Trial Outcomes & Findings for Nurse Telephone Management of Cholesterol in Diabetes (NCT NCT00950963)

NCT ID: NCT00950963

Last Updated: 2015-04-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 762 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2015-04-28

Participant Flow

Recruitment of patients began in September 2005 from one community clinic. Study nurses attempted to contact all patients in the control group at the beginning of the study only if they had not had an LDL level in the previous 12 month. An LDL level was obtained to be used as baseline.

Patients were randomized directly from a registry.

Participant milestones

Measure	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.	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.
Overall Study STARTED	381	381
Overall Study COMPLETED	352	357
Overall Study NOT COMPLETED	29	24

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	29	24

Baseline Characteristics

Nurse Telephone Management of Cholesterol in Diabetes

Baseline characteristics by cohort

Measure	Phone Counseling n=381 Participants The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.	Standard Care n=381 Participants 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.	Total n=762 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	252 Participants n=5 Participants	261 Participants n=7 Participants	513 Participants n=5 Participants
Age, Categorical >=65 years	129 Participants n=5 Participants	120 Participants n=7 Participants	249 Participants n=5 Participants
Age, Continuous	58.5 years STANDARD_DEVIATION 12.5 • n=5 Participants	58.3 years STANDARD_DEVIATION 12.1 • n=7 Participants	58.4 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	244 Participants n=5 Participants	218 Participants n=7 Participants	462 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants	163 Participants n=7 Participants	300 Participants n=5 Participants
Region of Enrollment United States	381 participants n=5 Participants	381 participants n=7 Participants	762 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Analysis was per intention to treat.

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

Outcome measures

Measure	Phone Counseling n=381 Participants The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.	Standard Care n=381 Participants 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.
Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL	223 Participants	178 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Analysis was per intention to treat

Outcome measures

Measure	Phone Counseling n=104 Participants The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.	Standard Care n=102 Participants 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.
Number of CVD Patients With LDL Less Than 70 mg/dL.	41 Participants	31 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Analysis per intention to treat

Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines.

Outcome measures

Measure	Phone Counseling n=381 Participants The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.	Standard Care n=381 Participants 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.
Number of Patients With BP Less Than 130/80 mm Hg	168 participants	191 participants

SECONDARY outcome

Timeframe: 18 months

Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines.

Outcome measures

Measure	Phone Counseling n=381 Participants The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.	Standard Care n=381 Participants 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.
Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study	62 Participants	59 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Population: Analysis per intention to treat

Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations

Outcome measures

Measure	Phone Counseling n=381 Participants The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.	Standard Care n=381 Participants 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.
Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period.	246 Number of ED visits and hospitalizations	360 Number of ED visits and hospitalizations

Adverse Events

Phone Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raymond Estaico, MD

Denver Health

Phone: 303-860-9900

Email: Ray.Estacio@cpcmed.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place