Clinical trial NCT00221455: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Chronic disease management
Patient portal
Patient empowerment
Lead sponsor: Robert Wood Johnson Foundation
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.
Secondary outcomes:
measure: Technology Adoption will be measured by tracking the patient usage of the various portal features
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Martin Harris, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Holly D Miller, MD, MBA
role: STUDY_DIRECTOR
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