Screen-and-treat Program for Chronic Kidney Disease- High Risk Persons
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 1/19/2019 |
Start Date: | September 2015 |
End Date: | December 2018 |
Can a Targeted Screen-and-treat Program for Chronic Kidney Disease Improve Blood Pressure (BP) Management Among Persons at High Risk for Complications ?
The overall hypothesis of this trial is that screening for chronic kidney disease, followed
by education or treatment program will improve blood pressure control among hypertensive
non-diabetic persons.
by education or treatment program will improve blood pressure control among hypertensive
non-diabetic persons.
Aim 1. To evaluate whether an automated CKD CDSS achieves lower BP levels, higher rates of BP
control and appropriate use of ACE/ARB compared with usual care, among persons with eGFRcreat
< 60 ml/min/1.73m^2 in primary care.
Hypothesis 1a. The CKD CDSS will result in improved BP levels and BP control, compared to
usual care.
Hypothesis 1b. Within the CKD CDSS group, utilization of ACE/ARB among persons with
albuminuria will increase during follow-up.
Aim 2. To evaluate the acceptability and feasibility of implementing a CDSS for improving
disease awareness and staging by primary care providers, compared with usual care, among
persons with eGFRcreat < 60 ml/min/1.73m^2.
Hypothesis 2a. The CKD CDSS will result in increased physician CKD awareness, staging and
appropriate testing for albuminuria, cystatin C and CKD complications (anemia,
hyperphosphatemia, hyperparathyroidisim) in persons with reduced eGFRcreat.
Hypothesis 2b. The CKD CDSS will require low expenditures and will be readily accepted by
PCPs and patients.
Aim 3. To evaluate whether a CDSS PLUS pharmacist-led CKD management program can improve BP
levels and patient disease knowledge in persons with higher-risk CKD, compared to CDSS alone.
Hypothesis 3a. The pharmacist-led CKD management strategy will result in lower BP levels and
higher rates of appropriate use of ACE/ARB, compared to the CDSS alone.
Hypothesis 3b. The pharmacist-led BP management program will be acceptable to PCPs, and it
will result in higher levels of patient CKD and NSAID-avoidance knowledge compared with CDSS
alone.
control and appropriate use of ACE/ARB compared with usual care, among persons with eGFRcreat
< 60 ml/min/1.73m^2 in primary care.
Hypothesis 1a. The CKD CDSS will result in improved BP levels and BP control, compared to
usual care.
Hypothesis 1b. Within the CKD CDSS group, utilization of ACE/ARB among persons with
albuminuria will increase during follow-up.
Aim 2. To evaluate the acceptability and feasibility of implementing a CDSS for improving
disease awareness and staging by primary care providers, compared with usual care, among
persons with eGFRcreat < 60 ml/min/1.73m^2.
Hypothesis 2a. The CKD CDSS will result in increased physician CKD awareness, staging and
appropriate testing for albuminuria, cystatin C and CKD complications (anemia,
hyperphosphatemia, hyperparathyroidisim) in persons with reduced eGFRcreat.
Hypothesis 2b. The CKD CDSS will require low expenditures and will be readily accepted by
PCPs and patients.
Aim 3. To evaluate whether a CDSS PLUS pharmacist-led CKD management program can improve BP
levels and patient disease knowledge in persons with higher-risk CKD, compared to CDSS alone.
Hypothesis 3a. The pharmacist-led CKD management strategy will result in lower BP levels and
higher rates of appropriate use of ACE/ARB, compared to the CDSS alone.
Hypothesis 3b. The pharmacist-led BP management program will be acceptable to PCPs, and it
will result in higher levels of patient CKD and NSAID-avoidance knowledge compared with CDSS
alone.
Inclusion Criteria:
The entire primary care medical practice at SFVAMC will be considered. Randomization will
occur at the team (nurse) level. Within each team, individual patients will be considered
eligible for chronic kidney disease screening by this protocol and inclusion in our trial
if they have hypertension without concomitant diabetes, and no prior recorded diagnosis of
chronic kidney disease. Hypertension will be defined as systolic blood pressure >140 or
diastolic blood pressure >90 mmHg at more than two encounters (any encounter) within the
previous 3 years or a documented diagnosis of hypertension (listed in problem list or ICD-9
code). Diagnosed chronic kidney disease will be defined as a documentation of chronic
kidney disease in the problem list or ICD-9 code or on-going nephrology follow up. We
define diagnosed chronic kidney disease without consideration of estimated glomerular
filtration rate by creatinine or albumin-creatinine-ratio in the laboratory section of the
medical record, since work from our group and others has shown that awareness and
recognition of chronic kidney disease is extremely low, even among persons with documented
reduced estimated glomerular filtration rate or albuminuria. Persons will be required to
have seen their physician at least one time within the past 18 months.
Exclusion Criteria:
Kidney transplant recipients, pregnant women, and individuals with an estimated glomerular
filtration rate <15 ml/min/1.73 m2 will be excluded from this study as they likely need
specialty care for uncontrolled hypertension. Persons aged >80 will be excluded because
data on aggressive blood pressure lowering in this population are less clear and adverse
effects associated with aggressive blood pressure control have been well documented. We
will exclude persons with New York Heart Association class III or IV heart failure, known
ejection fraction <25%, or documented allergy to Angiotensin-Converting Enzyme/Angiotensin
II Receptor Blockers. Other exclusion criteria relate to the required ability to
communicate with providers and provide informed consent: prevalent dementia, impaired
cognition or severe mental illness; expected life expectancy <6 months; severe visual
impairment in the absence of an available caretaker who can read.
We found this trial at
1
site
San Francisco, California 94121
Principal Investigator: Carmen Peralta, MD, MAS
Phone: 415-221-4810
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