Evaluation of an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
Condition: Hypertension; Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Clinical Decision Support System (CDSS); Clinic Decision Sup System + Pharmacist
Intervention type(s): Other; Other
Intervention description(s): A targeted, automated CKD clinical decision support system (CDSS) designed to improve bloodpressure (BP) level, disease awareness, staging, processes of care, and knowledge among persons with documented reduced eGFRcreat (creatinine-based estimated glomerular filtration rate) in primary care setting.; Includes everything in the CDSS intervention but adds a follow-up call from a pharmacist, who is part of the clinical team. 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.
Other intervention name(s): CDSS Plus, Clinical Decision Support System + Pharmacist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening