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Completed

NCT Number: NCT00950963

Nurse Telephone Management of Cholesterol in Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health, Westside Clinic

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients included in Denver Health diabetes registry.
  • Type I and Type II diabetic patients
  • Age >17 years old
  • Actively utilizing Westside Clinic for their primary care (at least two visits in the past year)
  • Speak either English or Spanish.

Exclusion criteria

We sought to maximize the generalizability of the study and therefore had only minimal exclusion criteria:

  • Pregnant or lactating women
  • Patients with end-stage renal disease (creatinine > 3.0 mg/dl)
  • Patients with a co-morbid illness with life expectancy less than 12 months, (e.g. terminal cancer or Child's Class C hepatic cirrhosis).

Treatment and study plan

Phone counseling

Behavioral

Patient were contacted on a periodic basis via telephone to address there diabetes care.

Other names: Telephone Intervention, Counseling

Standard clinical care

Other

Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.

Other names: Standard Care

Primary outcomes

  1. Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL

    Time frame: 18 months

    Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study

Secondary outcomes

  1. Number of CVD Patients With LDL Less Than 70 mg/dL.

    Time frame: 18 months

  2. Number of Patients With BP Less Than 130/80 mm Hg

    Time frame: 18 months

    Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.

  3. Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study

    Time frame: 18 months

    Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.

Other outcomes

  1. Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.

    Time frame: 18 months

    Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics

Acronym: NATCHOS

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Aug 3, 2009
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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