N/A
N=18,268
Improving Chronic Disease Management With Pieces
Chronic Kidney Disease · Diabetes · Hypertension · High BP · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02587936 ↗Enrolled (actual)
18,268
Serious AEs
22.0%
Results posted
Dec 2023
Primary outcome: Primary: All Cause Hospitalizations for Patients With a Triad of Chronic Kidney Disease, Diabetes and Hypertension — 20.7; 21.12 percentage of participants hospitalized
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Collaborative Model of Primary care and Subspecialty care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Cause Hospitalizations for Patients With a Triad of Chronic Kidney Disease, Diabetes and Hypertension |
20.7; 21.12 | — |
| SECONDARY 30-day All Cause Readmissions (for Those Patients Who Have an Index Hospitalization) |
429; 433 | — |
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.
Eligibility Criteria
Inclusion Criteria
- CKD Inclusion Criteria (present at least ≥ 3 months apart)
- There will be two or more Estimated Glomerular Filtration Rate (eGFRs) calculations less than 60ml/minute (corrected for BSA) or
- 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.
- Random blood glucose greater than 200mg/dL
- Hemoglobin A1C greater than 6.5%
- Use of hypoglycemic agents or
- Type 2 diabetes included in problem list
- Hypertension Inclusion Criteria
- Systolic blood pressure greater than 140 mmHg on two different occasions at least one week apart
- Diastolic blood pressure greater than 90 on two occasions at least more than one week apart
- Use of antihypertensive agents except thiazide diuretics or
- 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
Data sourced from ClinicalTrials.gov (NCT02587936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.