Nurse Telephone Management of Cholesterol in Diabetes (NATCHOS)

• ClinicalTrials.gov Identifier: NCT00950963
• Recruitment Status: Completed
• First Posted: August 3, 2009
• Results First Posted: August 3, 2009
• Last Update Posted: April 28, 2015
• Sponsor: Denver Health and Hospital Authority
• Collaborator: American Diabetes Association
• Information provided by: Denver Health and Hospital Authority

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes; Type 2 Diabetes	Behavioral: Phone Counseling; Other: Standard Clinical Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 762 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics
• Study Start Date: September 2005
• Actual Primary Completion Date: May 2007
• Actual Study Completion Date: June 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 17 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: 05-509
• First Posted: August 3, 2009
• Results First Posted: August 3, 2009
• Last Update Posted: April 28, 2015
• Last Verified: April 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