Patient-Centered Online Disease Management Using a Personal Health Record System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Palo Alto Medical Foundation
- Enrollment
- 415
- Locations
- 9
- Primary Endpoint
- Hemoglobin A1C
Study Overview
Brief Summary
Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>= 18 years of age
- •Have a designated Palo Alto Medical Foundation Primary Care Provider (PCP)
- •Seen in primary or specialty care at the Palo Alto Division at least once in the preceding 24 months
- •Diagnosis of diabetes
- •Baseline A1C >= 7.5%
Exclusion Criteria
- •Initial diagnosis of diabetes within the last 12 months
- •Diagnosis of Type 1 diabetes
- •Inability to speak and read in English
- •Lack of regular access to a computer with Internet and email capabilities
- •Unwilling to perform any self-monitoring at home, including blood glucose and blood pressure%
- •Pregnant, planning to become pregnant, or lactating
- •Currently enrolled in a care management program at Palo Alto Medical Foundation or elsewhere
- •PCP determination that the study is inappropriate or unsafe for the patient
- •Investigator discretion for clinical safety or protocol adherence reasons
Outcomes
Primary Outcomes
Hemoglobin A1C
Time Frame: Baseline, 6 months and 12 months
Secondary Outcomes
- Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)(Baseline, 6 months and 12 months)
- Cardiovascular risk (e.g., blood pressure and lipids)(Baseline, 6 months and 12 months)
- Patient experience and satisfaction (e.g., relevant CAHPS measures)(Baseline and 12 months)
- Patient psychosocial well-being (e.g., diabetes-related emotional distress)(Baseline, 6 months and 12 months)
- Processes of care (e.g., frequency of lab testing)(Baseline, 6 months and 12 months)
Investigators
Paul Tang
Vice President
Palo Alto Medical Foundation