Anticoagulation Medical Home

Not Applicable

Completed

• Conditions: Patient-Centered Care; Venous Thromboembolism
• Interventions: Behavioral: Enhanced Assessment and Education

• Registration Number: NCT02870296
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Study Start: 2016-10-21
• Primary Completion: 2017-11-03
• Study Completion: 2018-01-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Enhanced Assessment and Education	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).

Primary Outcome Measures

Name	Time	Method
Care Transition Measure (CTM-15)	30 days post hospital discharge	15 item measure; measures 4 aspects of quality of transitional care

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome: VTE Recurrence	30 and 90 days post hospital discharge	Measure the difference in recurrent VTE between intervention and comparison groups.
Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire)	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
Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report)	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.
Other Measure: Patient Knowledge (via questionnaire developed by Mazor et. al. 2007 Patient Educ Counsel and via investigator developed items)	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.
Clinical Outcome: Hospital Readmission (any unplanned hospital admissions noted in Medical Record and/or via patient self-report)	30 and 90 days post hospital discharge	Measure the difference between all cause hospital readmission (post-diagnosis of VTE) between intervention and comparison groups.
Clinical Outcome: Mortality	30 and 90 days post hospital discharge	Measure the difference in mortality between intervention and comparison groups.

Trial Locations

Locations (1)

UMass Medical School; 🇺🇸 Worcester, Massachusetts, United States