UH3 Project: Improving Chronic Disease Management with Pieces (ICD-Pieces™)
Overview
Principal Investigator:
Sponsoring Institution: University of Texas Southwestern Medical Center
Collaborators:
- Parkland Health and Hospital System
- Texas Health Resources
- VA North Texas Health Care System
- ProHealth Physicians of Connecticut
NIH Institute Providing Oversight: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Program Official: Susan Mendley, MD (NIDDK)
Project Scientist: Kevin Chan, MD (NIDDK)
ClinicalTrials.gov Identifier: NCT02587936
Study Locations: Texas, Connecticut
Trial Status: Enrollment completed
Trial Summary
Study question and significance: Chronic kidney disease, type 2 diabetes, and hypertension are common medical conditions that are often present together and cause many complications. Despite the availability of effective, guideline-directed therapies for these coexisting conditions, large clinical trials examining their implementation in clinical practice are lacking.
Design and setting: Cluster randomized clinical trial with 11,182 patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension recruited between July 2016 and June 2019 from 141 primary care practices in 4 large healthcare systems in the United States.
Intervention and methods: Patients were randomly assigned to receive either usual care or an intervention that used an electronic health record–based algorithm to identify patients and employed practice facilitators who worked with participating primary care providers and patients to meet blood pressure targets, promote use of appropriate medications, achieve goals for blood glucose control, and engage in other guideline-directed care. The primary outcome was hospitalization for any reason at 1 year. Key secondary outcomes included emergency department visits, cardiovascular events, and death.
Findings: At 1 year, the hospitalization rate for any cause was similar between the intervention and the usual care group. The risks of secondary outcomes, such as emergency department visits, cardiovascular events, and most adverse events, were also similar between the groups. Acute kidney injury was observed in more patients in the intervention group than in the usual care group.
Conclusions and relevance: A multicomponent primary care intervention for patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension did not reduce the hospitalization rate for these patients when compared to usual care.
Data and Resource Sharing
- Vazquez ICD-Pieces Reg-Ethics Minutes Suppl Material
ICD-Pieces UH2 Ethics and Regulatory Documentation
- ICDPieces_Vazquez_UH3_Follow-up
ICD-Pieces ethics and regulatory documentation - UH3 project updates
Featured Interviews
Drs. Vazquez and Oliver discuss recent lessons learned in the Improving Chronic Disease Management with Pieces™ (ICD-Pieces) NIH Collaboratory Trial.
News and Interviews
- News_ ICD-Pieces Trial Sees No Reduction in Hospitalization for Patients With Chronic Kidney Disease
April 4, 2024: ICD-Pieces Trial Sees No Reduction in Hospitalization for Patients With Chronic Kidney Disease
- News_Results of ICD-Pieces to Be Presented in This Week’s PCT Grand Rounds
June 21, 2023: Results of ICD-Pieces to Be Presented in This Week’s PCT Grand Rounds
- Video_Update on the ICD-Pieces Demonstration Project
Video Interview: Update on the ICD-Pieces NIH Collaboratory Trial
- News_ICD-Pieces Credits Communication and Collaboration
June 16, 2022: ICD-Pieces Credits Communication and Collaboration for a Successful Trial
- News_PCT Grand Rounds to Highlight Experiences From ICD-Pieces
March 29, 2022: PCT Grand Rounds to Highlight Experiences From ICD-Pieces
- News_Online NIH Course on Pragmatic and Group-Randomized Trials
January 24, 2017: New Online NIH Course on Pragmatic and Group-Randomized Trials
- Video-interview_Vazquez
Video Interview: Interview with Miguel Vazquez, MD
- Video-Interview-Vazquez-04-20-15
Video Interview: An Interview with Dr. Miguel Vazquez
- Vazquez-Interview-2017
Written Interview: Interview With the PI of ICD-Pieces
Publications
- Vazquez et al N Engl J Med 2024
ICD-Pieces Main Outcome Paper
- Xu et al Stat Med 2019
Sample size considerations for stratified cluster randomization design with binary outcomes and varying cluster size
- de Boer et al J Am Soc Nephrol 2016
Pragmatic clinical trials in CKD: opportunities and challenges
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which PCTs Should Have a DMC?
- Living Textbook Chapter_Inpatient Endpoints in Pragmatic Clinical Trials
Living Textbook Chapter: Endpoints and Outcomes: Inpatient Endpoints in Pragmatic Clinical Trials
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
- Living Textbook Chapter_Monitoring Intervention and Fidelity Adaptions
Living Textbook Chapter: Monitoring Intervention and Fidelity Adaptions: Intervention Adaptation Strategies and Examples
- Living Textbook Chapter_Monitoring Protocol Adherance
Living Textbook Chapter: Data and Safety Monitoring: Monitoring Protocol Adherance
- Living Textbook Chapter_Data Sharing and Embedded Research
Living Textbook Chapter: Data Sharing Solutions for Embedded Research
- Living Textbook Chapter_Participant Recruitment_Case Study ICD-Pieces
Living Textbook Chapter: Participant Recruitment: Case Study ICD-Pieces
- ICD-Pieces Study Snapshot
ICD-Pieces Study Snapshot
- Living Textbook Chapter_Partnering With Quality Improvement and Population Health Initiatives
Living Textbook Chapter: Dissemination and Implementation: Partnering With Quality Improvement and Population Health Initiatives
Presentations
- GR-Video-06-23-23
Improving Delivery of Care for Chronic Kidney Disease, Diabetes in Hypertension
- GR-Slides-06-23-23
Improving Delivery of Care for Chronic Kidney Disease, Diabetes in Hypertension
- ASN_2022_vazquez final
Lessons for AKI Research from Pragmatic Trials
- ASN2022_PosterFinal TH (002)
Improving Chronic Disease Management with Pieces (ICD Pieces)
- SC-Mtg-2023-Day1-Vazquez
Miguel Vazquez Presentation at 2023 Steering Committee Meeting
- 2022 NIH Workshop_Panel 4
2022 NIH Workshop Panel 4
- 2022 NIH Workshop_Panel 1
2022 NIH Workshop Panel 1 Presentation
- SC-Mtg-2022-Day-1-Vazquez
Dr. Miguel Vazquez's Presentation at 2022 Steering Committee Meeting
- SC-Mtg-2022-Day-2-Oliver
ICD-Pieces Presentation at 2022 Steering Committee Meeting
- GR-Video-04-01-22
ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems (GR Video 2022)
- GR-Slides-04-01-22
ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems (GR Slides 2022)
- GR-Video-06-26-20
EHR Core Workshop: Keys to Success in the Evolving EHR Environment (GR Video 2020)
- GR-Slides-06-26-20
EHR Core Workshop: Keys to Success in the Evolving EHR Environment (GR Slides 2020)
- SC-2019-Barriers-ICD-Pieces
Barriers and Challenges-ICD-Pieces
- Workshop Design and Analysis of PCT_Panel 2_To Cluster or Not to Cluster
Workshop Design and Analysis of PCT: Panel 2 - To Cluster or Not to Cluster
- GR-Video-03-29-19
ICD-Pieces: Lessons Learned in an Ongoing Trial (GR Video 2019)
- GR-Slides-03-29-19
ICD-Pieces: Lessons Learned in an Ongoing Trial (GR Slides 2019)
- 6_Vazquez_ICD-Pieces_-Barriers-Lessons_REVISED
ICD-Pieces: Improving Chronic Disease Management with Pieces (SC meeting presentation)
- Poster_ICDPieces_AcademyHealth_2017_c
Technology-Enhanced Implementation of Evidence-Based Care in the Primary Care Setting (AcademyHealth 2017)
- GR-Slides-11-17-17
ICD-Pieces: From Planning to Performance (GR Slides 2017)
- GR-Video-11-17-17
ICD-Pieces: From Planning to Performance (GR Video 2017)
- Vazquez-SC-May-2017
ICD Pieces: Top Barriers/Challenges and Recent Generalizable Lessons Learned
- Panel-2_Health-System-Engagement_Dissemination-Workshop_24MAY2017
A vs B Workshop Panel 2: Health System Engagement: Partnership, Relationships and Transparency
- Dissemination and Implementation Workshop Panel 2_HCS Engagement
Dissemination and Implementation Workshop Panel 2: Health System Engagement: Partnership, Relationships, and Transparency
- GR-Slides-09-23-16
ICD-Pieces: Early Implementation and Progress (GR Slides 2016)
- GR-Video-09-23-16
ICD-Pieces: Early Implementation and Progress (GR Video 2016)
- Workshop_Ethical and Regulatory Issues of PCTs_Privacy Issues
Workshop: Ethical and Regulatory Issues of PCTs: Privacy Issues
- Vazquez_ICD Pieces Data Sharing May 2016
ICD-Pieces: Data Governance and Data Sharing Presentation at Steering
- Vazquez_ICD Pieces Lessons and Sustainability May 2016
ICD-Pieces: Generalizable Lessons Learned Presentation at Steering Committee Meeting
- ICD-Pieces_Vazquez_04-21-15
ICD-Pieces_Vazquez_04-21-15