Kidney Coordinated Health Management Partnership

NCT03832595 | Completed Results

• 3 other identifiers: STUDY19060280R18DK1184601R01DK116957-01A1
• Study Type: interventional
• Target: 1,596
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

electronic health record; population health management; patient education; medication therapy management; electronic consultation; randomized controlled trial; pragmatic trial

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  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

Secondary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (2)

• Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g

  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)

• Hypertension (HTN) Control for Achieved BP <130/80 mm Hg

  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)

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Intervention Arm

EXPERIMENTAL

Patients will receive a care bundle

Other: EHR-based PHM

Interventions

EHR-based PHM 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).

Intervention Arm

Usual Care 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).

Usual care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Vanderbilt University Medical Center: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Jhamb M, Weltman MR, Yabes JG, Kamat S, Devaraj SM, Fischer GS, Rollman BL, Nolin TD, Abdel-Kader K. Electronic health record based population health management to optimize care in CKD: Design of the Kidney Coordinated HeAlth Management Partnership (K-CHAMP) trial. Contemp Clin Trials. 2023 Aug;131:107269. doi: 10.1016/j.cct.2023.107269. Epub 2023 Jun 20.

  PMID: 37348600 BACKGROUND

• Jhamb M, Weltman MR, Devaraj SM, Lavenburg LU, Han Z, Alghwiri AA, Fischer GS, Rollman BL, Nolin TD, Yabes JG. Electronic Health Record Population Health Management for Chronic Kidney Disease Care: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2024 Jul 1;184(7):737-747. doi: 10.1001/jamainternmed.2024.0708.

  PMID: 38619824 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Lower duration of follow-up period due to COVID-19 pandemic related delays

Results Point of Contact

• Title: Dr. Manisha Jhamb
• Organization: University of Pittsburgh

jhambm@upmc.edu

4126477062

Study Officials

• Khaled Abdel-Kader, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Manisha Jhamb, MD MPH

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes are ascertained by data programmers who are blinded to study arm assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 6, 2019
• Study Start: May 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2023
• Last Updated: August 22, 2025
• Results First Posted: April 18, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)