Viewing Study NCT00132145



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Study NCT ID: NCT00132145
Status: COMPLETED
Last Update Posted: 2016-10-19
First Post: 2005-08-17

Brief Title: Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness COMPETE III
Sponsor: St Josephs Healthcare Hamilton
Organization: St Josephs Healthcare Hamilton

Study Overview

Official Title: 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
Status: COMPLETED
Status Verified Date: 2016-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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 Ontarios vascular disease financial burden at 55 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 patients 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
Detailed Description: COMPETE is Canadas 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None