Outreach for Diabetes Cure
Using a socioeconomic, race/ethnic, and gender-diverse sample of patients who receive diabetes care from a University of Colorado Hospital (UCH) primary care provider (PCP), carry out a randomized-controlled trial of usual care versus an outreach intervention designed to increase guideline concordance with American Diabetes Association (ADA) recommendations for blood pressure, Low-density lipoprotein (LDL), and glycosylated hemoglobin (A1c) goals, referrals for retinal exams, and aspirin therapy.Primary hypotheses: The proportion of patients meeting goal will be 10% higher in the intervention compared with control group in the following domains: 1. LDL<100 mg/dL; 2. A1c<7.0%; and 3. Systolic blood pressure<130 mm Hg or diastolic blood pressure<80 mm Hg.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Randomized Trial of Health Promotion Outreach for Diabetes Cure|
- Composite Measure of Guideline Concordance [ Time Frame: After 1 year ] [ Designated as safety issue: No ]
Composite measure of guideline concordance with 1 point for concordance with each of the following:
- hemoglobin a1c less than 7%
- ldl cholesterol less than 100 mgs per decaliter
- urinary micro albumin measured in preceding 12 months
- both systolic bp less than 130 mms mercury & diastolic bp less than 80 mms mercury
- Individual measures of guideline concordance [ Time Frame: After 1 year ] [ Designated as safety issue: No ]Individual measures of guideline concordance. Assessment of the outcome measures of the composite measures separately.
|Study Start Date:||February 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care
Patients continue to receive usual diabetes care without outreach by health promotions staff.
Experimental: Arm 1-Health Promotoin Outreach
Active outreach by health promotion staff to send diabetes report card and schedule services including laboratory testing and visits.
Other: Health promotion outreach
Calling patients who are due for diabetes related services, sending them an interventional letter and assisting them in getting over due serves.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01384045
|United States, Colorado|
|University of Colorado Hopspital|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Steven Ross, MD||University of Colorado, Denver|
|Principal Investigator:||Razzaghi Mitra, MD||University of Colorado, Denver|
|Principal Investigator:||Lobo Ingrid, MD||University of Colorado, Denver|