Use of Online Personalized Health Record System to Promote Self-Management of Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Patient-Centered Online Disease Management Using a Personal Health Record System

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Online disease management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online disease management<br>The PAMFOnline-mediated Personalized Health Care Program, which couples a multidisciplinary diabetes care management team with an EHR-integrated Online Disease Management (ODM) system. | Behavioral: Online disease management<br>* The Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system.<br>* Other names: EMPOWER-D;|
| No Intervention: Usual care<br>Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C |  | Baseline, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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