Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
Diabetes, Nurse phone intervention, lipid control
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.
Interventions
BEHAVIORALPhone Counseling
Patient were contacted on a periodic basis via telephone to address there diabetes 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.
Sponsors
American Diabetes Association
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients included in Denver Health diabetes registry. 2. Type I and Type II diabetic patients 3. Age \>17 years old 4. Actively utilizing Westside Clinic for their primary care (at least two visits in the past year) 5. Speak either English or Spanish.
Exclusion criteria
We sought to maximize the generalizability of the study and therefore had only minimal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | 18 months | Number of patients with Hgb A1c as recommended by the American Diabetes Association guidelines. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period. | 18 months | Evaluate the effect of the intervention on healthcare utilization as defined by ED visits and hospitalizations |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Patients were randomized directly from a registry.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 381 |
| 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. | 381 |
| Total | 762 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 29 | 24 |
Baseline characteristics
| Characteristic | Standard Care | Phone Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 120 Participants | 129 Participants | 249 Participants |
| Age, Categorical Between 18 and 65 years | 261 Participants | 252 Participants | 513 Participants |
| Age, Continuous | 58.3 years STANDARD_DEVIATION 12.1 | 58.5 years STANDARD_DEVIATION 12.5 | 58.4 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 381 participants | 381 participants | 762 participants |
| Sex: Female, Male Female | 218 Participants | 244 Participants | 462 Participants |
| Sex: Female, Male Male | 163 Participants | 137 Participants | 300 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 381 | 0 / 381 |
| serious Total, serious adverse events | 0 / 381 | 0 / 381 |
Outcome results
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
Time frame: 18 months
Population: Analysis was per intention to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phone Counseling | Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL | 223 Participants |
| Standard Care | Number of Patients With a Low Density Lipid (LDL) Value Less Than 100 mg/dL | 178 Participants |
Secondary
Number of CVD Patients With LDL Less Than 70 mg/dL.
Time frame: 18 months
Population: Analysis was per intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phone Counseling | Number of CVD Patients With LDL Less Than 70 mg/dL. | 41 Participants |
| Standard Care | Number of CVD Patients With LDL Less Than 70 mg/dL. | 31 Participants |
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.
Time frame: 18 months
Population: Analysis per intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phone Counseling | Number of Patients With BP Less Than 130/80 mm Hg | 168 participants |
| Standard Care | Number of Patients With BP Less Than 130/80 mm Hg | 191 participants |
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.
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phone Counseling | Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study | 62 Participants |
| Standard Care | Number of Patients With Hgb A1c Less Than 7 Percent at the End of the Study | 59 Participants |
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
Time frame: 18 months
Population: Analysis per intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phone Counseling | Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period. | 246 Number of ED visits and hospitalizations |
| Standard Care | Number of Total Emergency Department (ED) Visits and Hospital Admissions During the Follow up Period. | 360 Number of ED visits and hospitalizations |