Improving Chronic Disease Management With Pieces

NCT02587936 | Completed Results DMC

• 3 other identifiers: STU 062015-0164UH3DK104655-021UH2DK104655-01
• Study Type: interventional
• Target: 18,268
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Kidney Disease; Diabetes; Hypertension; High BP; Type 2 Diabetes

Keywords

Chronic; Risk prediction model; Quality Improvement (QI); Pragmatic trial; Cluster randomization; Collaborative care; clinical informatics; Chronic kidney disease; hypertension; high BP; diabetes

Outcome Measures

Primary Outcomes (1)

• All Cause Hospitalizations for Patients With a Triad of Chronic Kidney Disease, Diabetes and Hypertension

  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.

  12 months

Secondary Outcomes (1)

• 30-day All Cause Readmissions (for Those Patients Who Have an Index Hospitalization)

  12 months

Study Arms (2)

Collaborative model

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Group to receive regular care

Interventions

Collaborative Model of Primary care and Subspecialty care OTHER

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.

Also known as: Collaborative model, Pieces and Practice Facilitator

Collaborative model

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Parkland Center for Clinical Innovation: collaborator
• Parkland Health and Hospital System: collaborator
• Texas Health Resources: collaborator
• Connecticut Center for Primary Care: collaborator
• Dallas VA Research Corporation: collaborator
• G-Health Enterprises: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

ProHealth

Farmington, Connecticut, 06034, United States

Location

Texas Health Resources

Arlington, Texas, 76011, United States

Location

Veteran's Administration

Dallas, Texas, 75216, United States

Location

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Vazquez MA, Oliver G, Amarasingham R, Sundaram V, Chan K, Ahn C, Zhang S, Bickel P, Parikh SM, Wells B, Miller RT, Hedayati S, Hastings J, Jaiyeola A, Nguyen TM, Moran B, Santini N, Barker B, Velasco F, Myers L, Meehan TP, Fox C, Toto RD; ICD-Pieces Study Group. Pragmatic Trial of Hospitalization Rate in Chronic Kidney Disease. N Engl J Med. 2024 Apr 4;390(13):1196-1206. doi: 10.1056/NEJMoa2311708.

  PMID: 38598574 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Hypertension; Diabetes Mellitus, Type 2; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Miguel A Vazquez
• Organization: UT Southwestern Medical Center

Miguel.Vazquez@UTSouthwestern.edu

214-648-8884

Study Officials

• Miguel Vazquez, MD

  UTSouthwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Robert Toto, MD

  UTSouthwestern Medical Center

  STUDY DIRECTOR

• Tyler Miller, MD

  North Texas VA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor- Internal Medicine

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: October 27, 2015
• Study Start: July 18, 2016
• Primary Completion: March 1, 2022
• Study Completion: October 15, 2022
• Last Updated: April 2, 2024
• Results First Posted: December 20, 2023

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (4)