Improving Chronic Disease Management With Pieces

ICD-Pieces is a randomized, pragmatic clinical trial in four large healthcare systems to
improve care of patients with coexistent chronic kidney disease, diabetes and hypertension.
The investigators hypothesis is that patients who receive care with a collaborative model of
primary care-subspecialty care enhanced by novel information technology (Pieces) and practice
facilitators will have fewer all-cause hospitalizations, readmissions, disease-specific
hospitalizations, Emergency Room visits, cardiovascular events and deaths than patients
receiving standard medical care. The investigators will also aim to develop a better
understanding of risk predictors in patients with chronic kidney disease, diabetes and
hypertension to guide future recommendations of therapies that are tailored to individual
patients.

The primary objective of the study is to test the hypothesis that a collaborative model of
primary care enhanced by novel information technology and practice facilitators will allow to
leverage data from electronic health records to identify patients with the triad of chronic
kidney disease, diabetes and hypertension using objective and reproducible criteria, and
provide clinician support for implementation of best practices of care, monitoring clinical
measures, adjusting treatments and reduce 12-month hospitalization rates. In this study
disease-specific hospitalizations for chronic kidney disease, diabetes and hypertension
include hospitalizations due to cardiovascular complications, congestive heart failure,
volume overload, accelerated/malignant/uncontrolled hypertension, acute coronary syndromes,
myocardial infarction, stroke, coronary/peripheral revascularization, limb
ischemia/amputations, diabetes complications, uncontrolled diabetes, hypoglycemia, acute
kidney injury, hyperkalemia, electrolyte disturbances, medication errors, drug toxicity, and
infections.

Secondary Objectives: The study will test if implementation of the collaborative model of
primary care-subspecialty care interventions will reduce 30-day readmissions (for patients
who are hospitalized), emergency room visits, cardiovascular events, deaths or
disease-specific hospitalizations. In this study disease-specific hospitalizations for
chronic kidney disease, diabetes and hypertension include hospitalizations due to
cardiovascular complications, congestive heart failure, volume overload,
accelerated/malignant/uncontrolled hypertension, acute coronary syndromes, myocardial
infarction, stroke, coronary/peripheral revascularization, limb ischemia/amputations,
diabetes complications, uncontrolled diabetes, hypoglycemia, acute kidney injury,
hyperkalemia, electrolyte disturbances, medication errors, drug toxicity, and infections.

2.) Develop and validate predictive models for risks of hospitalizations, emergency room
visits, cardio vascular events and deaths for all patients with coexistent chronic kidney
disease, diabetes and hypertension and predict risks of 30-day disease-specific readmissions
for patients who are hospitalized.

3.) Capture data (demographic, clinical, medications, laboratories, procedures) to phenotype
patients with a triad of chronic kidney disease, diabetes and hypertension.

4.) Obtain important safety data for patients with chronic kidney disease, diabetes and
hypertension including adverse safety events, acute kidney injury and progression of chronic
kidney disease (even for patients not hospitalized).

5.) Obtain information on resource utilization including not only hospitalizations but also
all emergency room visits, outpatient visits and diagnostic and therapeutic procedures.

6.) Evaluate the impact of the collaboratory model of care on patient Reported Outcomes
(PROs) including health-related quality of life, patient satisfaction, Patient perspective on
quality of their care and measures of patient perception of burden related to care of their
chronic kidney disease, diabetes and hypertension.

7.) Evaluate the impact of the collaborative primary care-subspecialty care model on provider
satisfaction with resources and ability to manage patients with coexistent chronic kidney
disease, diabetes and hypertension.

Study Outcome Measures:

The primary outcome of this trial is all cause hospitalizations for patients with a triad of
chronic kidney disease, diabetes and hypertension. Specifically, the outcome will be
hospitalization rates at 12 months for study participants. The investigators will include
both regular hospitalizations as defined by Center for Medicaid and Medicare(CMS) and
observation status overnight (to avoid variations related to definition of inpatient
status/hospitalization using the recent implementation of the "two midnight rule"
CMS-1599-F).

Study Design:

The study will employ a prospective stratified cluster randomization design. The stratum is
each of the four large healthcare systems participating in the study. The unit of
randomization will be primary care clinics. In some healthcare systems several primary care
clinics share the same geographic location and personnel and they will be randomized as a
single unit.

The cluster design of the study is best suited to detect important differences in outcomes
between the intervention and control groups[8,55]. The decision to use primary care clinics
as a unit for randomization in the study is based on the ability to implement different
models of care in the active intervention sites as compared to the control sites. The
collaborative model of care which includes novel information technology, subject
identification, facilitation of patient care, monitoring of outcomes and participation from
facilitators can be most efficiently applied to the workflow of clinics when they are fully
randomized to active intervention. The cluster randomization design with clinics receiving
collaborative primary care-subspecialty care versus standard care also limits the risk of
cross-contamination between intervention and control groups in the study

Primary care practices will be stratified by healthcare systems and randomly allocated to
either intervention group or standard medical care group using a randomized permutation block
within stratum. Based on the assignment of the clinic where a patient goes, each patient will
be assigned either to the intervention group or the standard medical care group. All eligible
patients of clinics who are randomized to the study will be included in the comparison of the
two intervention groups regardless of intervention compliance (intention-to-treat analysis)
to investigate if patients in intervention group have significantly less all-cause
hospitalizations than those in the standard medical care group.

Evaluation will also be performed to determine treatment effects on disease-specific
hospitalizations, emergency room visits, cardiovascular events and deaths.

There will be two study groups: active intervention group randomized to the collaborative
model of care facilitated by novel information technology and practice facilitators and
standard/usual care group.

The intervention in the active group is implementation of a collaborative model of care that
facilitates delivering best care practices to patients who have coexistent chronic kidney
disease, type 2 diabetes and hypertension. The model uses a novel information technology
platform called Pieces and practice facilitators with the purpose of allowing for early
identification of patients with objective criteria and to implement best practices of care,
monitor important clinical measures, adjust treatments and achieve improved outcomes. The
intervention will be delivered in the outpatient setting.

Data collection for assessment of study objectives will be mainly based on information
technology tools to capture data from the electronic health record. Some data fields will
require collection of data from Dallas Fort Worth Regional Hospital Council, ProHealth
Accountable Care Organization databases, VA of North Texas and Social Security Death Files
Index.

A Data Safety Monitoring Board (DSMB) has been assembled by the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) and will oversee study planning and
implementation of the study.

Inclusion Criteria

- CKD Inclusion Criteria (present at least ≥ 3 months apart)

1. There will be two or more Estimated Glomerular Filtration Rate (eGFRs)
calculations less than 60ml/minute (corrected for BSA) or

2. Two or more positive tests for albuminuria and/or proteinuria
Albuminuria/proteinuria can be defined by quantitative criteria with
albumin/creatinine ratio greater than 30mg/g, urine protein creatinine ratio
greater than 200mg/g or positive dipstick with protein detection (adjusted for
urinary concentration/specific gravity).

- Diabetes Inclusion Criteria Only patients with type 2 diabetes will be enrolled in
this study.

1. Random blood glucose greater than 200mg/dL

2. Hemoglobin A1C greater than 6.5%

3. Use of hypoglycemic agents or

4. Type 2 diabetes included in problem list

- Hypertension Inclusion Criteria

1. Systolic blood pressure greater than 140 mmHg on two different occasions at least
one week apart

2. Diastolic blood pressure greater than 90 on two occasions at least more than one
week apart

3. Use of antihypertensive agents except thiazide diuretics or

4. Hypertension included in problem list

Exclusion Criteria:

- Exclusion criteria will be minimal in this pragmatic trial. The collaborative model of
care will not be implemented in patients younger than 18 years or older than 85 years
of age or patients who have CKD stage 5/End Stage Renal Disease(ESRD.

- Primary care practitioners have the option of not implementing the intervention on any
of their patients if they believe benefit to be minimal or risk too high due to
patient comorbidities