Outcomes and Cost Consequences of Using an Internet Co-Management Module to Improve the Quality of Type 1 Diabetes Care
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The researchers will conduct a 12-month randomized controlled trial comparing usual care
      versus chronic disease management using the Internet among patients with type 1 diabetes
      receiving care in the Diabetes Care Center at the University of Washington.
    

Detailed description: 
      We will conduct a 12-month randomized controlled trial comparing usual care versus chronic
      disease management using the Internet among patients with type 1 diabetes on multiple daily
      injections with insulin glargine and rapid-acting analogs. Specifically, the objectives of
      the study are to:

        1. Evaluate the difference in glycemic control (HbA1c) between intervention and control,

        2. Evaluate the difference in resource utilization and costs of care between intervention
           and control, and

        3. Evaluate the difference in satisfaction with care between intervention and control.

      A total of 80-85 subjects will be recruited from patients receiving care in the Diabetes Care
      Center (DCC) at the University of Washington in Seattle. As part of a pretest-posttest
      experimental design, intervention-group subjects will be trained in the use of an existing
      diabetes disease-management module comprising six related Web sites that are accessed from
      home via links displayed within the University's "MyUW" Internet portal. These sites allow
      patients to:

        1. View their entire electronic medical record including clinical reminders, the same
           record used by providers,

        2. Upload blood glucose readings stored in a digital meter,

        3. Manually enter medication, nutrition, and exercise data into an online daily diary,

        4. Communicate with providers regarding treatment recommendations or other questions using
           a clinical e-mail service,

        5. Obtain additional information from a traditional education site whose content and links
           were sanctioned by the Medical Director of the DCC, and

        6. Employ a second education site to collaboratively generate action plans intended to
           enhance self-efficacy.

      In addition to login and password protection, access to confidential information from home
      requires the use of secondary authentication (SecureID). All clinical and other data can be
      viewed by patients and providers in online trended displays that will be used by a nurse
      practitioner to review cases no less than weekly. As the control group, subjects receiving
      usual care will not have access to the diabetes module and related case-management services
      being evaluated.

      The primary clinical outcome for the study is the between group differences in glycemic
      control using HbA1c as the metric. A co-primary outcome is all direct medical care
      utilization. Satisfaction with diabetes care, employing both a quantitative survey (Patient
      Assessment of Chronic Illness Care) and semi-structured interviews performed on a 20%
      purposive sub-sample of intervention patients, is a secondary outcome measure.
    

Intervention name(s): Internet co-management module
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Diabetes; Health Education; Information Technology; Disease Management; Internet; Patient Education