Kidney Coordinated Health Management Partnership (Kidney-CHAMP)

• ClinicalTrials.gov Identifier: NCT03832595
• Recruitment Status: Enrolling by invitation
• First Posted: February 6, 2019
• Last Update Posted: May 11, 2020
• Sponsor: University of Pittsburgh
• Collaborators: Vanderbilt University Medical Center; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Manisha Jhamb, University of Pittsburgh

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Diseases	Other: Intervention Arm; Other: Usual Care	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1650 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Cluster randomized controlled trial with randomization occurring at the Primary Care Physician practice level
• Masking: Single (Outcomes Assessor)
• Masking Description: outcomes are ascertained by data programmers who are blinded to study arm assignment
• Primary Purpose: Treatment
• Official Title: Kidney Coordinated Health Management Partnership
• Actual Study Start Date: May 1, 2019
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: August 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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).	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).
Experimental: Intervention Arm; Patients will receive a care bundle	Other: Intervention Arm; 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).

Outcome Measures

Primary Outcome Measures :

1. Decline in estimated Glomerular Filtration Rate (eGFR) or End Stage Renal Disease (ESRD) [ Time Frame: Through study completion, an average of 24 months ]

   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 :

1. Hypertension (HTN) Control [ Time Frame: Through study completion, an average of 24 months ]
   Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR.
2. Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi) [ Time Frame: Through study completion, an average of 24 months ]
   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).
3. Composite medication safety: Inappropriate use of Non-Steroidal Anti-inflammatory Drugs (NSAIDs), glyburide, metformin, gemfibrozil, sodium glucose cotransporter 2 (SGLT2) inhibitors [ Time Frame: Through study completion, an average of 24 months ]
   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).
4. Medication safety: Use of Non-Steroidal Anti-inflammatory Drugs (NSAIDS) [ Time Frame: Through study completion, an average of 24 months ]

   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

5. Medication Safety: Use of glyburide [ Time Frame: Through study completion, an average of 24 months ]

   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

6. Medication Safety: Use of Metformin [ Time Frame: Through study completion, an average of 24 months ]

   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

7. Medication Safety: Use of SGLT2 inhibitors [ Time Frame: Through study completion, an average of 24 months ]

   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 SGLT2 inhibitors will be examined for all study patients with diabetes at baseline and eGFR less than 45

8. Medication Safety: Use of gemfibrozil [ Time Frame: Through study completion, an average of 24 months ]

   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

Other Outcome Measures:

1. Subgroup analysis: Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi) (outcome 3) in participants who are baseline non-users of RAASi [ Time Frame: Through study completion, an average of 24 months ]
   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).
2. Subgroup analysis hypertension (HTN) control (outcome 2) in participants with uncontrolled BP at baseline (i.e., BP >130/80 at baseline). [ Time Frame: Through study completion, an average of 24 months ]
   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.
3. 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, SGLT2 inhibitors [ Time Frame: Through study completion, an average of 24 months ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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

Contacts and Locations

Locations

United States, Pennsylvania

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Vanderbilt University Medical Center

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Khaled Abdel-Kader, MD; Vanderbilt University Medical Center
• Principal Investigator: Manisha Jhamb, MD MPH; University of Pittsburgh Medical Center

More Information

• Responsible Party: Manisha Jhamb, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03832595
• Other Study ID Numbers: PRO18070620; R18DK118460 ( U.S. NIH Grant/Contract ); 1R01DK116957-01A1 ( U.S. NIH Grant/Contract )
• First Posted: February 6, 2019
• Last Update Posted: May 11, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manisha Jhamb, University of Pittsburgh:

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

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency