Kidney Coordinated Health Management Partnership

Study Overview
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Brief Summary
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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
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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).

Official Title
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Kidney Coordinated Health Management Partnership

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Other: EHR-based PHM
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for PCPs: presence of an ambulatory continuity clinic in the University of Pittsburgh Medical Center (UPMC) community medicine practice. Inclusion criteria for patients: age greater than or equal to 18, and less than or equal to 85 most recent eGFR less than 60 ml/min/yr established care with UPMC PCP high risk CKD based on validated external and internal risk prediction models or severe reduction in eGFR, or substantial loss in eGFR in prior 18 months. Exclusion Criteria for PCPs: none Exclusion Criteria for patients: history of kidney transplant receiving maintenance dialysis recent (within 12 months) outpatient nephrology visit baseline eGFR less than 15ml/min expected survival less than 6 months or hospice enrollee (e.g., stage IV heart failure, metastatic cancer, oxygen dependent Chronic Obstructive Pulmonary Disease)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial with randomization occurring at the Primary Care Physician practice level
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>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). | Other: Usual Care<br>* 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).<br>|
| Experimental: Intervention Arm<br>Patients will receive a care bundle | Other: EHR-based PHM<br>* An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive: Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every  6 months, Medication therapy management: PharmD led telephonic medication therapy management with the patient every  6 months, and Nurse led CKD patient education, every  6-12 months unless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decline in estimated Glomerular Filtration Rate (eGFR) or End Stage Renal Disease (ESRD) | A greater than or equal to 40% decline in eGFR or ESRD. 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. ESRD will be defined as an eGFR less than or equal to 10ml/min to account for patients with markedly reduced baseline eGFR values (i.e., 16-20ml/min). | Through study completion, an average of 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension (HTN) Control | Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. | Through study completion, an average of 24 months | 
| Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi) | 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). | Through study completion, an average of 24 months | 
| Composite medication safety: Inappropriate use of Non-Steroidal Anti-inflammatory Drugs (NSAIDs), glyburide, metformin, gemfibrozil | Investigators will examine the composite rate of use of these 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). | Through study completion, an average of 24 months | 
| Medication safety: Use of Non-Steroidal Anti-inflammatory Drugs (NSAIDS) | 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). NSAIDS use will be examined for all study patients | Through study completion, an average of 24 months | 
| Medication Safety: Use of glyburide | 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). Glyburide use will be examined for all study patients with diabetes at baseline | Through study completion, an average of 24 months | 
| Medication Safety: Use of Metformin | 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). Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30 | Through study completion, an average of 24 months | 
| Medication Safety: Use of gemfibrozil | 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). Use of gemfibrozil will be examined for all study patients with eGFR less than 30 | Through study completion, an average of 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic health record, population health management, patient education, medication therapy management, electronic consultation, randomized controlled trial, pragmatic trial