— Secondary outcomes also showed no significant differences

Kristen Monaco, Senior Staff Writer, MedPage Today

Using a personalized algorithm to identify primary care patients with chronic kidney disease (CKD), type 2 diabetes, and hypertension (the kidney-dysfunction triad) — plus practice facilitators to help providers deliver guideline-based interventions — didn’t move the needle for reducing hospitalizations, the ICD-Pieces study found.

At 1 year, the hospitalization rate of patients in the intervention group was about the same as that with usual care (20.7% vs 21.1%, P=0.58), Miguel Vazquez, MD, of University of Texas Southwestern Medical Center in Dallas, and colleagues reported in the New England Journal of Medicine.

While the intervention missed the mark for cutting hospitalizations, Vazquez underscored the importance of improving care for patients with the kidney-dysfunction triad.

“Patients with this triad are at high risk for multiple complications, end stage kidney disease, and premature death,” he told MedPage Today. Although there are effective interventions for all three of these conditions, detection and awareness of CKD tends to be low and many patients therefore miss interventions that could be beneficial, he added.

The two-part intervention used in this pragmatic, open-label trial first used an algorithm to identify patients in the electronic health record in real time. Then practice facilitators, such as population health nurses and pharmacists, helped primary care providers implement evidence-based interventions. A patient registry and system-specific tools — like best practice alerts, smart sets, and protocols — were available only to providers and practice facilitators in the intervention group.

The intervention was rolled out in 71 primary care clinics across four large health care systems and enrolled 5,690 patients with the kidney-dysfunction triad. In comparison, 70 practices enrolled 5,492 kidney-dysfunction triad patients into the usual-care group, which were treated as normal without access to trial registries or practice facilitators.

In both groups, the average age was 69 years, 54% were male and 73% were white. Baseline HbA1c was around 7.6%, BMI was 33, blood pressure was 133/74 mm Hg, and around 20% had proteinuria levels between 30 to 300 mg/g. The majority were on a statin, ACE inhibitor or ARB, a beta-blocker, and a non-insulin agent.

As with the primary outcome, none of the six secondary outcomes of the trial significantly differed between the intervention and usual-care groups:

  • Emergency department visits: 24.3% of intervention vs 22.6% of usual care
  • Hospital readmission 30 days or less after first inpatient treatment: 37.7% vs 37.3%
  • Cardiovascular events: 18.5% vs 19.4%
  • Cardiovascular procedures: 1.9% vs 1.8%
  • Dialysis: 0.7% vs 0.6%
  • Death: 2.3% vs 2.7%

Cardiovascular events included acute coronary syndrome, heart failure, and stroke, while cardiovascular procedures included cardiac catheterization and revascularization.

Despite no differences in these outcomes, more patients in the intervention group had an updated problem list, adopted targets for blood pressure and HbA1c, and had documentation of the receipt of education regarding the kidney-dysfunction triad. More intervention patients were also newly prescribed an ACE inhibitor or ARB (11% vs 6%).

Although the trial missed its primary endpoint, Vazquez said his group felt this study was “an important step in advancing our understanding of how to conduct pragmatic trials embedded within healthcare systems.”

“It was possible to identify and enroll a large number of patients including members of groups who are usually underrepresented in large clinical trials,” he said. “There was fidelity to delivery of the intervention and robust capture of outcomes. The study provides lessons on how to test multicomponent interventions in patients with multiple chronic conditions.”

Some limitations of the study may explain why the intervention did not reduce hospitalizations, he noted. “It takes time for changes in processes of care to affect some clinical outcomes and the 1-year follow-up in the study may not have been long enough to observe differences between the groups,” Vazquez said.

“Another consideration is that the intervention could have been more effective if implemented earlier in the course of the disease process. There could have been also differences in adherence to treatment by patients, referrals to subspecialists, or other factors not captured in the study.”

“There are now some new therapies for patients with CKD, type 2 diabetes, and hypertension which could be of additional benefit in this patient population,” he added. Some of these newer therapies include SGLT2 inhibitors and GLP-1 receptor agonists, many of which have a combination of diabetes, kidney, and heart indications. Use of these two agent classes was low at baseline in both groups (under 6%).

  • Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.


The trial was supported by the National Institutes of Health (NIH).

Vazquez and co-authors reported relationships with the NIH, MelliCell, Astellas Pharma, Boehringer Ingelheim, Boston Clinical Research Institute, Centaurus Therapeutics, Cytokinetics, Entrada Therapeutics, Janssen Pharmaceuticals, Maze Therapeutics, Mission Therapeutics, NovMetaPharma, Variant Bio, National Center for Advancing Translational Sciences, National Institute of Diabetes and Digestive and Kidney Diseases, and UT Southwestern Medical Center.

Primary Source

New England Journal of Medicine

Source Reference: Vazquez MA, et al “Pragmatic trial of hospitalization rate in chronic kidney disease” N Engl J Med 2024; DOI: 10.1056/NEJMoa2311708.

Read More