Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Diabetes |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/14/2018 |
Start Date: | April 1, 2016 |
End Date: | January 22, 2018 |
Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients
There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor
control on graft survival disparities in Black transplant recipients. Studies in the general
population indicate that CVD risk factor control is poor in Black patients, leading to higher
rates of renal failure and CV events. However, with the exception of hypertension, there is
paucity in data demonstrating similar results within transplant recipients. Recent analyses
conducted within our transplant program, indicate that CVD risk factors, especially diabetes,
are poorly controlled in Black recipients, which likely impacts graft loss. Since these data
were collected in a retrospective manner, larger analyses are needed to validate these
exploratory findings.
This pilot study is to:
1. Determine if the study is feasible, as measured by the proportions of enrolled to
approached and completed to enrolled.
2. Measure and compare, at baseline versus the end of the intervention, the medication
safety events, including the number of medication errors, medication non-adherence and
medication side effects, in patients enrolled in the study
3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor
control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the
study
4. Measure and compare, at baseline versus the end of the intervention, patient reported
survey results, in patients enrolled in the study
5. Determine if the impact of the intervention is more pronounced in Black recipients, as
compared to non-Black recipients
control on graft survival disparities in Black transplant recipients. Studies in the general
population indicate that CVD risk factor control is poor in Black patients, leading to higher
rates of renal failure and CV events. However, with the exception of hypertension, there is
paucity in data demonstrating similar results within transplant recipients. Recent analyses
conducted within our transplant program, indicate that CVD risk factors, especially diabetes,
are poorly controlled in Black recipients, which likely impacts graft loss. Since these data
were collected in a retrospective manner, larger analyses are needed to validate these
exploratory findings.
This pilot study is to:
1. Determine if the study is feasible, as measured by the proportions of enrolled to
approached and completed to enrolled.
2. Measure and compare, at baseline versus the end of the intervention, the medication
safety events, including the number of medication errors, medication non-adherence and
medication side effects, in patients enrolled in the study
3. Measure and compare, at baseline versus the end of the intervention, CVD risk factor
control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the
study
4. Measure and compare, at baseline versus the end of the intervention, patient reported
survey results, in patients enrolled in the study
5. Determine if the impact of the intervention is more pronounced in Black recipients, as
compared to non-Black recipients
Inclusion Criteria:
1. At least 18 years of age and able to give informed consent.
2. Received a first or repeat cadaveric or living donor renal transplant.
3. Patient has adequate graft function, defined as an estimated glomerular filtration
rate (GFR) of at least 20 mL/min, using the 4-variable Modification of Diet in Renal
Disease (MDRD) equation.
4. Patient is at least one year post transplant.
5. Patient has documented hypertension, defined as a sitting blood pressure of at least
140/90 mmHg or receiving any anti-hypertensive therapy.
6. Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5%
or receiving any anti-glycemic medications.
7. Willing to comply with all study visits.
Exclusion Criteria:
1. Biopsy proven acute rejection episode that occurred within the past month.
2. Patients who have received an organ transplant other than a kidney.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
Click here to add this to my saved trials