
Proportion of Days Covered (PDC) is the ratio between the time that a patient has a medication on hand, the time that a patient is eligible to have a medication on hand, and the time that a patient is covered by the medication. Medication adherence will be evaluated using the mean PDC using available pharmacy data.
Measured: 90 Days Post Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start2 Dec 2019
- Primary completion1 Dec 2021
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Alok Kapoor, University of Massachusetts, Worcester
- Investigators
- Alok Kapoor, MD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068727
- Sponsor's protocol ID
- H00017891
- Other IDs
- 1R18HS02592401
- Status last verified
- Feb 2024
- First submitted
- 22 Aug 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kapoor A, Patel P, Mbusa D, Pham T, Cicirale C, Tran W, Beavers C, Javed S, Wagner J, Swain D, Crawford S, Darling C, ItoFuKunaga M, McManus D, Mazor K, Gurwitz J. Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants. J Gen Intern Med. 2023 Dec;38(16):3526-3534. doi: 10.1007/s11606-023-08315-z. Epub 2023 Sep 27.
PubMed 37758967Pham T, Patel P, Mbusa D, Kapoor A, Crawford S, Sadiq H, Rampam S, Wagner J, Gurwitz JH, Mazor KM. Impact of a pharmacist intervention on DOAC knowledge and satisfaction in ambulatory patients. J Thromb Thrombolysis. 2023 Feb;55(2):346-354. doi: 10.1007/s11239-022-02743-0. Epub 2022 Dec 12.
PubMed 36510110
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Evidence-based Practices for Ambulatory VTE and Other Patients to be Safe With Direct Oral Anticoagulants: LEAVE Safe With DOACs
- ClinicalTrials.gov ID
- NCT04068727
- Acronym / sponsor ID
- H00017891
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 28 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.
Given the risks associated with direct oral anticoagulants (DOACs) and the lack of defined pathways for patients prescribed this class of medications, the study intervention has the potential for an enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and adherence with DOAC therapy.
Detailed description
Patients first treated with direct oral anticoagulants (DOACs) in an ambulatory setting are at an elevated risk for adverse drug events (ADEs) or potential ADEs from medication errors. An intervention that integrates clinical pharmacists, a pharmacy technician, and follows a checklist published by experts at the Anticoagulation Forum can prevent adverse outcomes. The Investigators propose research on the effectiveness, implementation, and dissemination for a care transition intervention that follows the checklist which includes evaluation for appropriateness of DOAC use, assistance with drug procurement, telephone access to an anticoagulation expert, and other best practice recommendations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Clinical Pharmacist Intervention | Experimental | Other: Clinical Pharmacist Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- New prescription of DOAC within 4 days of consent OR continued DOAC use for a patient with new episode of worsening thromboembolic or bleeding event within 4 days of consent or discharged from the hospital with DOAC prescription within 4 days of consent
- Fluency in English, Portuguese, or Spanish
Key exclusion criteria (4 listed)
- Currently hospitalized with inpatient status (as opposed to observation status)
- Age < 18
- Prisoners
- Pregnant patients (medications are contraindicated)
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 |
|---|---|---|
| Clinical Pharmacist InterventionAlso: Clinical Pharmacist Intervention Based on Checklist Endorsed by the AC ForumAfter randomization, the pharmacist calls patients to assess drug choice and dose. Staff distribute manufacturer coupons and help patients apply for medication payment assistance. Pharmacist discusses DOAC alternatives with prescribe and provides DOAC education by discussing potential adverse effects, medication interactions, alarm symptoms, and lab work. Staff mail educational materials. Pharmacist documents concerns in the electronic health record and messages prescriber about missing lab work. Patients share medication-related concerns. Patients are provided with a phone number for non-education calls to discuss their medications from 6 AM - 10 PM on any day. The pharmacist offers dose de-escalation instructions based on the DOAC prescription. The pharmacist advises the continuity provider on DOAC duration and monitoring. For follow-up/perioperative support, the pharmacist reviews and recommends lab monitoring and gives DOAC interruption/resumption recommendations. | Other | Clinical Pharmacist Intervention |
Primary outcome
Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors
Time frame: 90 Days Post Enrollment
The number of preventable, ameliorable and potential Adverse Drug Events (ADEs) that physician reviewers attribute to Direct Oral Anticoagulant (DOAC) medication. Each DOAC related clinically important medication error is counted as a separate event, enabling patients to have multiple events consistent with the literature.
4 secondary outcomes
Patient Knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) using the Anticoagulation and Venus Thromboembolism (VTE) knowledge questionnaire
Time frame: 90 Days Post Enrollment
Number of missed or extra doses to assess medication adherence
Time frame: 90 Days Post Enrollment
Medication Possession Ratio (MPR) to assess medication adherence
Time frame: 90 Days Post Enrollment
Proportion of days covered (PDC) to assess medication adherence
Time frame: 90 Days Post Enrollment
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 20 Feb 2024.
- Derived from this study: PubMed 37758967Kapoor A, Patel P, Mbusa D, Pham T, Cicirale C, Tran W, Beavers C, Javed S, Wagner J, Swain D, Crawford S, Darling C, ItoFuKunaga M, McManus D, Mazor K, Gurwitz J. Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants. J Gen Intern Med. 2023 Dec;38(16):3526-3534. doi: 10.1007/s11606-023-08315-z. Epub 2023 Sep 27.
- Derived from this study: PubMed 36510110Pham T, Patel P, Mbusa D, Kapoor A, Crawford S, Sadiq H, Rampam S, Wagner J, Gurwitz JH, Mazor KM. Impact of a pharmacist intervention on DOAC knowledge and satisfaction in ambulatory patients. J Thromb Thrombolysis. 2023 Feb;55(2):346-354. doi: 10.1007/s11239-022-02743-0. Epub 2022 Dec 12.
- 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.
Alok Kapoor, MD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pharmacist Intervention in people with Cardiovascular Diseases and Venous Thromboembolism, run by University of Massachusetts, Worcester at 1 site in United States.
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 3 inclusion and 4 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors (time frame: 90 Days Post Enrollment). 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 NCT04068727, which also lists 2 linked publications.
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 20 Feb 2024.