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Improving Chronic Disease Management With Pieces (ICD-Pieces)

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ClinicalTrials.gov Identifier: NCT02587936
Recruitment Status : Recruiting
First Posted : October 27, 2015
Last Update Posted : August 1, 2017
Sponsor:
Collaborators:
Parkland Center for Clinical Innovation
Parkland Health & Hospital System
Texas Health Resources
Connecticut Center for Primary Care
Dallas VA Research Corporation
G-Health Enterprises
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Diabetes Hypertension High BP Type 2 Diabetes Other: Collaborative Model of Primary care and Subspecialty care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10991 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Chronic Disease Management With Pieces (ICD-Pieces)
Actual Study Start Date : April 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587936


Contacts
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

Locations
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)         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Parkland Center for Clinical Innovation
Parkland Health & Hospital System
Texas Health Resources
Connecticut Center for Primary Care
Dallas VA Research Corporation
G-Health Enterprises
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Miguel Vazquez, MD UTSouthwestern Medical Center
Study Director: Robert Toto, MD UTSouthwestern Medical Center
Study Director: Tyler Miller, MD North Texas VA

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 )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 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