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: April 23, 2015

Last verified: April 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2009

Last Updated Date

April 23, 2015

Start Date ^ICMJE

September 2005

Primary Completion Date

May 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL [ Time Frame: 18 months ]

Change History

Complete list of historical versions of study NCT00950963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Number of CVD Patients With LDL Less Than 70 mg/dL. [ Time Frame: 18 months ]
Number With BP Less Than 130/80 mm Hg [ Time Frame: 18 months ]
Number With Hgb A1c Less Than 7 Percent at the End of the Study [ Time Frame: 18 months ]

Current Other Outcome Measures ^ICMJE

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

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nurse Telephone Management of Cholesterol in Diabetes

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Type 1 Diabetes
Type 2 Diabetes

Intervention ^ICMJE

Behavioral: Phone Counseling
Patient were contacted on a periodic basis via telephone to address there diabetes care.
Other Names:
- Telephone Intervention
- Counseling
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

Study Arms

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.

Intervention: Behavioral: Phone 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.

Intervention: Other: Standard Clinical Care

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

762

Completion Date

June 2008

Primary Completion Date

May 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Sex/Gender

Sexes Eligible for Study:

All

Ages

17 Years and older (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00950963

Other Study ID Numbers ^ICMJE

05-509

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Raymond Estacio, MD, Denver Health

Study Sponsor ^ICMJE

Denver Health and Hospital Authority

Collaborators ^ICMJE

American Diabetes Association

Investigators ^ICMJE

Principal Investigator:	Raymond O Estacio, MD	Denver Health
Study Director:	Henry Fischer, MD	Denver Health

PRS Account

Denver Health and Hospital Authority

Verification Date

April 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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