跳至主要内容
临床试验/NCT00132145
NCT00132145已完成不适用

A Randomized Trial of Electronic Integration of Care for Better Vascular Outcomes: The Compete III Study Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness (COMPETE III)

St. Joseph's Healthcare Hamilton1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2003年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
1
主要终点
The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups.

研究概览

简要总结

Vascular diseases (cardiac events, strokes, peripheral vascular disease) remain the number one killer in Canadian society as well as the leading cause of hospitalization and days spent in the hospital. A 1996 estimate placed Ontario's vascular disease financial burden at $5.5 billion in total. Any intervention which lowers vascular risk, will have a direct impact on the quantity and quality of life and costs of health care. Further integration of health professionals in teams focused on chronic disease management in individuals and populations is also ripe for further evaluation. Increased collaboration between family physicians, physician specialists, nurse practitioners, and pharmacists are generally thought to be beneficial for patient outcomes, but the literature is inconclusive and their cost-effectiveness is unproven. In addition, combining centralized electronic up-to-date information on the patient's status with evidence-based recommendations and the ability to communicate either electronically or by phone is expected to result in improved access to care, quality of care, continuity of care and increase cost-effectiveness of chronic disease management.

COMPETE III builds on the researchers' previous work to study an electronic vascular tracking and decision support system shared by patients and their physicians, combined with a clinical care coordinator and automated telephone support system. The researchers are evaluating its impact on vascular risk processes and outcomes, perceived usefulness, ease of use, need for improvement, medication adherence, quality of life and patient goals and motivation.

Study hypothesis: Patients at increased risk of vascular events, if connected with their family physicians, medical specialists and care coordinator via an electronic network (Web, fax and telephone) sharing an intensive tracking, advice and support program, will lower their vascular risk more than those in usual care.

详细描述

COMPETE is Canada's original electronic medical record research network and specializes in the rigorous development, implementation and evaluation of electronic technologies in health care. COMPETE III will build on COMPETE II to incorporate the latest evidence on:

  1. the management of diabetes, hypertension, dyslipidemia and previous vascular events,
  2. improving patient-clinician interactions,
  3. the use of technology to enhance the quality, safety and efficiency of care and
  4. motivational strategies to change both patient and clinician behaviour.

Specifically, the researchers will:

  1. Expand the disease focus to a vascular risk population (diabetes, hypertension, dyslipidemia or previous vascular event);
  2. Expand the electronic care network beyond patients and primary care providers to also include specialists (physician specialists, specialty nurse clinicians, etc);
  3. Expand the geographical network from Hamilton area, and Ottawa to include other primary care reform (PCR), Ontario Family Health Networks (OFHN) or EHR using sites;
  4. Tighten the integration with the leading Ontario EHR products and concentrate on those meeting the new Ontario Smart Systems for Health Clinical Management System specifications,
  5. Strengthen the clinical decision support by offering evidence-based algorithms specific to the patient, provide specific formulary advice - drug listing, Limited Use prescriptions and codes, Section 8 criteria and form letters;
  6. Improve the researchers pharmacosurveillance network which pursues reasons for starting and stopping medications by seeking adherence information directly from patients;
  7. Provide direct links via Internet for patients and clinicians to best evidence about vascular disease,
  8. Improve the automated telephone support (ATS);
  9. Support physicians in managing this advanced care network by providing clinical care coordinators, either nurse clinicians or clinical pharmacists;
  10. Use HL-7 messaging standards as per Canada Health Infoway guidelines;
  11. Rigorously evaluate the cost-effectiveness of our package intervention in order to provide specific advice to health planners and payers on costs and benefits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •55 years of age and over
  • •Regular patients of a family physician's office (at least one visit in the last 12 months)
  • •Vascular disease (previous myocardial infarction, stroke, peripheral vascular disease, coronary artery disease) or at least one of the following vascular risk factors (hypertension, hypercholesterolemia, diabetes)

排除标准

  • •Non-English speaking
  • •Cognitive impairment

研究组 & 干预措施

Intervention

Other

Behavioural

干预措施: Vascular Management Program (Behavioral)

Intervention

Other

Behavioural

干预措施: Clinical Care Coordinators (Behavioral)

Intervention

Other

Behavioural

干预措施: Web-based Vascular Tracker for Patient and Physician (Behavioral)

Intervention

Other

Behavioural

干预措施: Automated Telephone Reminder System (Behavioral)

结局指标

主要结局

The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups.

时间窗: 6 months to 1 year

次要结局

  • Vascular outcome targets(6 months to 1 year)
  • Provider satisfaction, perceived value(6 months to 1 year)
  • Patient satisfaction, self-efficacy, access to care(6 months to 1 year)
  • Health care utilization(6 months to 1 year)
  • Patient Quality of Life(6 months to 1 year)
  • Cost effectiveness(6 months to 1 year)
  • Facilitators, predictors and barriers to the success of project(1 year)
  • Health data privacy and security(6 months to 1 year)
  • Scalability and sustainability(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Anne Holbrook

Director, Division of Pharmacology & Toxicology

St. Joseph's Healthcare Hamilton

研究点 (1)

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