Type 2 Diabetes Clinical Trial
— NATCHOSOfficial title:
Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics
The current project is evaluating the effect of a nurse-administered phone care in diabetes to improve access to care and healthcare delivery. The setting is a federally qualified community health center serving over 1600 diabetic patients, 80% of whom are Latino. Using our diabetes registry, we have randomly assigned 762 patients to either participate in a telephone-based, nurse-run outreach program (N=381) or to continue with usual care(N=381). Three of our registered nurses learned algorithms addressing management of cholesterol, blood pressure, kidney disease, aspirin use, eye screening, and pneumovax and influenza vaccines. The program began recruitment in September 2005 and has finished follow up in May 2007. The program initially focused only on cholesterol management utilizing national guidelines and algorithms on patients with elevated cholesterol (LDL) levels but has expanded to include glycemic and blood pressure control. We found that Registered Nurses were able and willing to provide telephone care to diabetic patients according to moderately complex algorithms and to track patient data electronically with overall job satisfaction. Overall, the nurses have expressed enthusiasm but have also experience frustrations with maintaining contact and improving motivation in patients. The impact of this program on diabetes outcomes and its cost-effectiveness is currently being analyzed with the goal of implementing this program in our institution.
Status | Completed |
Enrollment | 762 |
Est. completion date | June 2008 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 17 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients included in Denver Health diabetes registry. 2. Type I and Type II diabetic patients 3. Age >17 years old 4. Actively utilizing Westside Clinic for their primary care (at least two visits in the past year) 5. Speak either English or Spanish. Exclusion Criteria:We sought to maximize the generalizability of the study and therefore had only minimal exclusion criteria: 1. Pregnant or lactating women 2. Patients with end-stage renal disease (creatinine > 3.0 mg/dl) 3. Patients with a co-morbid illness with life expectancy less than 12 months, (e.g. terminal cancer or Child's Class C hepatic cirrhosis). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Denver Health, Westside Clinic | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
Denver Health and Hospital Authority | American Diabetes Association |
United States,
Fischer H, Mackenzie T, McCullen K, Everhart R, Estacio RO. Design of a nurse-run, telephone-based intervention to improve lipids in diabetics. Contemp Clin Trials. 2008 Sep;29(5):809-16. doi: 10.1016/j.cct.2008.05.011. Epub 2008 Jun 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period. | Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations | 18 months | No |
Primary | Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL | Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study | 18 months | No |
Secondary | Number of CVD Patients With LDL Less Than 70 mg/dL. | 18 months | No | |
Secondary | Number of Patients With BP Less Than 130/80 mm Hg | Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines. | 18 months | No |
Secondary | Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study | Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines. | 18 months | No |
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