Diabetes Mellitus
Conditions
Keywords
Diabetes, Blood Glucose Self-Monitoring, Home Blood Glucose Monitoring, Internet, Personal Health Record (PHR), Health Information Technology (HIT), Care management, Disease Management, Diabetes self-management, Consumer Health Information, Medical Records Systems, Computerized, Computerized Medical Records System, Automated Medical Records System, Electronic Health Record (EHR), Remote patient monitoring
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.
Interventions
BEHAVIORALOnline disease management
The Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Sutter Health
Palo Alto Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C | Baseline, 6 months and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise) | Baseline, 6 months and 12 months |
| Processes of care (e.g., frequency of lab testing) | 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 |
Countries
United States
Outcome results
None listed