search
Back to results

Kidney Coordinated Health Management Partnership (Kidney-CHAMP)

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EHR-based PHM
Usual Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring electronic health record, population health management, patient education, medication therapy management, electronic consultation, randomized controlled trial, pragmatic trial

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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 for PCPs: none

Exclusion Criteria for patients:

  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)
  6. active substance dependence or severe/uncontrolled psychiatric condition

Sites / Locations

  • UPMC Presbyterian

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Intervention Arm

Arm Description

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).

Patients will receive a care bundle

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Hypertension (HTN) Control
Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR.
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).
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).
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
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
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
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

Full Information

First Posted
January 30, 2019
Last Updated
September 8, 2023
Sponsor
University of Pittsburgh
Collaborators
Vanderbilt University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT03832595
Brief Title
Kidney Coordinated Health Management Partnership
Acronym
Kidney-CHAMP
Official Title
Kidney Coordinated Health Management Partnership
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Vanderbilt University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
electronic health record, population health management, patient education, medication therapy management, electronic consultation, randomized controlled trial, pragmatic trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster randomized controlled trial with randomization occurring at the Primary Care Physician practice level
Masking
Outcomes Assessor
Masking Description
outcomes are ascertained by data programmers who are blinded to study arm assignment
Allocation
Randomized
Enrollment
1596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Patients will receive a care bundle
Intervention Type
Other
Intervention Name(s)
EHR-based PHM
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
Decline in estimated Glomerular Filtration Rate (eGFR) or End Stage Renal Disease (ESRD)
Description
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).
Time Frame
Through study completion, an average of 24 months
Secondary Outcome Measure Information:
Title
Hypertension (HTN) Control
Description
Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR.
Time Frame
Through study completion, an average of 24 months
Title
Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi)
Description
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).
Time Frame
Through study completion, an average of 24 months
Title
Composite medication safety: Inappropriate use of Non-Steroidal Anti-inflammatory Drugs (NSAIDs), glyburide, metformin, gemfibrozil
Description
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).
Time Frame
Through study completion, an average of 24 months
Title
Medication safety: Use of Non-Steroidal Anti-inflammatory Drugs (NSAIDS)
Description
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
Time Frame
Through study completion, an average of 24 months
Title
Medication Safety: Use of glyburide
Description
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
Time Frame
Through study completion, an average of 24 months
Title
Medication Safety: Use of Metformin
Description
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
Time Frame
Through study completion, an average of 24 months
Title
Medication Safety: Use of gemfibrozil
Description
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
Time Frame
Through study completion, an average of 24 months
Other Pre-specified Outcome Measures:
Title
Subgroup analysis: Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi) (outcome 3) in participants who are baseline non-users of RAASi
Description
Outcome 3 will be repeated in the subgroup of participants not receiving RAASi at baseline (i.e., In patients not receiving RAASi at study enrollment, RAASi use 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).
Time Frame
Through study completion, an average of 24 months
Title
Subgroup analysis hypertension (HTN) control (outcome 2) in participants with uncontrolled BP at baseline (i.e., BP >130/80 at baseline).
Description
Outcome 2 will be repeated in the subgroup of patients with suboptimal BP control (i.e., BP >130/80) at baseline using outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR.
Time Frame
Through study completion, an average of 24 months
Title
Subgroup analysis of composite medication safety (outcome 4) in the subgroup of participants receiving at least 1 of the following medications inappropriately at study enrollment: NSAIDs, glyburide, metformin, gemfibrozil
Description
Outcome 4 will be repeated in the subgroup of patients who were receiving at least 1 high-risk medication at study enrollment (baseline). 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).
Time Frame
Through study completion, an average of 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled Abdel-Kader, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manisha Jhamb, MD MPH
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kidney Coordinated Health Management Partnership

We'll reach out to this number within 24 hrs