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Completed

NCT Number: NCT02870296

Anticoagulation Medical Home

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Patient-centered Care Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Medical School

Worcester, Massachusetts, 01566, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Enhanced Assessment and Education

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Pfizer

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 17, 2016
Registry last updated
Nov 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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