Nurse Telephone Management of Cholesterol in Diabetes (NATCHOS)

Tracking Information
First Submitted Date ICMJE	January 12, 2009
First Posted Date ICMJE	August 3, 2009
Results First Submitted Date	January 12, 2009
Results First Posted Date	August 3, 2009
Last Update Posted Date	April 28, 2015
Study Start Date ICMJE	September 2005
Actual Primary Completion Date	May 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 23, 2015)	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; (submitted: June 22, 2009)	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; (submitted: April 23, 2015)	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; (submitted: June 22, 2009)	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; (submitted: April 23, 2015)	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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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
Actual Enrollment ICMJE; (submitted: June 22, 2009)	762
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2008
Actual 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, Older Adult)
Accepts Healthy Volunteers	No
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	No
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