Trial Outcomes & Findings for Kidney Coordinated Health Management Partnership (NCT NCT03832595)
NCT ID: NCT03832595
Last Updated: 2025-08-22
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1596 participants
Primary outcome timeframe
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
Results posted on
2025-08-22
Participant Flow
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
Unit of analysis: Primary care practices
Participant milestones
| Measure |
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:
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
754 48
|
842 50
|
|
Overall Study
COMPLETED
|
575 48
|
711 50
|
|
Overall Study
NOT COMPLETED
|
179 0
|
131 0
|
Reasons for withdrawal
| Measure |
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:
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).
|
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).
|
|---|---|---|
|
Overall Study
Death
|
142
|
130
|
|
Overall Study
Medical management without dialysis
|
37
|
1
|
Baseline Characteristics
Kidney Coordinated Health Management Partnership
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=48 Primary care practice
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:
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).
|
Usual Care
n=50 Primary care practice
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).
|
Total
n=98 Primary care practice
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.8 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
73.4 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
73.6 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
409 Participants
n=5 Participants
|
519 Participants
n=7 Participants
|
928 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
345 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
668 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
748 Participants
n=5 Participants
|
831 Participants
n=7 Participants
|
1579 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
696 Participants
n=5 Participants
|
753 Participants
n=7 Participants
|
1449 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
754 participants
n=5 Participants
|
842 participants
n=7 Participants
|
1596 participants
n=5 Participants
|
|
Systolic Blood Pressure
|
131.1 mmHg
STANDARD_DEVIATION 16.6 • n=5 Participants
|
131.6 mmHg
STANDARD_DEVIATION 17.2 • n=7 Participants
|
131.4 mmHg
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Diastolic Blood Pressure
|
73.9 mmHg
STANDARD_DEVIATION 10.4 • n=5 Participants
|
74.4 mmHg
STANDARD_DEVIATION 10.8 • n=7 Participants
|
74.1 mmHg
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Serum Creatinine
|
1.7 mg/dL
STANDARD_DEVIATION 0.4 • n=5 Participants
|
1.7 mg/dL
STANDARD_DEVIATION 0.4 • n=7 Participants
|
1.7 mg/dL
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
eGFR CKD-EPI
|
37.1 ml/min/1.73m^2
STANDARD_DEVIATION 7.9 • n=5 Participants
|
36.6 ml/min/1.73m^2
STANDARD_DEVIATION 7.9 • n=7 Participants
|
36.8 ml/min/1.73m^2
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Urine Albumin-creatinine ratio
|
86.0 UACR mg/g
n=5 Participants
|
84.6 UACR mg/g
n=7 Participants
|
85.0 UACR mg/g
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 reportedThe 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)
Outcome measures
| Measure |
Intervention Arm
n=48 Primary care practice
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:
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).
|
Usual Care
n=50 Primary care practice
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).
|
|---|---|---|
|
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)
|
9.7 percent
Interval 6.6 to 12.7
|
10.9 percent
Interval 7.7 to 14.1
|
SECONDARY outcome
Timeframe: 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)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
Outcome measures
| Measure |
Intervention Arm
n=48 Primary care practices
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:
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).
|
Usual Care
n=50 Primary care practices
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).
|
|---|---|---|
|
Hypertension (HTN) Control Outcome
|
0.011 log-odds per month slope
Interval -0.002 to 0.024
|
0.0005 log-odds per month slope
Interval -0.012 to 0.013
|
SECONDARY outcome
Timeframe: 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)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
Outcome measures
| Measure |
Intervention Arm
n=48 Primary care practice
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:
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).
|
Usual Care
n=50 Primary care practice
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).
|
|---|---|---|
|
Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) Exposure Days Per Year
|
196.8 exposure days per year
Interval 174.9 to 219.0
|
163.1 exposure days per year
Interval 146.3 to 179.9
|
SECONDARY outcome
Timeframe: 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)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
Outcome measures
| Measure |
Intervention Arm
n=48 Primary care practice
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:
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).
|
Usual Care
n=50 Primary care practice
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).
|
|---|---|---|
|
Medication Safety: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) Exposure Days Per Year
|
5.3 exposure days per year
Interval 2.6 to 8.0
|
6.7 exposure days per year
Interval 3.7 to 9.7
|
SECONDARY outcome
Timeframe: 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)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
Outcome measures
| Measure |
Intervention Arm
n=48 Primary care practice
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:
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).
|
Usual Care
n=50 Primary care practice
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).
|
|---|---|---|
|
Medication Safety: Glyburide Exposure Days Per Year
|
2.4 exposure days per year
Interval -3.7 to 8.5
|
2.0 exposure days per year
Interval -1.6 to 5.7
|
SECONDARY outcome
Timeframe: 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)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
Outcome measures
| Measure |
Intervention Arm
n=48 Primary care practice
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:
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).
|
Usual Care
n=50 Primary care practice
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).
|
|---|---|---|
|
Medication Safety: Metformin Exposure Days Per Year
|
17.8 exposure days per year
Interval -6.5 to 42.2
|
16.0 exposure days per year
Interval -1.7 to 33.6
|
SECONDARY outcome
Timeframe: 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)Population: 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
We will examine the rate of use of gemfibrozil among those with eGFR\<30 at baseline
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)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).
Outcome measures
| Measure |
Intervention Arm
n=233 Participants
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:
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).
|
Usual Care
n=226 Participants
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).
|
|---|---|---|
|
Subgroup Analysis: Use of Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) (Outcome 3) in Participants With UACR ≥300 mg/g
|
177.5 medication exposure days per year
Interval 146.2 to 208.8
|
222.5 medication exposure days per year
Interval 182.9 to 262.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)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
Outcome measures
| Measure |
Intervention Arm
n=754 Participants
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:
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).
|
Usual Care
n=842 Participants
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).
|
|---|---|---|
|
Hypertension (HTN) Control for Achieved BP <130/80 mm Hg
|
0.086 log-odds per month slope
Interval 0.073 to 0.1
|
0.079 log-odds per month slope
Interval 0.066 to 0.092
|
Adverse Events
Intervention Arm
Serious events: 18 serious events
Other events: 59 other events
Deaths: 142 deaths
Usual Care
Serious events: 21 serious events
Other events: 77 other events
Deaths: 130 deaths
Serious adverse events
| Measure |
Intervention Arm
n=754 participants at risk
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:
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).
|
Usual Care
n=842 participants at risk
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).
|
|---|---|---|
|
Renal and urinary disorders
Severe Hyperkalemia
|
2.4%
18/754 • Number of events 23 • Over the entire study follow-up period, median follow-up 17 months
|
2.5%
21/842 • Number of events 28 • Over the entire study follow-up period, median follow-up 17 months
|
Other adverse events
| Measure |
Intervention Arm
n=754 participants at risk
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:
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).
|
Usual Care
n=842 participants at risk
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).
|
|---|---|---|
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Renal and urinary disorders
Moderate hyperkalemia (Serum potassium 5.5 - 6 meQ/L)
|
7.8%
59/754 • Number of events 87 • Over the entire study follow-up period, median follow-up 17 months
|
9.1%
77/842 • Number of events 107 • Over the entire study follow-up period, median follow-up 17 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place