The Potential of Technology to Improve Chronic Disease Management and Quality of Care

This study has been completed.
Sponsor:
Information provided by:
Robert Wood Johnson Foundation
ClinicalTrials.gov Identifier:
NCT00221455
First received: September 15, 2005
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

We seek to determine if patient data entry, data entered based alerts, and data review in a secure patient portal may provide a sustainable approach to improve diabetic outcomes in a cost effective manner. We plan to study the extent to which the portal can improve diabetic outcomes and quality of care. We recognize, however, that some patients will be more predisposed to adopting technology and some will be more predisposed to improving their compliance than others. Hence, we will also develop and test interventions that may improve adoption and compliance. The goals of the proposed study are: 1) to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; and 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens.


Condition Intervention Phase
Diabetes Mellitus
Behavioral: Patient diabetic self-management using the diabetic patient portal tools
Behavioral: A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Potential of Technology to Improve Chronic Disease Management and Quality of Care

Resource links provided by NLM:


Further study details as provided by Robert Wood Johnson Foundation:

Primary Outcome Measures:
  • Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.

Secondary Outcome Measures:
  • Technology Adoption will be measured by tracking the patient usage of the various portal features

Estimated Enrollment: 1000
Study Start Date: September 2004
Study Completion Date: September 2007
Detailed Description:

To date, limited research has been conducted to determine if health information technology (HIT) is effective in improving the outcomes for patients with chronic diseases. Research is required to determine if interventions facilitated by an institutional EMR platform can be implemented such that they support patients with chronic diseases to achieve improved outcomes in a cost effective fashion.

At the Cleveland Clinic Foundation (CCF) an ambulatory EMR has been implemented to foster patient safety and institutional best practice guidelines, to facilitate research, and to achieve efficiencies in practice management. Our EMR is the foundation of the CCF patient portal. One of the functions of the portal is to allow patients to enter specific data elements that become part of their permanent medical record. Diabetics can enter and review their home glucometer readings, and view alert messages based on their entries. The entries are transferred to the patient's primary care physician's EMR In-Basket for review.

We recognize that some patients will be more predisposed to technology adoption and some will be more health behavior compliant than others. Therefore, in addition to studying our portal's efficacy in positive diabetic behavior change, we will test if interventions can assist less predisposed and less compliant patients to become more compliant and more inclined to adopt the technology.

The goals of the proposed study are:

1) to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Diabetic patients 18 years of age or older with an established primary care physician at the Cleveland Clinic Foundation

Exclusion Criteria: An individual not meeting the inclusion criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221455

Locations
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Martin Harris, MD, MBA The Cleveland Clinic
Study Director: Holly D Miller, MD, MBA The Cleveland Clinic
  More Information

Additional Information:
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ClinicalTrials.gov Identifier: NCT00221455     History of Changes
Other Study ID Numbers: 51760, 51760
Study First Received: September 15, 2005
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Robert Wood Johnson Foundation:
Diabetes Mellitus
Chronic disease management
Patient portal
Patient empowerment

Additional relevant MeSH terms:
Chronic Disease
Diabetes Mellitus
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014