Nurse Telephone Management of Cholesterol in Diabetes

NCT00950963 | Completed Results

• 1 other identifier: 05-509
• Study Type: interventional
• Target: 762
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Diabetes, Nurse phone intervention, lipid control

Outcome Measures

Primary Outcomes (1)

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

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

  18 months

Secondary Outcomes (3)

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

  18 months

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

  18 months

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

  18 months

Other Outcomes (1)

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

  18 months

Study Arms (2)

Phone Counseling

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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

Interventions

Phone Counseling BEHAVIORAL

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

Also known as: Telephone Intervention, Counseling

Phone 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.

Also known as: Standard Care

Standard Care

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• American Diabetes Association: collaborator

Study Sites (1)

Denver Health, Westside Clinic

Denver, Colorado, 80204, United States

Location

Related Publications (1)

• 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.

  PMID: 18606250 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Counseling; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Raymond Estaico, MD
• Organization: Denver Health

Ray.Estacio@cpcmed.org

303-860-9900

Study Officials

• Raymond O Estacio, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

• Henry Fischer, MD

  Denver Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2009
• First Posted: August 3, 2009
• Study Start: September 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2008
• Last Updated: April 28, 2015
• Results First Posted: August 3, 2009

Record last verified: 2015-04

Locations

US (1)