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

NCT00813085 | Completed

• 1 other identifier: 02-2068
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes

Keywords

Diabetes; Computerized clinical decision support; shared care; patient self-monitoring; quality of care; complex interventions; composite outcomes

Outcome Measures

Primary Outcomes (1)

• Comparison of change in diabetes quality of care between intervention and usual care group.

  6 months follow-up

Secondary Outcomes (1)

• Change in diabetes risk factor variables, satisfaction with care and technology, quality of life and health care utilization, health data privacy issues.

  6 months

Study Arms (2)

Electronic disease management decision support

OTHER

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

2

NO INTERVENTION

Usual care by Family Physician

Interventions

Electronic disease management decision support OTHER

A Diabetes Tracker embedded in a Core Data Set (DT/CDS) supported by an automated telephone reminder system (ATRS)

Also known as: Intervention

Electronic disease management decision support

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non-english speaking
• Cognitively impaired

Sponsors & Collaborators

• McMaster University: lead
• Health Canada: collaborator

Study Sites (1)

St Joseph's Healthcare & Mcmaster University

Hamilton, Ontario, Canada

Location

Related Publications (1)

• 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. doi: 10.1503/cmaj.081272.

  PMID: 19581618 DERIVED

Related Links

• COMPETE group website for all series of Compete trials and work

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Methods

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Anne M Holbrook, MD,PharmD,MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 22, 2008
• Study Start: April 1, 2002
• Primary Completion: September 1, 2003
• Study Completion: December 1, 2003
• Last Updated: December 22, 2008

Record last verified: 2008-12

Locations

CA (1)