Clinical trial NCT00950963: Nurse Telephone Management of Cholesterol in Diabetes
Official title: Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Diabetes, Nurse phone intervention, lipid control
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2009-08-03
Enrollment: 762
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: This randomized, controlled trial tested the effectiveness of a nurse-run, telephone-based intervention to improve lipid control in patients with diabetes. Our patient population is predominantly low-income and Latino. Using our diabetes registry, we randomly assigned 381 patients to continue with their usual care and 381 to participate in our nurse run program. Three registered nurses learned algorithms for diabetes care. These algorithms address management of lipids, glycemic control, blood pressure, nephropathy, aspirin use, eye screening, pneumovax and influenza vaccines, obesity, and cigarette smoking. The nurses were also trained in motivational interviewing techniques and facilitation of patient self-management. The primary goal was to improve lipid control in our diabetic population. Secondary outcomes address blood pressure control, glycemic control, renal function, and medication adherence. In addition, a cost-effective analysis is being performed.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL
timeFrame: 18 months
Secondary outcomes:
measure: Number of CVD Patients With LDL Less Than 70 mg/dL.
timeFrame: 18 months
measure: Number of Patients With BP Less Than 130/80 mm Hg
timeFrame: 18 months
measure: Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study
timeFrame: 18 months
Other outcomes:
measure: Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.
timeFrame: 18 months
Locations:
city: Denver
country: United States
facility: Denver Health, Westside Clinic
state: Colorado
Study officials:
affiliation: Denver Health
name: Raymond O Estacio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver Health
name: Henry Fischer, MD
role: STUDY_DIRECTOR
References:
citation: 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.