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Adult Trials: 18+ Years
- 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.
- Not engaged in Primary Care (has not seen a Primary Care Practitioner within the
previous 18 months).
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- Worcester, Massachusetts
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Anticoagulation Medical Home | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research | ||||
| Condition ICMJE |
| ||||
| Intervention ICMJE | Behavioral: Enhanced Assessment and Education
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 Arms ICMJE |
| ||||
| 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE | 162 | ||||
| Original Estimated Enrollment ICMJE | 200 | ||||
| Actual Study Completion Date ICMJE | January 5, 2018 | ||||
| Actual Primary Completion Date | November 3, 2017 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender ICMJE |
| ||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT02870296 | ||||
| Other Study ID Numbers ICMJE | H00010242 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Alok Kapoor, University of Massachusetts, Worcester | ||||
| Study Sponsor ICMJE | University of Massachusetts, Worcester | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
| ||||
| PRS Account | University of Massachusetts, Worcester | ||||
| Verification Date | November 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||