麻豆传媒

A multi-pronged electronic health record-based population health management intervention failed to move the needle for slowing chronic kidney disease (CKD) progression, a cluster randomized trial showed.

Over a median follow-up of 17 months, patients with moderate- to high-risk CKD receiving either usual care or the specialized intervention had a similar risk for the primary outcome, a 40% or greater reduction in estimated glomerular filtration rate (eGFR) or progression to end-stage kidney disease (adjusted HR 0.96, 95% CI 0.67-1.38), reported Manisha Jhamb, MD, MPH, of the University of Pittsburgh School of Medicine, and colleagues.

Angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) exposure was more frequent in the intervention arm compared with the control group (rate ratio 1.21, 95% CI 1.02-1.43), they wrote in . This equated to 197 exposure days per year for intervention patients versus 163 days for usual care patients.

To help primary care practitioners (PCPs) co-manage complex CKD patients, the goal of the multidisciplinary intervention was "to provide a comprehensive assessment and management plan," the researchers explained. "Multidisciplinary care teams in CKD have been associated with a reduced risk of all-cause mortality, hospitalization, and eGFR decline and are advocated by recent clinical practice guidelines from the Kidney Disease Improving Global Outcomes and American Diabetes Association."

While the trial's results were "disappointing," noted Merrick Zwarenstein, MBBCH, PhD, of Western University in London, Ontario, and colleagues in an , the study should still be considered a "landmark on the way to a learning health system in which low-cost evaluations are seamlessly built into the implementation of every major innovation or change in care delivery."

One critique they had was that the "investigators seem to believe that the problem is lack of knowledge among PCPs and patients and that the solution is to deliver that knowledge as authoritative and individualized consultation reports directly to PCPs to prompt specific changes in their decisions on clinical care and initiation of patient education."

Specifically, this intervention strategy combined a nephrology electronic consultation, pharmacist-led medication management, and CKD education delivered to the primary care clinician's inbox and placed in the patient's health record within a week of their upcoming appointment. Pharmacists reviewed the patients' medication regimens for safety, ease of use, and affordability.

Then during the appointment, a real-time clinical decision support tool reminded the primary care clinician to review recommendations, place orders, and refer the patient for CKD education.

Within a month of that visit, nurse educators used telemedicine to provide personalized education to the patients. At this time, they also addressed kidney replacement therapy options, which included medical management without dialysis. Patients were able to opt out of the referral for education later in the trial due to poor rates of clinical referral.

"While the intervention had good face validity and its delivery of the nephrology and pharmacist consultations to PCPs was reliable, it did not overcome barriers to PCP and patient behavior change sufficiently to achieve its declared primary outcome," Zwarenstein and team pointed out.

That being said, the prespecified primary outcome may have been a tall order. "Given that preventing even a 10% or 20% decline has clinical and policy value, the trial may not exclude important benefit," they noted.

While the trial followed the patients for a median of 17 months, the commentators said one "tantalizing clue" that suggests the potential for delayed success in the intervention was the finding of more frequent ACE inhibitor/ARB exposure. Because of this, longer follow-up of the patients may be warranted.

The was a pragmatic cluster randomized trial conducted between May 2019 and July 2022 across 101 primary care practices in Western Pennsylvania. For inclusion, all patients had to have an eGFR of less than 60 mL/min/1.73m², high risk of CKD progression, and no outpatient nephrology encounter within the previous 12 months.

Of the 1,596 patients, 754 were randomized to the intervention and 842 to usual care. Mean age was 74, 58% were women, and 91% were white. Mean eGFR was 36.8 mL/min/1.73m². Baseline sociodemographic and clinical characteristics were similar between the two arms.

During the trial, 17% of patients died (19.2% of intervention patients and 16.9% of control patients). There was no difference in the secondary outcomes of hypertension control and exposure to unsafe medications or adverse events between the two study arms.

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