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Summary

for people ages 18–80 (full criteria)
healthy people welcome
study started
estimated completion:

Description

Summary

The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or one of two intervention arms. The first intervention will evaluate the efficacy of an automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker test ordering, guideline implementation and BP management, compared with usual care, among patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP level, with secondary outcomes related to processes of care and patient knowledge.

Official Title

A Randomized Trial to Evaluate an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care

Details

Setting:

The investigators will conduct this study within the three General Internal Medicine (GIM) practices at UCSF. These include general internal medicine PCPs who practice primary care. This trial is specifically designed to work within the framework of the existing infrastructure of these practices.

Randomization:

The unit for randomization will be the PCP (MD and NPs with their own panel of patients); the investigators plan to include up to 105 PCPs.

Training and Pre-Trial Preparation:

Prior to the beginning of this trial, all eligible providers at the UCSF GIM practice will be informed of this trial by the PI via email, attached with consent information, at which time they will be sent a link to information about the Kidney Disease Improving Global Outcomes (KDIGO) guidelines, and they will have the opportunity to opt-out of the trial. PCP randomization will be performed by the study coordinator using an automated procedure. The PCPs randomized to the intervention arms (CDSS and CDSS PLUS) will have the option to view a brief training video designed by study PIs and IT experts on the automated CKD CDSS.

Blinding:

The analysts will remain blinded throughout the trial and data analyses.

Intervention Details (CKD CDSS):

The CKD CDSS has been developed by the study PIs and IT experts, and refined using physician feedback. While the tool will be automated as much as possible using the electronic medical record, provider decision making will be required at all diagnostic or treatment steps in the CDSS.

The study MD will order all of the triple marker CKD tests not yet done(creatinine, urine microalbumin, cystatin C). Once the tests are ordered, patients will proceed to the laboratory as they normally would in clinical practice. The EHR will be programmed to return the results to the PCP's clinical results folder in APeX, and to a study inbox monitored by the study MDs. Participating PCPs will be advised about tests being ordered along with a list of their eligible patients when sent the opt out letter prior to being randomized.

Best Practice Alert (BPA), Smart Set: The CDSS will allow a "second-chance" for test ordering if the tests are not completed prior to an enrolled patient encounter (for PCPs in the CDSS or CDSS Plus arms), by automatically delivering a reminder message embedded in the visit encounter as part of a best practice alert (BPA) indicating that the triple marker tests have been ordered but not completed for this patient. If the tests have been completed at the time of the visit, the BPA will give CKD staging based on the triple marker for the individual patient and have a button to click to open a smart smart-set tailored to that specific patient. The smart-set will cover the orders and recommendations as indicated for that patient: Blood pressure target, use of ACEI/ARB class of medications, potassium management, use of statin medications, pre-populated referral to nephrology when indicated, patient educational material on NSAIDS and CKD in general to populate the After Visit Summary.

CDSS PLUS: The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings. For PCPs in the CDSS PLUS intervention arm, the study will provide cards identifying the pharmacist on the clinical team. During the visit in which the CDSS launches, the PCPs can let the patient know that a pharmacist, who is part of the clinical team, will be calling to follow-up, and he/she can hand these cards out to eligible patients. In addition, the CDSS smart set for these patients will give information about the pharmacist that can populate the After Visit Summary. This warm hand-off will allow the patient to be aware of the reason for the pharmacist's post-visit call. For patients active on MyChart, the pharmacist will use MyChart to set up a good time to call the patient within two weeks. If the patient does not use MyChart, the pharmacist will attempt to call and leave messages for the patient. On the phone call, the pharmacist will discuss and collect data on the patient's understanding of CKD, conduct a medication review and adherence assessment, ask about home BP checks, and discuss the importance of NSAID avoidance.

All calls will be documented in APeX to allow the entire clinical team to follow the patient's care and route messages to the PCP and team RN as necessary. A second call from the pharmacist will only be triggered if the patient is non-adherent and makes an active plan for adherence requiring a follow-up call to check-in on that plan, or if the patient requests an additional follow-up call.

Keywords

Hypertension Renal Insufficiency, Chronic Renal Insufficiency

Eligibility

You can join if…

Open to people ages 18–80

  • Have at least two outpatient, documented eGFRcreat values 30- 59 ml/min/1.72m2 that are at least ≥3 months apart
  • At least one of these measurements should be within 12 months.
  • Patients have seen their primary care physician at least one time within the previous 18 months
  • Patient's primary care providers agree to participate

You CAN'T join if...

  • Patients actively and recently seen by nephrology clinic (at least once in the past 12 months)
  • Patients with a diagnosis of end stage renal disease
  • Persons aged >80
  • Persons with New York Heart Association (NYHA) class III or IV heart failure, known ejection fraction < 25%, or documented allergy to ace/arb.
  • Patients on dialysis, kidney transplant recipients and pregnant women
  • Patients with prevalent dementia, impaired cognition or severe mental illness;expected life expectancy < 6 months.

There will also be a category where the physician can opt out for specific patients in their panel due to not believing this person should be included in the study for any reason.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02925962
Lead Scientist
Carmen Alicia Peralta
Study Type
Interventional
Last Updated
July 20, 2017
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