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Anticoagulation Medical Home

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ClinicalTrials.gov Identifier: NCT02870296
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Alok Kapoor, University of Massachusetts, Worcester

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.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Patient-Centered Care Behavioral: Enhanced Assessment and Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : October 21, 2016
Actual Primary Completion Date : November 3, 2017
Actual Study Completion Date : January 5, 2018

Arm Intervention/treatment
No Intervention: Control
The control group will receive usual care; no interventions will be administered.
Experimental: Intervention
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).
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).




Primary Outcome Measures :
  1. Care Transition Measure (CTM-15) [ Time Frame: 30 days post hospital discharge ]
    15 item measure; measures 4 aspects of quality of transitional care


Secondary Outcome Measures :
  1. Clinical Outcome: VTE Recurrence [ Time Frame: 30 and 90 days post hospital discharge ]
    Measure the difference in recurrent VTE between intervention and comparison groups.

  2. Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report) [ Time Frame: 30 and 90 days post hospital discharge ]

    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.


  3. 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 ]
    Measure the difference between all cause hospital readmission (post-diagnosis of VTE) between intervention and comparison groups.

  4. Clinical Outcome: Mortality [ Time Frame: 30 and 90 days post hospital discharge ]
    Measure the difference in mortality between intervention and comparison groups.

  5. 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 ]
    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.

  6. Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire) [ Time Frame: 30 and 90 days post hospital discharge ]
    Measure health-related quality of life for patients on warfarin and time in the therapeutic range (TTR) in our target population



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Not engaged in Primary Care (has not seen a Primary Care Practitioner within the previous 18 months).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870296


Locations
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United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01566
Sponsors and Collaborators
University of Massachusetts, Worcester
Pfizer
Investigators
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Principal Investigator: Alok Kapoor, MD University of Massachusetts, Worcester

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Responsible Party: Alok Kapoor, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02870296     History of Changes
Other Study ID Numbers: H00010242
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases