Type II Diabetes Clinical Trial
Official title:
Randomized Trial of Health Promotion 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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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