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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02870296
Other study ID # H00010242
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


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
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