Nurse Telephone Management of Cholesterol in Diabetes (NATCHOS)

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00950963
First received: January 12, 2009
Last updated: July 31, 2009
Last verified: July 2009
  Purpose

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 756 patients to either participate in a telephone-based, nurse-run outreach program (N=378) or to continue with usual care(N=378). 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. Impressions from care providers suggest that the current intervention has improved quality of care to these patients. 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.


Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
Behavioral: Phone Counseling
Other: Standard Clinical Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of CVD Patients With LDL Less Than 70 mg/dL. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Number of Patients With BP Less Than 130/80 mm Hg [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 762
Study Start Date: September 2005
Study Completion Date: June 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phone Counseling
The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
Behavioral: Phone Counseling
Patient were contacted on a periodic basis via telephone to address there diabetes care.
Other Names:
  • Telephone Intervention
  • Counseling
Active Comparator: Standard Care
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: Standard Clinical Care
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 Name: Standard Care

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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950963

Locations
United States, Colorado
Denver Health, Westside Clinic
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
American Diabetes Association
Investigators
Principal Investigator: Raymond O Estacio, MD Denver Health
Study Director: Henry Fischer, MD Denver Health
  More Information

Publications:
Responsible Party: Raymond Estacio, MD, Denver Health
ClinicalTrials.gov Identifier: NCT00950963     History of Changes
Other Study ID Numbers: 05-509
Study First Received: January 12, 2009
Results First Received: January 12, 2009
Last Updated: July 31, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
Diabetes, Nurse phone intervention, lipid control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014