The Potential of Technology to Improve Chronic Disease Management and Quality of Care
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Patient diabetic self-management using the diabetic patient portal tools
A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Chronic disease management, Patient portal, Patient empowerment
Eligibility 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
Sites / Locations
- The Cleveland Clinic Foundation
Outcomes
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
Full Information
NCT ID
NCT00221455
First Posted
September 15, 2005
Last Updated
July 25, 2011
Sponsor
Robert Wood Johnson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00221455
Brief Title
The Potential of Technology to Improve Chronic Disease Management and Quality of Care
Official Title
The Potential of Technology to Improve Chronic Disease Management and Quality of Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Robert Wood Johnson Foundation
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Diabetes Mellitus, Chronic disease management, Patient portal, Patient empowerment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Patient diabetic self-management using the diabetic patient portal tools
Intervention Type
Behavioral
Intervention Name(s)
A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.
Primary Outcome Measure Information:
Title
Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.
Secondary Outcome Measure Information:
Title
Technology Adoption will be measured by tracking the patient usage of the various portal features
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Harris, MD, MBA
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Holly D Miller, MD, MBA
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Director
Facility Information:
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
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Links:
URL
https://mychart.clevelandclinic.org/default.asp
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