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Trials / Completed

CompletedNCT03832595

Kidney Coordinated Health Management Partnership

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,596 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
OTHEREHR-based PHMAn 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).
OTHERUsual CarePatients 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).

Timeline

Start date
2019-05-01
Primary completion
2022-07-31
Completion
2023-07-31
First posted
2019-02-06
Last updated
2025-08-22
Results posted
2024-04-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03832595. Inclusion in this directory is not an endorsement.

Kidney Coordinated Health Management Partnership (NCT03832595) · Clinical Trials Directory