Venous ThromboembolismNCT02870296
Anticoagulation Medical Home
A study testing Enhanced Assessment and Education in people with Venous Thromboembolism and Patient-Centered Care, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The primary study goal is to improve the quality of care transitions for patients with new episodes of venous thromboembolism (VTE). Primary Outcomes: To measure differences in the quality of care transition, as measured by the Care Transition Measure (CTM)-15 in the investigators target population of patients with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism, Patient-Centered Care
- What is being tested?
- Enhanced Assessment and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2016to 5 Jan 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
- hospital admission;
- diagnosis of:
- VTE (first or subsequent episode); or
- DVT of leg or pelvis or upper extremities or other site confirmed by ultrasound or CT scan; or
- PE with a positive CT spiral exam, pulmonary arteriogram, CT angiogram, or high probability ventilation perfusion scan.
- for whom it is anticipated the treating medical team will prescribe an oral anticoagulant upon hospital discharge.
Who cannot join
- Not engaged in Primary Care (has not seen a Primary Care Practitioner within the previous 18 months).
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01566
About this study
Official title: Anticoagulation Medical Home for High-Risk Patients With Venous Thromboembolism: Patient Education, Anticoagulant Decision-Making, and Patient Self-Efficacy in the Home Coordinated by the UMass Anticoagulation Team
The primary study goal is to improve the quality of care transitions for patients with new episodes of venous thromboembolism (VTE).
Primary Outcomes: To measure differences in the quality of care transition, as measured by the Care Transition Measure (CTM)-15 in the investigators target population of patients with incident VTE randomized to either a multicomponent, anticoagulation medical home intervention or usual care.
Read more
Secondary Major Outcomes: To measure the difference in recurrent VTE, major hemorrhage, all-cause re-admissions, and mortality between the investigators intervention and comparison groups at 30 and 90 days in the investigators target population.
Secondary Other Outcomes: To measure patient knowledge, health-related quality of life, and time in the therapeutic range (TTR) for patients on warfarin in the investigators target population.
- Conditions
- Venous Thromboembolism, Patient-Centered Care
- Being tested
- Enhanced Assessment and Education
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Assessment and EducationBehavioural
Patients in the Intervention Group will: 1) have an in-home pharmacist medication assessment; 2) receive enhanced medication instructions (including pictograms); 3) receive an additional individualized assessment and educational session with a clinician provider related to the medication management for their disease (VTE).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive usual care; no interventions will be administered. |
| Intervention | Experimental | Interventions will be administered to this group. Patients in the Intervention Group will: 1) have an in-home pharmacist medication assessment; 2) receive enhanced medication instructions (including pictograms); 3) receive an additional individualized assessment and educational session with a clinician provider related to the medication management for their disease (VTE). Receives: Behavioral: Enhanced Assessment and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Transition Measure (CTM-15)
15 item measure; measures 4 aspects of quality of transitional care
Measured: 30 days post hospital discharge
Secondary outcomes (6)
Clinical Outcome: VTE Recurrence
Measure the difference in recurrent VTE between intervention and comparison groups.
Measured: 30 and 90 days post hospital discharge
Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report)
Measure the difference in major hemorrhage between intervention and comparison groups- ISTH 2005 medical definition 14 - 2 unit drop in hemoglobin, 2 unit transfusion, or critical site bleed.
- ISTH 2009 surgical definition 15 - surgical site 2 unit drop or 2 unit transfusion with increase in LOS, hemodynamic compromise, delay in rehab.
Measured: 30 and 90 days post hospital discharge
Clinical Outcome: Hospital Readmission (any unplanned hospital admissions noted in Medical Record and/or via patient self-report)
Measure the difference between all cause hospital readmission (post-diagnosis of VTE) between intervention and comparison groups.
Measured: 30 and 90 days post hospital discharge
Clinical Outcome: Mortality
Measure the difference in mortality between intervention and comparison groups.
Measured: 30 and 90 days post hospital discharge
Other Measure: Patient Knowledge (via questionnaire developed by Mazor et. al. 2007 Patient Educ Counsel and via investigator developed items)
Measure patient knowledge and attitudes Mazor KM, Baril J, Dugan E, Spencer F, Burgwinkle P, Gurwitz JH. Patient education about anticoagulant medication: is narrative evidence or statistical evidence more effective? Patient Educ Couns. 2007 Dec;69(1-3):145-57. Epub 2007 Oct 17.
Measured: 30 and 90 days post hospital discharge
Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire)
Measure health-related quality of life for patients on warfarin and time in the therapeutic range (TTR) in our target population
Measured: 30 and 90 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start21 Oct 2016
- Primary completion3 Nov 2017
- Study completion5 Jan 2018
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 Venous ThromboembolismStudies 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
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Alok Kapoor, University of Massachusetts, Worcester
- Investigators
- Alok Kapoor, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870296
- Sponsor's protocol ID
- H00010242
- Status last verified
- Nov 2018
- First submitted
- 10 Jun 2016
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kapoor A, Bloomstone S, Javed S, Silva M, Lynch A, Yogaratnam D, Carlone B, Springer K, Maheswaran A, Chen X, Nagy A, Elhag R, Markaddy E, Aungst T, Bartlett D, Houng D, Darling C, McManus D, Herzig SJ, Barton B, Mazor K. Reducing Hospitalizations and Emergency Department Visits in Patients With Venous Thromboembolism Using a Multicomponent Care Transition Intervention. Inquiry. 2020 Jan-Dec;57:46958019900080. doi: 10.1177/0046958019900080.
PubMed 31965873Kapoor A, Landyn V, Wagner J, Burgwinkle P, Huang W, Gore J, Spencer FA, Goldberg R, McManus DD, Darling C, Boudreaux E, Barton B, Mazor KM. Supplying Pharmacist Home Visit and Anticoagulation Professional Consultation During Transition of Care for Patients With Venous Thromboembolism. J Patient Saf. 2020 Dec;16(4):e367-e375. doi: 10.1097/PTS.0000000000000571.
PubMed 30702452
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation Medical Home for High-Risk Patients With Venous Thromboembolism: Patient Education, Anticoagulant Decision-Making, and Patient Self-Efficacy in the Home Coordinated by the UMass Anticoagulation Team
- ClinicalTrials.gov ID
- NCT02870296
- Acronym / sponsor ID
- H00010242
- Conditions
- Venous Thromboembolism, Patient-Centered Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 17 Aug 2016 (estimated)
- 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 primary study goal is to improve the quality of care transitions for patients with new episodes of venous thromboembolism (VTE).
Primary Outcomes: To measure differences in the quality of care transition, as measured by the Care Transition Measure (CTM)-15 in the investigators target population of patients with incident VTE randomized to either a multicomponent, anticoagulation medical home intervention or usual care.
Secondary Major Outcomes: To measure the difference in recurrent VTE, major hemorrhage, all-cause re-admissions, and mortality between the investigators intervention and comparison groups at 30 and 90 days in the investigators target population.
Secondary Other Outcomes: To measure patient knowledge, health-related quality of life, and time in the therapeutic range (TTR) for patients on warfarin in the investigators target population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive usual care; no interventions will be administered. |
| Intervention | Experimental | Behavioral: Enhanced Assessment and EducationInterventions will be administered to this group. Patients in the Intervention Group will: 1) have an in-home pharmacist medication assessment; 2) receive enhanced medication instructions (including pictograms); 3) receive an additional individualized assessment and educational session with a clinician provider related to the medication management for their disease (VTE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- hospital admission;
- diagnosis of:
- for whom it is anticipated the treating medical team will prescribe an oral anticoagulant upon hospital discharge.
Key exclusion criteria (1 listed)
- Not engaged in Primary Care (has not seen a Primary Care Practitioner within the previous 18 months).
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 |
|---|---|---|
| Enhanced Assessment and EducationPatients in the Intervention Group will: 1) have an in-home pharmacist medication assessment; 2) receive enhanced medication instructions (including pictograms); 3) receive an additional individualized assessment and educational session with a clinician provider related to the medication management for their disease (VTE). | Behavioural | Intervention |
Primary outcome
Care Transition Measure (CTM-15)
Time frame: 30 days post hospital discharge
15 item measure; measures 4 aspects of quality of transitional care
6 secondary outcomes
Clinical Outcome: VTE Recurrence
Time frame: 30 and 90 days post hospital discharge
Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report)
Time frame: 30 and 90 days post hospital discharge
Clinical Outcome: Hospital Readmission (any unplanned hospital admissions noted in Medical Record and/or via patient self-report)
Time frame: 30 and 90 days post hospital discharge
Clinical Outcome: Mortality
Time frame: 30 and 90 days post hospital discharge
Other Measure: Patient Knowledge (via questionnaire developed by Mazor et. al. 2007 Patient Educ Counsel and via investigator developed items)
Time frame: 30 and 90 days post hospital discharge
Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire)
Time frame: 30 and 90 days post hospital discharge
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 16 Nov 2018.
- Derived from this study: PubMed 31965873Kapoor A, Bloomstone S, Javed S, Silva M, Lynch A, Yogaratnam D, Carlone B, Springer K, Maheswaran A, Chen X, Nagy A, Elhag R, Markaddy E, Aungst T, Bartlett D, Houng D, Darling C, McManus D, Herzig SJ, Barton B, Mazor K. Reducing Hospitalizations and Emergency Department Visits in Patients With Venous Thromboembolism Using a Multicomponent Care Transition Intervention. Inquiry. 2020 Jan-Dec;57:46958019900080. doi: 10.1177/0046958019900080.
- Derived from this study: PubMed 30702452Kapoor A, Landyn V, Wagner J, Burgwinkle P, Huang W, Gore J, Spencer FA, Goldberg R, McManus DD, Darling C, Boudreaux E, Barton B, Mazor KM. Supplying Pharmacist Home Visit and Anticoagulation Professional Consultation During Transition of Care for Patients With Venous Thromboembolism. J Patient Saf. 2020 Dec;16(4):e367-e375. doi: 10.1097/PTS.0000000000000571.
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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
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Assessment and Education in people with Venous Thromboembolism and Patient-Centered Care, 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 6 inclusion and 1 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 16 Nov 2018. 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?
Care Transition Measure (CTM-15) (time frame: 30 days post hospital discharge). 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 NCT02870296, 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 16 Nov 2018.