Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02587936 |
| Other study ID # |
STU 062015-016 |
| Secondary ID |
4UH3DK104655-021 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 18, 2016 |
| Est. completion date |
October 15, 2022 |
Study information
| Verified date |
March 2024 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
ICD-Pieces (Parkland Intelligent e-Coordination and Evaluation System) trial is a National
Institutes of Health (NIH) Healthcare Systems(HCS) Collaboratory demonstration project to
improve management of patients with a triad of Chronic Kidney Disease, hypertension and
diabetes with Pieces in four HCS including Parkland, Texas Health Resources (THR), ProHealth
Physicians Incorporation and North Texas VA. Pieces is a decision support technology platform
created by Parkland Center for Clinical Innovation(PCCI).
The primary objective is to test the hypothesis that a collaborative model of primary care
and subspecialty care intervention enhanced by Pieces and practice facilitators compared to
standard clinical practice will reduce all-cause hospitalizations in patients with coexisting
chronic kidney disease, diabetes and hypertension.
Secondary objectives are: a)Test if implementation of the collaborative model will reduce
30-day readmissions, emergency room visits, cardiovascular events or deaths and
disease-specific hospitalizations; b) Develop and validate risk predictive models for
disease-specific hospitalizations, all-cause hospitalizations, 30-day readmissions, emergency
room visits, cardiovascular events and deaths for patients with chronic kidney disease,
diabetes and hypertension. c) Collect demographic and clinical data to assist phenotyping
patients with chronic kidney disease, diabetes and hypertension. d) Obtain safety data
including Acute Kidney Injury, progression of chronic kidney disease, electrolyte
disturbances and medication errors, and drug toxicity; e) Collect resource utilization
information including hospitalizations, emergency room visits, outpatient visits, and
diagnostic or therapeutic procedures completed.
Candidate patients in selected clinics will be enrolled over a period of 2 years and followed
for 12 months. Pieces will ascertain both primary and secondary outcomes from the Electronic
Health Record supported with data from the Dallas Fort Worth Hospital Council (DFWHC),
Accountable Care Organization (ACO) reports and VA database, and deaths from Social Security
Index (SSI) data.
Description:
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.
