Nurse Telephone Management of Cholesterol in Diabetes - Full Text View

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 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.

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


Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Cholesterol

U.S. FDA Resources

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

Secondary Outcome Measures:

Number of CVD Patients With LDL Less Than 70 mg/dL. [ Time Frame: 18 months ]
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.
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 Outcome Measures:

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


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

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 (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

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:

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.


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:	April 23, 2015

Keywords provided by Denver Health and Hospital Authority:


Diabetes, Nurse phone intervention, lipid control

Additional relevant MeSH terms:


Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on May 25, 2017

Nurse Telephone Management of Cholesterol in Diabetes (NATCHOS)