Integrating Risk-based Care for Patients With CKD
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|ClinicalTrials.gov Identifier: NCT03365063|
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : October 11, 2018
Chronic kidney disease (CKD) and its end stage of kidney failure are major public health problems in Canada and worldwide. In the primary care setting, accurate prediction of the risk of kidney failure in patients with CKD can improve patient provider communication, assist in appropriate nephrology referral, improve dialysis treatment planning, and identify patients who are most likely to benefit from intervention. To aid in accurately predicting the risk of kidney failure requiring dialysis in patients with CKD, the primary investigator has developed and validated the kidney failure risk equation (KFRE), which is increasingly used in nephrology practices across Canada and the United States.
In this current study, a cluster randomized controlled trial (RCT) will be done in collaboration with the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). Primary care clinics that can integrate the KFRE into their electronic medical records will be randomized to receive the intervention (patients and providers receive individualized information explaining kidney failure risk, as well as risk-based criteria for referral, alongside usual care) versus usual care alone (no information on personalized risk and no risk-based referral). In both groups, the investigators will assess management of patients at high risk of kidney failure (patient), timing of referral for patients at high risk of kidney failure (health system), cost of CKD care (health system), CKD-specific health literacy (patient), trust in physician care (patient), and satisfaction with risk prediction tools (provider).
The objective of this research study is to develop, implement, and evaluate tools to guide the care of patients with CKD in the community, including appropriate referral using a risk-based approach. Specifically, this study will address the question: "Does providing patients (and their physicians) with information about their risk of kidney failure improve quality of care, health literacy, and trust in the care they are receiving?"
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Other: Active Knowledge Translation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Integrating Risk-based Care for Patients With Chronic Kidney Disease (CKD) in the Community|
|Actual Study Start Date :||August 24, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||December 2024|
Experimental: Active Knowledge Translation Group
Primary care clinics receiving the active knowledge translation intervention.
Other: Active Knowledge Translation
No Intervention: Control Group
Primary care clinics receiving the current standard of care. Information on personalized risk and risk-based referral will not be provided.
- Proportion of patients in each clinic who have albuminuria (albumin-creatinine ratio (ACR)) tested [ Time Frame: 1 year after intervention ]This will be determined using data extracted from each clinic's EMR.
- Proportion of patients with albuminuria in each clinic who are receiving treatment (ACEi/angiotensin receptor blockers (ARB)) [ Time Frame: 1 year after intervention ]This will be determined using data extracted from each clinic's EMR.
- Diabetes management for CKD patients [ Time Frame: 1 year after intervention ]Measured as the proportion of CKD patients who have a hemoglobin A1C in target (i.e. <8%).
- Hypertension management for CKD patients [ Time Frame: 1 year after intervention ]Measured as the proportion of CKD patients who have a normal blood pressure (BP), taken as part of regular clinic visit (office BP <130/80 for patients with diabetes, 140/90 for those without).
- Management of cardiovascular risk factors for CKD patients [ Time Frame: 1 year after intervention ]Measured as the proportion of CKD patients who have a statin prescription listed on their EMR.
- Drug safety for CKD patients [ Time Frame: 1 year after intervention ]Measured as the proportion of CKD patients who have a non-steroidal anti-inflammatory drug (NSAID) listed on their EMR.
- eGFR function for CKD patients [ Time Frame: 2 years after intervention ]Measured as the proportion of CKD patients who have a >30% decline in eGFR function.
- Appropriate referral for patients at high risk for kidney failure [ Time Frame: 1 year after intervention ]Determined through comparisons with provincial guidelines.
- Total Health Care Costs [ Time Frame: 1 year after intervention ]Direct health care costs will be estimated for both groups of patients taking a health care payor perspective, and estimated using linkages with provincial administrative data.
- Clinical provider's satisfaction with the risk prediction tools and clinical decision aids. [ Time Frame: 6 months after intervention ]Measured by the number of points as a result of the clinical providers' answers on a Likert scale.
- Patient's CKD-specific health literacy [ Time Frame: 6 months after intervention ]Measured by the number of points as a result of participants' answers to the validated Kidney Knowledge Survey (KiKS).
- Patient's trust in physician care [ Time Frame: 6 months after intervention ]Measured by the number of points as a result of participants' answers to the validated Trust in Physician Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365063
|Contact: Oksana Harasemiw, MScfirstname.lastname@example.org|
|Contact: Navdeep Tangri, MD PhD FRCPCemail@example.com|
|University of Manitoba||Recruiting|
|Winnipeg, Manitoba, Canada, R3T 2N2|
|Contact: Oksana Harasemiw, MSc 1-204-632-3541 firstname.lastname@example.org|
|Principal Investigator:||Navdeep Tangri, MD PhD FRCPC||University of Manitoba|