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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phone Counseling | Behavioral | Patient were contacted on a periodic basis via telephone to address there diabetes care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of CVD Patients With LDL Less Than 70 mg/dL. | 18 months | |
| Number of Patients With BP Less Than 130/80 mm Hg | Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period. | Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations | 18 months |
Inclusion Criteria:
Exclusion Criteria:We sought to maximize the generalizability of the study and therefore had only minimal exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond O Estacio, MD | Denver Health | Principal Investigator |
| Henry Fischer, MD | Denver Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health, Westside Clinic | Denver | Colorado | 80204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18606250 | Background | 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. |
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Patients were randomized directly from a registry.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis was per intention to treat. | Posted | Number | Participants | 18 months |
|
5 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Phone Counseling: Patient were contacted on a periodic basis via telephone to address there diabetes care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Estaico, MD | Denver Health | 303-860-9900 | Ray.Estacio@cpcmed.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| 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. |
|
|
| 18 months |
| Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study | Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines. | 18 months |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of CVD Patients With LDL Less Than 70 mg/dL. | Analysis was per intention to treat | Posted | Number | Participants | 18 months |
|
|
|
| Other Pre-specified | Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period. | Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations | Analysis per intention to treat | Posted | Number | Number of ED visits and hospitalizations | 18 months |
|
|
|
| Secondary | Number of Patients With BP Less Than 130/80 mm Hg | Number of patients meeting blood pressure goals as defined by the American Diabetes Association guidelines. | Analysis per intention to treat | Posted | Number | participants | 18 months |
|
|
|
| Secondary | Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study | Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines. | Posted | Number | Participants | 18 months |
|
|
|
| 0 |
| 381 |
| 0 |
| 381 |
| EG001 | 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. 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. | 0 | 381 | 0 | 381 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005159 | Health Care Facilities Workforce and Services |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |