Anticoagulation Medical Home

NCT02870296 | Completed

• 1 other identifier: H00010242
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism; Patient-Centered Care

Outcome Measures

Primary Outcomes (1)

• Care Transition Measure (CTM-15)

  15 item measure; measures 4 aspects of quality of transitional care

  30 days post hospital discharge

Secondary Outcomes (6)

• Clinical Outcome: VTE Recurrence

  30 and 90 days post hospital discharge

• Clinical Outcome: Major Hemorrhage (noted in Medical Record and/or via patient self-report)

  30 and 90 days post hospital discharge

• 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

• Clinical Outcome: Mortality

  30 and 90 days post hospital discharge

• 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

Study Arms (2)

Control

NO INTERVENTION

The control group will receive usual care; no interventions will be administered.

Intervention

EXPERIMENTAL

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).

Behavioral: Enhanced Assessment and Education

Interventions

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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not engaged in Primary Care (has not seen a Primary Care Practitioner within the previous 18 months).

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Pfizer: collaborator

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01566, United States

Location

Related Publications (2)

• 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.

  PMID: 31965873 DERIVED

• 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.

  PMID: 30702452 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Alok Kapoor, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: August 17, 2016
• Study Start: October 21, 2016
• Primary Completion: November 3, 2017
• Study Completion: January 5, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

US (1)