Improving Chronic Disease Management With Pieces (ICD-Pieces)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02587936|
Recruitment Status : Recruiting
First Posted : October 27, 2015
Last Update Posted : October 12, 2018
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Chronic Disease Management With Pieces (ICD-Pieces)|
|Actual Study Start Date :||April 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
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
- 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.
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
|Contact: Adeola Jaiyeola, MD, MHScemail@example.com|
|Contact: George R Oliver, MD, PhDfirstname.lastname@example.org|
|United States, Connecticut|
|Farmington, Connecticut, United States, 06034|
|Contact: Tom Meehan, MD, MPH 860-284-5288 email@example.com|
|Contact: Stephanie Gemant, PharmD 860-674-7233 sgernant@ProHealthMD.com|
|Principal Investigator: Tom Meehan, MD, MPH|
|Sub-Investigator: Stepanie Gernant, 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|
|Dallas, Texas, United States, 75216|
|Contact: Tyler Miller, MD 214-648-7214 firstname.lastname@example.org|
|Contact: Anuoluwapo Adelodun, MD, MPH 435-557-0696 ANUOLUWAPO.ADELODUN@va.gov|
|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: Jill Sommerhauser, RN 214-266-1102 JILL.SOMMERHAUSER@phhs.org|
|Principal Investigator: Noel Santini, MD|
|Sub-Investigator: Jill SOMMERHAUSER, 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|