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Improving Chronic Disease Management With Pieces (ICD-Pieces)
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Purpose
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.
| Condition | Intervention |
|---|---|
| Chronic Kidney Disease Diabetes Hypertension High BP Type 2 Diabetes | Other: Collaborative Model of Primary care and Subspecialty care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Other |
| Official Title: | Improving Chronic Disease Management With Pieces (ICD-Pieces) |
- All cause hospitalizations for patients with a triad of chronic kidney disease, diabetes and hypertension [ Time Frame: 12 months ]Hospitalization rates at 12 months for all study participants, capturing all cause unplanned hospitalizations including both regular hospitalizations as currently defined by CMS and observation status overnight. Hospitalizations will be ascertained from Electronic Health Record of each participating healthcare system with assistance from Pieces.
- 30-day all cause readmissions (for those patients who have an index hospitalization) [ Time Frame: 12 months ]30-day all cause readmissions (for those patients who have an index hospitalization), emergency room visits, cardiovascular events and deaths, and disease-specific hospitalizations for cardiovascular complications, congestive heart failure, volume overload, hypertension complications, acute coronary syndrome, myocardial infarction, coronary/peripheral revascularization, stroke, amputation/limb ischemia, uncontrolled diabetes, hypoglycemia, diabetes complications, acute kidney injury, hyperkalemia, electrolyte disturbances, medication errors, drug toxicity and infections.
| Estimated Enrollment: | 10991 |
| Actual Study Start Date: | April 2016 |
| Estimated Study Completion Date: | August 2019 |
| Estimated Primary Completion Date: | August 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Collaborative model
Group to receive Collaborative model of primary care and subspecialty care enhanced by Pieces and Practice Facilitator
|
Other: Collaborative Model of Primary care and Subspecialty care
Pieces will access Electronic Health Record for all patients receiving care at the participating sites to detect patients with a triad of chronic kidney disease, diabetes and hypertension, facilitate management and monitor outcomes. To maximize successful implementation of care, a Practice Facilitator will be at each site with standardized role training using a curriculum based on the Agency for Healthcare Research and Quality (AHRQ) Practice Facilitation Handbook. Specific interventions are maintaining BP less than 140/90 mmHg, use of angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), treatment with statins, aiming for glycosylated Hemoglobin (HgA1C) at the recommended target, and avoiding nephrotoxic medications. Additional interventions include chronic kidney disease education for Primary Care Providers (PCP) and patients using National Kidney Disease Education Program (NKDEP) materials.
Other Name: Collaborative model, Pieces and Practice Facilitator
|
|
No Intervention: Standard Care
Group to receive regular care
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02587936
| Contact: Adeola Jaiyeola, MD, MHSc | 214-590-3073 | adeola.jaiyeola@phhs.org | |
| Contact: George R Oliver, MD, PhD | 214-590-3072 | george.oliver@phhs.org |
| United States, Connecticut | |
| ProHealth | Recruiting |
| Farmington, Connecticut, United States, 06034 | |
| Contact: Tom Meehan, MD, MPH 860-284-5288 tmeehan@prohealthmd.com | |
| Contact: Alli Levine, RN 860-284-7322 alevine@ProHealthMD.com | |
| Principal Investigator: Tom Meehan, MD, MPH | |
| Sub-Investigator: Alli Levine, PharmD | |
| United States, Texas | |
| Texas Health Resources | Recruiting |
| Arlington, Texas, United States, 76011 | |
| Contact: Ferdinand Velasco, MD 682-236-6061 ferdinandvelasco@TexasHealth.org | |
| Contact: Lynn Myers, MD 817-991-5198 LynnMyers@texashealth.org | |
| Principal Investigator: Ferdinand Velasco, MD | |
| Sub-Investigator: Lynn Myers, MD | |
| Sub-Investigator: Velile Nkolomi, RN | |
| Veteran's Administration | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Susan Hedayati, MD 214-857-2214 Susan.Hedayati@va.gov | |
| Contact: Tyler Miller, MD 214-648-7214 tyler.miller@va.gov | |
| Principal Investigator: Susan Hedayati, MD | |
| Sub-Investigator: Tyler Miller, MD | |
| Sub-Investigator: Anuoluwapo Adelodun, MD, MPH | |
| Parkland Health and Hospital System | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Noel Santini, MD 214-266-1224 NOEL.SANTINI@phhs.org | |
| Contact: Oliaku Idigo, MSN, RN, BBA 214-266-1102 OLIAKU.IDIGO@phhs.org | |
| Principal Investigator: Noel Santini, MD | |
| Sub-Investigator: Oliak Idigo, MSN, RN, BBA | |
| Sub-Investigator: Kristin Ashton, LVN, (BSN) | |
| Principal Investigator: | Miguel Vazquez, MD | UTSouthwestern Medical Center |
| Study Director: | Robert Toto, MD | UTSouthwestern Medical Center |
| Study Director: | Tyler Miller, MD | North Texas VA |
More Information
| Responsible Party: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT02587936 History of Changes |
| Other Study ID Numbers: |
4UH3DK104655-02 ( U.S. NIH Grant/Contract ) |
| Study First Received: | September 14, 2015 |
| Last Updated: | May 9, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | We are obliged to share our data within the analytic team of the ICD-Pieces trial. The authors will retain the rights to the de-identified final data until the trial is completed. Interested parties will be able to download information about the predictive model from the PCCI website: www.pccipieces.org Short term data storage of transfer files will occur via encrypted drives between password protected encrypted computers |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by University of Texas Southwestern Medical Center:
|
Chronic Risk prediction model Quality Improvement (QI) Pragmatic trial Cluster randomization Collaborative care |
clinical informatics Chronic kidney disease hypertension high BP diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hypertension Kidney Diseases Renal Insufficiency, Chronic Chronic Disease Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Urologic Diseases Renal Insufficiency Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on July 17, 2017