Use of Online Personalized Health Record System to Promote Self-Management of Diabetes (EMPOWER-D)

Sutter Health

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: Online disease management

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00542204

1R18HS017179-01

Details and patient eligibility

About

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.

Enrollment: 415 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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415 participants in 2 patient groups

Online disease management

Experimental group

Description:

The PAMFOnline-mediated Personalized Health Care Program, which couples a multidisciplinary diabetes care management team with an EHR-integrated Online Disease Management (ODM) system.

Treatment:

Behavioral: Online disease management

Usual care

No Intervention group

Description:

Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management.