Kidney Coordinated Health Management Partnership

Not Applicable

Completed

Conditions: Chronic Kidney Diseases

Interventions: Other: EHR-based PHM
Other: Usual Care

Registration Number: NCT03832595

Lead Sponsor: University of Pittsburgh

Brief Summary: As part of a 42-month pragmatic, cluster randomized trial in 1,650 primary care patients with high-risk Chronic Kidney Disease (CKD), the investigators will test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM) intervention that targets improvements in the delivery of evidence-based CKD care.

Detailed Description: To test the effectiveness of a multifaceted Electronic Health Record (EHR)-based Population Health Management (PHM) intervention to improve the delivery of evidence-based Chronic Kidney Disease (CKD) care in patients with high-risk CKD. Investigators will perform a 42-month pragmatic, cluster randomized (at the practice level) controlled trial in 1,650 patients with high-risk CKD (as defined by validated risk prediction models or by current estimated Glomerular Filtration Rate (eGFR) value or recent decline in eGFR values) managed by their Primary Care Physicians (PCPs) to determine whether EHR-based PHM improves key processes of care and clinical outcomes.

The investigators hypothesize that EHR-based PHM will improve hypertension control, use of renin angiotensin aldosterone system inhibitors (RAASi), and avoidance of renally contraindicated medications (Aim 1a-1c) and delay CKD progression (Aim 2).

Investigators will also characterize the acceptability and experience of Primary Care Physicians (PCPs) in the intervention arm of the CKD PHM study (Aim 3).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1596

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	EHR-based PHM	Patients will receive a care bundle
Usual care	Usual Care	Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).

Primary Outcome Measures

Name	Time	Method
Renal Failure Event Defined as Greater Than or Equal to 40% Decline in Estimated Glomerular Filtration Rate (eGFR) or Occurrence of End Stage Renal Disease (ESRD)	Time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months). Cumulative % at 24 months reported	The outcome measure is occurrence of renal failure event and is defined as a greater than or equal to 40% decline in eGFR or occurrence of End Stage Renal Disease. The 40% decline in renal failure is a well accepted endpoint for renal failure in clinical trials and is approved by the FDA. eGFR decline will be adjudicated based on the baseline creatinine and eGFR determined from the CKD-epidemiology (CKD-EPI) equation and measured routinely in clinical practice. All eGFR values within 6-month windows will be averaged to account for ascertainment bias, and analyzed using discrete-time survival approach using generalized linear mixed model. ESRD will be defined as an eGFR less than or equal to 10ml/min, or starting of renal replacement therapy (dialysis or kidney transplant)

Secondary Outcome Measures

Name	Time	Method
Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year	Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)	Will be determined by active use of an Angiotensin-Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) based on the EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as exposure days per year rate for each arm
Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year	Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)	Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as exposure days per year rate for each arm NSAIDS use will be examined for all study patients
Medication Safety: Glyburide Exposure Days Per Year	Time to event analysis - Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period(max 39 months)	Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as Exposure days per year rate for each arm Glyburide use will be examined for all study patients with diabetes at baseline
Medication Safety: Metformin Exposure Days Per Year	Time to event analysis- Follow-up duration until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)	Investigators will examine the rates of use of several high-risk medications that can be associated with adverse outcomes in progressive CKD. Medication exposure will be determined by presence of the specified medication on the patient's EHR medication list at each outpatient encounter (cumulative person-time exposure during the study). Reported as Exposure days per year rate for each arm Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30
Hypertension (HTN) Control Outcome	Time to event analysis - until primary outcome or a competing event (death, medication management without dialysis, being moved to hospice care) was achieved or until the end of intervention period (max 39 months)	Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control
Medication Safety: Gemfibrozil Exposure Days	Time to event analysis - Follow up duration until primary outcome or a competing event was achieved or until end of intervention period (max 39 months)	We will examine the rate of use of gemfibrozil among those with eGFR\<30 at baseline