Kidney Coordinated Health Management Partnership

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2023-07-31

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.

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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).

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial with randomization occurring at the Primary Care Physician practice level

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

outcomes are ascertained by data programmers who are blinded to study arm assignment

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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).

Intervention Arm

Patients will receive a care bundle

Group Type EXPERIMENTAL

EHR-based PHM

Intervention Type OTHER

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:

1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \~6 months,
2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \~6 months,
3. 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).

Interventions

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EHR-based PHM

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:

1. Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every \~6 months,
2. Medication therapy management: PharmD led telephonic medication therapy management with the patient every \~6 months,
3. 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).

Intervention Type OTHER

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. age greater than or equal to 18, and less than or equal to 85
2. most recent eGFR less than 60 ml/min/yr
3. established care with UPMC PCP
4. 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

1. history of kidney transplant
2. receiving maintenance dialysis
3. recent (within 12 months) outpatient nephrology visit
4. baseline eGFR less than 15ml/min
5. expected survival less than 6 months or hospice enrollee (e.g., stage IV heart failure, metastatic cancer, oxygen dependent Chronic Obstructive Pulmonary Disease)

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No