NCT00421850

Brief Summary

The costs of diabetes care (in health care dollars \& human suffering) in the United States are second only to mental illness. Randomized control trials \& observational studies have shown that glycemic control is predictive of the onset \& severity of complications from diabetes and costs of care. In addition, a significant percentage of costs associated with diabetes can be reduced or delayed by appropriate diagnosis, preventive strategies, \& management. The Planned Care Model (advocated by the Institute for Healthcare Improvement) has shown success in demonstrating improved practice performance and patient outcomes during a limited pilot in our clinical practice. We are proposing to generalize the Planned Care Model, to assess the value of planned care for all people with diabetes. The Planned Care Model will be implemented at each practice site and will consist of a structured communication schema between the patient and the primary health care team, to improve care for people with diabetes. Traditional care will be defined as the traditional system of care for patients prior to their participation in the Planned Care Model. It is hypothesized that this Planned Care Model will improve compliance with appropriate care guidelines and improve short and long term health outcomes (metabolic, satisfaction, morbidity, mortality and healthcare utilization). In conjunction with this study, providers at each of the practice sites will be randomly assigned to a structured communication with specialty care, referred to as UNITED Planned Care (Use of Networks, Informatics, Telemedicine, and Education in Disease Management). This communication schema will only be possible once the assigned provider?s patient is participating in the Planned Care Model. The UNITED Planned Care model will include point-of-care evidence based messages and specialty advice determined by performance gaps and outcomes for the patient. UNITED Planned Care is hypothesized to have the greatest impact on short \& long term health outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,491

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
Last Updated

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

3.5 years

First QC Date

January 11, 2007

Last Update Submit

May 20, 2011

Conditions

Outcome Measures

Primary Outcomes (5)

  • Processes of clinical care for diabetes

  • Cardiovascular risk as determined by UKPDS Risk

  • Metabolic outcomes (HgbA1c)

  • Metabolic outcomes (LDL Cholesterol)

  • Metabolic Outcomes (Systolic Blood Pressure)

Secondary Outcomes (2)

  • Health Care Utlization and Costs

  • Satisfaction (Provider and Health Team)

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients in primary care referred to Diabetes Educator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Smith SA, Shah ND, Bryant SC, Christianson TJ, Bjornsen SS, Giesler PD, Krause K, Erwin PJ, Montori VM; Evidens Research Group. Chronic care model and shared care in diabetes: randomized trial of an electronic decision support system. Mayo Clin Proc. 2008 Jul;83(7):747-57. doi: 10.4065/83.7.747.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Steven A. Smith, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 12, 2007

Study Start

July 1, 2001

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations