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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Care Transition Measure (CTM-15)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Not engaged in Primary Care (has not seen a Primary Care Practitioner within the previous 18 months).
研究组 & 干预措施
Control
The control group will receive usual care; no interventions will be administered.
Intervention
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).
干预措施: Enhanced Assessment and Education (Behavioral)
结局指标
主要结局
Care Transition Measure (CTM-15)
时间窗: 30 days post hospital discharge
15 item measure; measures 4 aspects of quality of transitional care
次要结局
- Clinical Outcome: VTE Recurrence(30 and 90 days post hospital discharge)
- Other Measure: Quality of Life (VEINES-QOL/Sym questionnaire or PEmb-QoL questionnaire)(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)
- 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)
- 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)
研究者
Alok Kapoor
Principal Investigator
University of Massachusetts, Worcester