Anticoagulation Medical Home

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870296
• Other study ID #: H00010242
• Status: Completed
• Phase: N/A
• Start date: October 21, 2016
• Est. completion date: January 5, 2018

Study information

• Verified date: November 2018
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 5, 2018
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Patient-Centered Care
• Thromboembolism
• Venous Thromboembolism

Intervention

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).

Locations

Country	Name	City	State
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Care Transition Measure (CTM-15)	15 item measure; measures 4 aspects of quality of transitional care	30 days post hospital discharge
Secondary	Clinical Outcome: VTE Recurrence	Measure the difference in recurrent VTE between intervention and comparison groups.	30 and 90 days post hospital discharge
Secondary	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.	30 and 90 days post hospital discharge
Secondary	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.	30 and 90 days post hospital discharge
Secondary	Clinical Outcome: Mortality	Measure the difference in mortality between intervention and comparison groups.	30 and 90 days post hospital discharge
Secondary	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.	30 and 90 days post hospital discharge
Secondary	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	30 and 90 days post hospital discharge