- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00950963
Nurse Telephone Management of Cholesterol in Diabetes (NATCHOS)
April 23, 2015 updated by: Denver Health and Hospital Authority
Nurse-run, Telephone-based Intervention to Improve Lipids in Diabetics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
762
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80204
- Denver Health, Westside Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Patient were contacted on a periodic basis via telephone to address there diabetes care.
Other Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL
Time Frame: 18 months
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Number of patients with and without cardiovascular disease (CVD) with LDL value less than 100 mg/dL at the end of the study
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18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of CVD Patients With LDL Less Than 70 mg/dL.
Time Frame: 18 months
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18 months
|
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Number of Patients With BP Less Than 130/80 mm Hg
Time Frame: 18 months
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Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.
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18 months
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Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study
Time Frame: 18 months
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Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.
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18 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.
Time Frame: 18 months
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Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations
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18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Raymond O Estacio, MD, Denver Health
- Study Director: Henry Fischer, MD, Denver Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
January 12, 2009
First Submitted That Met QC Criteria
June 22, 2009
First Posted (Estimate)
August 3, 2009
Study Record Updates
Last Update Posted (Estimate)
April 28, 2015
Last Update Submitted That Met QC Criteria
April 23, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-509
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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