A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study - Full Text View

Sponsors and Collaborators:	McMaster University Health, Canada
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00813085

Purpose

This study will evaluate whether the use of an electronic diabetes tracker by both patients and family physicians in Ontario improves diabetes outcomes, satisfaction with care and with technology and health data privacy issues.

As part of the study, the investigators will be able to test whether practices that use computers perform any better than practices using paper. The investigators also will be developing the first Canadian computerized chart summary for each patient that can be communicated securely in emergencies (the Emergency Health Record) and read by all current electronic systems.

Condition	Intervention
Diabetes	Other: Electronic disease management decision support

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial of Electronic Integration of Care for Better Diabetes Outcomes; The COMPETE II Study

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:

Comparison of change in diabetes quality of care between intervention and usual care group. [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in diabetes risk factor variables, satisfaction with care and technology, quality of life and health care utilization, health data privacy issues. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	511
Study Start Date:	April 2002
Study Completion Date:	December 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Electronic disease management decision support An electronic Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS).	Other: Electronic disease management decision support A Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS)
2: No Intervention Usual care by Family Physician

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult, cognitively intact, consenting people with diabetes within enrolled practices

Exclusion Criteria:

Non-english speaking
Cognitively impaired

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813085

Locations

Canada, Ontario
St Joseph's Healthcare & Mcmaster University
Hamilton, Ontario, Canada

Sponsors and Collaborators

McMaster University

Health, Canada

Investigators

Principal Investigator:

Anne M Holbrook, MD,PharmD,MSc

McMaster University

More Information

Additional Information:

COMPETE group website for all series of Compete trials and work This link exits the ClinicalTrials.gov site

No publications provided by McMaster University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Holbrook A, Thabane L, Keshavjee K, Dolovich L, Bernstein B, Chan D, Troyan S, Foster G, Gerstein H; COMPETE II Investigators. Individualized electronic decision support and reminders to improve diabetes care in the community: COMPETE II randomized trial. CMAJ. 2009 Jul 7;181(1-2):37-44.

Responsible Party:	St Joseph's Healthcare ( Anne M Holbrook, PharmD, MD, MSc )
Study ID Numbers:	02-2068
Study First Received:	December 18, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00813085 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

Diabetes
Computerized clinical decision support
shared care
patient self-monitoring

quality of care
complex interventions
composite outcomes

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 28, 2009