Improving Chronic Disease Management With Pieces
Condition: Chronic Kidney Disease; Diabetes; Hypertension; High BP; Type 2 Diabetes
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension; Diabetes Mellitus; Chronic Disease
Study type: Interventional

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.
    

Detailed description: 
      ICD-Pieces is a randomized, pragmatic clinical trial in four large healthcare systems to
      improve care of patients with coexistent chronic kidney disease, diabetes and hypertension.
      The investigators hypothesis is that patients who receive care with a collaborative model of
      primary care-subspecialty care enhanced by novel information technology (Pieces) and practice
      facilitators will have fewer all-cause hospitalizations, readmissions, disease-specific
      hospitalizations, Emergency Room visits, cardiovascular events and deaths than patients
      receiving standard medical care. The investigators will also aim to develop a better
      understanding of risk predictors in patients with chronic kidney disease, diabetes and
      hypertension to guide future recommendations of therapies that are tailored to individual
      patients.

      The primary objective of the study is to test the hypothesis that a collaborative model of
      primary care enhanced by novel information technology and practice facilitators will allow to
      leverage data from electronic health records to identify patients with the triad of chronic
      kidney disease, diabetes and hypertension using objective and reproducible criteria, and
      provide clinician support for implementation of best practices of care, monitoring clinical
      measures, adjusting treatments and reduce 12-month hospitalization rates. In this study
      disease-specific hospitalizations for chronic kidney disease, diabetes and hypertension
      include hospitalizations due to cardiovascular complications, congestive heart failure,
      volume overload, accelerated/malignant/uncontrolled hypertension, acute coronary syndromes,
      myocardial infarction, stroke, coronary/peripheral revascularization, limb
      ischemia/amputations, diabetes complications, uncontrolled diabetes, hypoglycemia, acute
      kidney injury, hyperkalemia, electrolyte disturbances, medication errors, drug toxicity, and
      infections.

      Secondary Objectives: The study will test if implementation of the collaborative model of
      primary care-subspecialty care interventions will reduce 30-day readmissions (for patients
      who are hospitalized), emergency room visits, cardiovascular events, deaths or
      disease-specific hospitalizations. In this study disease-specific hospitalizations for
      chronic kidney disease, diabetes and hypertension include hospitalizations due to
      cardiovascular complications, congestive heart failure, volume overload,
      accelerated/malignant/uncontrolled hypertension, acute coronary syndromes, myocardial
      infarction, stroke, coronary/peripheral revascularization, limb ischemia/amputations,
      diabetes complications, uncontrolled diabetes, hypoglycemia, acute kidney injury,
      hyperkalemia, electrolyte disturbances, medication errors, drug toxicity, and infections.

      2.) Develop and validate predictive models for risks of hospitalizations, emergency room
      visits, cardio vascular events and deaths for all patients with coexistent chronic kidney
      disease, diabetes and hypertension and predict risks of 30-day disease-specific readmissions
      for patients who are hospitalized.

      3.) Capture data (demographic, clinical, medications, laboratories, procedures) to phenotype
      patients with a triad of chronic kidney disease, diabetes and hypertension.

      4.) Obtain important safety data for patients with chronic kidney disease, diabetes and
      hypertension including adverse safety events, acute kidney injury and progression of chronic
      kidney disease (even for patients not hospitalized).

      5.) Obtain information on resource utilization including not only hospitalizations but also
      all emergency room visits, outpatient visits and diagnostic and therapeutic procedures.

      6.) Evaluate the impact of the collaboratory model of care on patient Reported Outcomes
      (PROs) including health-related quality of life, patient satisfaction, Patient perspective on
      quality of their care and measures of patient perception of burden related to care of their
      chronic kidney disease, diabetes and hypertension.

      7.) Evaluate the impact of the collaborative primary care-subspecialty care model on provider
      satisfaction with resources and ability to manage patients with coexistent chronic kidney
      disease, diabetes and hypertension.

      Study Outcome Measures:

      The primary outcome of this trial is all cause hospitalizations for patients with a triad of
      chronic kidney disease, diabetes and hypertension. Specifically, the outcome will be
      hospitalization rates at 12 months for study participants. The investigators will include
      both regular hospitalizations as defined by Center for Medicaid and Medicare(CMS) and
      observation status overnight (to avoid variations related to definition of inpatient
      status/hospitalization using the recent implementation of the "two midnight rule"
      CMS-1599-F).

      Study Design:

      The study will employ a prospective stratified cluster randomization design. The stratum is
      each of the four large healthcare systems participating in the study. The unit of
      randomization will be primary care clinics. In some healthcare systems several primary care
      clinics share the same geographic location and personnel and they will be randomized as a
      single unit.

      The cluster design of the study is best suited to detect important differences in outcomes
      between the intervention and control groups[8,55]. The decision to use primary care clinics
      as a unit for randomization in the study is based on the ability to implement different
      models of care in the active intervention sites as compared to the control sites. The
      collaborative model of care which includes novel information technology, subject
      identification, facilitation of patient care, monitoring of outcomes and participation from
      facilitators can be most efficiently applied to the workflow of clinics when they are fully
      randomized to active intervention. The cluster randomization design with clinics receiving
      collaborative primary care-subspecialty care versus standard care also limits the risk of
      cross-contamination between intervention and control groups in the study

      Primary care practices will be stratified by healthcare systems and randomly allocated to
      either intervention group or standard medical care group using a randomized permutation block
      within stratum. Based on the assignment of the clinic where a patient goes, each patient will
      be assigned either to the intervention group or the standard medical care group. All eligible
      patients of clinics who are randomized to the study will be included in the comparison of the
      two intervention groups regardless of intervention compliance (intention-to-treat analysis)
      to investigate if patients in intervention group have significantly less all-cause
      hospitalizations than those in the standard medical care group.

      Evaluation will also be performed to determine treatment effects on disease-specific
      hospitalizations, emergency room visits, cardiovascular events and deaths.

      There will be two study groups: active intervention group randomized to the collaborative
      model of care facilitated by novel information technology and practice facilitators and
      standard/usual care group.

      The intervention in the active group is implementation of a collaborative model of care that
      facilitates delivering best care practices to patients who have coexistent chronic kidney
      disease, type 2 diabetes and hypertension. The model uses a novel information technology
      platform called Pieces and practice facilitators with the purpose of allowing for early
      identification of patients with objective criteria and to implement best practices of care,
      monitor important clinical measures, adjust treatments and achieve improved outcomes. The
      intervention will be delivered in the outpatient setting.

      Data collection for assessment of study objectives will be mainly based on information
      technology tools to capture data from the electronic health record. Some data fields will
      require collection of data from Dallas Fort Worth Regional Hospital Council, ProHealth
      Accountable Care Organization databases, VA of North Texas and Social Security Death Files
      Index.

      A Data Safety Monitoring Board (DSMB) has been assembled by the National Institute of
      Diabetes and Digestive and Kidney Diseases (NIDDK) and will oversee study planning and
      implementation of the study.
    

Intervention name(s): Collaborative Model of Primary care and Subspecialty care
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): Collaborative model, Pieces and Practice Facilitator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic; Risk prediction model; Quality Improvement (QI); Pragmatic trial; Cluster randomization; Collaborative care; clinical informatics; Chronic kidney disease; hypertension; high BP; diabetes