Outreach for Diabetes Cure
Primary Purpose
Type II Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health promotion outreach
Sponsored by

About this trial
This is an interventional health services research trial for Type II Diabetes focused on measuring Type II Diabetes, Diabetes
Eligibility Criteria
Inclusion Criteria:
- diagnosis of type II diabetes
- visit to University of Colorado Hospital in primary care clinic in last 18 months
Sites / Locations
- University of Colorado Hopspital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Arm 1-Health Promotoin Outreach
Arm Description
Patients continue to receive usual diabetes care without outreach by health promotions staff.
Active outreach by health promotion staff to send diabetes report card and schedule services including laboratory testing and visits.
Outcomes
Primary Outcome Measures
Composite Measure of Guideline Concordance
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
Secondary Outcome Measures
Individual measures of guideline concordance
Individual measures of guideline concordance. Assessment of the outcome measures of the composite measures separately.
Full Information
NCT ID
NCT01384045
First Posted
June 27, 2011
Last Updated
December 17, 2012
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT01384045
Brief Title
Outreach for Diabetes Cure
Official Title
Randomized Trial of Health Promotion Outreach for Diabetes Cure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
Ten percent of all people over the age of 20, and 21% of all people over the age of 60, have diabetes. Diabetes is the sixth leading cause of death, and is one of the most prominent causes of heart disease, stroke, blindness, nephropathy, and neuropathy. Total health care expenditures for diabetes and its complications are enormous, amounting to more than $132 billion in direct and indirect costs in 2002. Nationally, substantial percentages of diabetic patients are not meeting ADA, Health Plan Employer Data and Information Set, (HEDIS), and Physician Quality Reporting Initiative (PQRI) guidelines for care that are intended to reduce morbidity and mortality associated with this disease. In order to improve these statistics, novel ways of delivering primary and secondary preventive diabetes care are needed. The growing use of electronic medical record systems and the ability to extract clinically-relevant information from administrative data sets offer powerful opportunities to identify patients who are "falling through the cracks," reach out to them proactively where they live, and render medical services and education in ways that maximize convenience and minimize barriers associated with sporadic and time-limited clinic visits.
The delivery of preventive and chronic disease services is sub-optimal in outpatient settings. Rates of guideline concordance for diabetes care within University of Colorado Hospital (UCH) are in most instances modestly better than national averages, yet there remains tremendous room for improvement. Clinic visits are often too brief for medical providers to review and arrange for all recommended care. Providers are frequently hampered by poorly-organized clinical data and a lack of automated reminders. Finally, many patients do not know about recommendations for care and prefer to focus on acute concerns during clinic visits.
Although decision support in the medical provider's office can improve guideline-based care for chronic illness, it does not improve outcomes among patients who fail to make clinic appointments or who make appointments for reasons unrelated to the illness. The investigators developed a health promotion outreach system (HPOS) to overcome many of these barriers. The purpose of HPOS is to increase access to and enhance the delivery of guideline-based care by communicating with patients outside of clinical settings.
Our diabetes-specific HPOS intervention incorporates the following key elements: (1) electronic queries of administrative claims to identify patients who are not up-to-date with recommended diabetes services; (2) mail and telephone outreach to alert patients about recommendations for care and facilitate the direct scheduling of primary care provider (PCP) visits, laboratory testing several days before PCP visits, and ophthalmology appointments; and (3) advance PCP notification regarding the intended diabetes focus of appointments arranged through the outreach process. The purpose of this study is to assess whether this intervention improves guideline concordance for LDL cholesterol, hemoglobin A1c, blood pressure, retinal examinations, and aspirin therapy as well as clinical attention to diabetes during primary care visits.
The investigators believe our intervention will reduce several barriers associated with usual care. First, the investigators reach out proactively to inform patients about recommendations for care instead of waiting for them to make appointments haphazardly and often for reasons unrelated to diabetes. The investigators make daytime and evening telephone calls to patients, many of whom are undoubtedly busy and forgetful, when they do not themselves call in response to letters that summarize personalized recommendations. The investigators schedule all laboratories and PCP visits at a single point in time, over the phone, and then send reminder postcards that summarize this information. Rather than completing laboratory testing during PCP visits and then requiring PCPs to convey recommendations for care several days later, the investigators schedule laboratories ahead of time whenever possible so that timely information will be available help guide clinical decision-making at the point of care. Finally, the investigators notify patients and PCPs in advance about the diabetes-specific purpose of scheduled appointments and specific areas needing clinical attention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes
Keywords
Type II Diabetes, Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients continue to receive usual diabetes care without outreach by health promotions staff.
Arm Title
Arm 1-Health Promotoin Outreach
Arm Type
Experimental
Arm Description
Active outreach by health promotion staff to send diabetes report card and schedule services including laboratory testing and visits.
Intervention Type
Other
Intervention Name(s)
Health promotion outreach
Intervention Description
Calling patients who are due for diabetes related services, sending them an interventional letter and assisting them in getting over due serves.
Primary Outcome Measure Information:
Title
Composite Measure of Guideline Concordance
Description
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
Time Frame
After 1 year
Secondary Outcome Measure Information:
Title
Individual measures of guideline concordance
Description
Individual measures of guideline concordance. Assessment of the outcome measures of the composite measures separately.
Time Frame
After 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of type II diabetes
visit to University of Colorado Hospital in primary care clinic in last 18 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Ross, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Razzaghi Mitra, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lobo Ingrid, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hopspital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
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Outreach for Diabetes Cure
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