Anticoagulation Medical Home
Primary Purpose
Venous Thromboembolism, Patient-Centered Care
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Assessment and Education
Sponsored by
About this trial
This is an interventional health services research trial for Venous Thromboembolism
Eligibility 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).
Sites / Locations
- UMass Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
The control group will receive usual care; no interventions will be administered.
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).
Outcomes
Primary Outcome Measures
Care Transition Measure (CTM-15)
15 item measure; measures 4 aspects of quality of transitional care
Secondary Outcome Measures
Clinical Outcome: VTE Recurrence
Measure the difference in recurrent VTE between intervention and comparison groups.
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.
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.
Clinical Outcome: Mortality
Measure the difference in mortality between intervention and comparison groups.
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.
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
Full Information
NCT ID
NCT02870296
First Posted
June 10, 2016
Last Updated
November 15, 2018
Sponsor
University of Massachusetts, Worcester
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02870296
Brief Title
Anticoagulation Medical Home
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 21, 2016 (Actual)
Primary Completion Date
November 3, 2017 (Actual)
Study Completion Date
January 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Patient-Centered Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive usual care; no interventions will be administered.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Assessment and Education
Intervention Description
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 Measure Information:
Title
Care Transition Measure (CTM-15)
Description
15 item measure; measures 4 aspects of quality of transitional care
Time Frame
30 days post hospital discharge
Secondary Outcome Measure Information:
Title
Clinical Outcome: VTE Recurrence
Description
Measure the difference in recurrent VTE between intervention and comparison groups.
Time Frame
30 and 90 days post hospital discharge
Title
Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report)
Description
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.
Time Frame
30 and 90 days post hospital discharge
Title
Clinical Outcome: Hospital Readmission (any unplanned hospital admissions noted in Medical Record and/or via patient self-report)
Description
Measure the difference between all cause hospital readmission (post-diagnosis of VTE) between intervention and comparison groups.
Time Frame
30 and 90 days post hospital discharge
Title
Clinical Outcome: Mortality
Description
Measure the difference in mortality between intervention and comparison groups.
Time Frame
30 and 90 days post hospital discharge
Title
Other Measure: Patient Knowledge (via questionnaire developed by Mazor et. al. 2007 Patient Educ Counsel and via investigator developed items)
Description
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.
Time Frame
30 and 90 days post hospital discharge
Title
Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire)
Description
Measure health-related quality of life for patients on warfarin and time in the therapeutic range (TTR) in our target population
Time Frame
30 and 90 days post hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alok Kapoor, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01566
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31965873
Citation
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.
Results Reference
derived
PubMed Identifier
30702452
Citation
Kapoor 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.
Results Reference
derived
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