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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK118460 | U.S. NIH Grant/Contract | View source | |
| 1R01DK116957-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Vanderbilt University Medical Center | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Intervention Arm | Experimental | Patients will receive a care bundle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension (HTN) Control Outcome | HTN control is defined as achieved BP<140/90mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g | Outcome 3 will be repeated in the subgroup of participants receiving RAASi who have macroalbuminuria, 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). |
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:
Exclusion Criteria for PCPs: none
Exclusion Criteria for patients:
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| Name | Affiliation | Role |
|---|---|---|
| Khaled Abdel-Kader, MD | Vanderbilt University Medical Center | Principal Investigator |
| Manisha Jhamb, MD MPH | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37348600 | Background | 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. | |
| 38619824 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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18,157 participants from 101 practices underwent initial screening. Out of these 1,803 from 9 practices were eligible at initial screening, which included 874 (from 50 practices) in control arm, and 929 (from 4 practices) in intervention arm.
Patients who had confirmed eligibility after initial screening and had a PCP appointment within 1 year of eligibility screening were enrolled. In intervention group, patients or PCPs who opted-out at this stage were not enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Patients will receive a care bundle 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:
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). |
| FG001 | 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). 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Patients will receive a care bundle 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:
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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | 95% Confidence Interval | percent | 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 | Primary care practice | Primary care practice |
Over the entire study follow-up period, median follow-up 17 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | Patients will receive a care bundle 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:
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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hyperkalemia | Renal and urinary disorders | Non-systematic Assessment | Electrolytes |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate hyperkalemia (Serum potassium 5.5 - 6 meQ/L) | Renal and urinary disorders | Non-systematic Assessment | Electrolytes |
Lower duration of follow-up period due to COVID-19 pandemic related delays
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manisha Jhamb | University of Pittsburgh | 4126477062 | jhambm@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2019 | Mar 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Cluster randomized controlled trial with randomization occurring at the Primary Care Physician practice level
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outcomes are ascertained by data programmers who are blinded to study arm assignment
|
| 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). |
|
| 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 | 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). Reported as exposure days per year rate for each arm | 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 | 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). Reported as exposure days per year rate for each arm NSAIDS use will be examined for all study patients | 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 | 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). Reported as Exposure days per year rate for each arm Glyburide use will be examined for all study patients with diabetes at baseline | 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 | 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). Reported as Exposure days per year rate for each arm Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30 | 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: Gemfibrozil Exposure Days | We will examine the rate of use of gemfibrozil among those with eGFR<30 at baseline | Time to event analysis - Follow up duration until primary outcome or a competing event was achieved or until end of intervention period (max 39 months) |
| 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 | HTN control is defined as achieved BP<130/80mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control | 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) |
| BG001 | 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). 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). |
| BG002 | Total | Total of all reporting groups |
| Primary care practice |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg | Participants |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg | Participants |
|
| Serum Creatinine | Mean | Standard Deviation | mg/dL | Participants |
|
| eGFR CKD-EPI | Mean | Standard Deviation | ml/min/1.73m^2 | Participants |
|
| Urine Albumin-creatinine ratio | Median | Inter-Quartile Range | UACR mg/g | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Intervention Arm | Patients will receive a care bundle 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:
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). |
| OG001 | 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). 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). |
|
|
|
| Secondary | Hypertension (HTN) Control Outcome | HTN control is defined as achieved BP<140/90mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control | Posted | Least Squares Mean | 95% Confidence Interval | log-odds per month slope | 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) | Primary care practices | Primary care practices |
|
|
|
|
| Secondary | Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year | 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). Reported as exposure days per year rate for each arm | Posted | Least Squares Mean | 95% Confidence Interval | 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) | Primary care practice | Primary care practice |
|
|
|
|
| Secondary | Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year | 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). Reported as exposure days per year rate for each arm NSAIDS use will be examined for all study patients | Posted | Least Squares Mean | 95% Confidence Interval | 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) | Primary care practice | Primary care practice |
|
|
|
|
| Secondary | Medication Safety: Glyburide Exposure Days Per Year | 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). Reported as Exposure days per year rate for each arm Glyburide use will be examined for all study patients with diabetes at baseline | Posted | Least Squares Mean | 95% Confidence Interval | 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) | Primary care practice | Primary care practice |
|
|
|
|
| Secondary | Medication Safety: Metformin Exposure Days Per Year | 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). Reported as Exposure days per year rate for each arm Use of metformin will be examined for all study patients with diabetes at baseline and eGFR less than 30 | Posted | Least Squares Mean | 95% Confidence Interval | 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) | Primary care practice | Primary care practice |
|
|
|
|
| Secondary | Medication Safety: Gemfibrozil Exposure Days | We will examine the rate of use of gemfibrozil among those with eGFR<30 at baseline | Although Gemfibrozil was a pre-specified secondary outcome, it was excluded from analyses since among those with eGFR<30 at baseline, active use was found only in 1 patient control arm) and there is no statistically meaningful way of analyzing this | Posted | Time to event analysis - Follow up duration until primary outcome or a competing event was achieved or until end of intervention period (max 39 months) | Primary care practice | Primary care practice |
|
|
| Other Pre-specified | Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g | Outcome 3 will be repeated in the subgroup of participants receiving RAASi who have macroalbuminuria, 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). | Posted | Least Squares Mean | 95% Confidence Interval | medication 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 Pre-specified | Hypertension (HTN) Control for Achieved BP <130/80 mm Hg | HTN control is defined as achieved BP<130/80mmHg. Outpatient, sitting Blood Pressure (BP) values measured during each outpatient encounter and recorded in the EHR. All BPs within a 6-month window are averaged to account for ascertainment bias and then analyzed using generalized linear mixed model for average BP as binary outcome. Result is reported as log-odds per month slope for each arm. Higher log-odds indicates higher rate of BP control | Posted | Least Squares Mean | 95% Confidence Interval | log-odds per month slope | 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) |
|
|
|
| 142 |
| 754 |
| 18 |
| 754 |
| 59 |
| 754 |
| EG001 | 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). 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). | 130 | 842 | 21 | 842 | 77 | 842 |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |