Chronic Kidney Disease Clinical Decision Support
Condition: Chronic Kidney Diseases; Hypertension; Diabetes
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension
Study type: Interventional

Summary: 
      To prevent serious chronic kidney disease (CKD) complications such as end-stage renal disease
      and cardiovascular events, better strategies are needed to identify, treat, and refer CKD
      patients seen in primary care clinics. This project expands an existing and successful
      Web-based clinical decision support (CDS) system to include key elements of CKD care and
      rigorously assesses the impact of this intervention on quality of CKD care for patients seen
      in primary care settings, including better recognition of CKD, better management of blood
      pressure and glucose, and more timely referral to nephrologists when appropriate. This
      low-cost and highly scalable intervention has high potential to improve CKD care and
      translate massive public and private sector investments in health informatics into tangible
      health benefits for large numbers of patients with CKD.
    

Detailed description: 
      Clinics are randomly allocated 1:1 through a computer-generated program to either control or
      intervention.

      Control Clinics. All control clinics will continue to use the basic Electronic Medical Record
      (EMR)-linked CDS for cardiovascular (CV) risk factor management. This CDS includes
      algorithmically derived identification of high CV risk patients and prioritized treatment
      suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin
      use based on distance from goal, current medications, labs, allergies, and safety
      considerations. The basic CDS does not include information specific to CKD care.

      Intervention Clinics. The CKD-CDS intervention provides updated clinical recommendations at
      any primary care visit for patients meeting inclusion and exclusion criteria. This presents
      patients and their primary care providers (PCPs) multiple opportunities to consider an
      evolving array of timely, evidence-based treatment options to improve CKD care. The CKD-CDS
      intervention is rooted in a series of antecedent studies that developed more limited but
      successful forms of CDS. From an operational point of view, implementing CKD-CDS at
      intervention clinics requires a series of 4 distinct steps that occur at every encounter:

      Step 1: Data exchange and evaluation: The EMR securely exchanges data with the Web Service at
      every encounter of patients aged 18-75 triggered by BP entry.

      Step 2: Recognition of CKD and presence of care deficits: Patients with stage 3-4 CKD are
      automatically identified by the Web Service and evaluated using algorithms maintained in the
      Web service for identification of CKD and for the 5 emphasized care gaps (identification of
      CKD, BP control, glucose control, Angiotensin converting enzyme inhibitor (ACEI)/Angiotensin
      receptor blocker (ARB) use if appropriate, and nephrology consultation if appropriate). If
      the patient has a care gap, the rooming staff receives an immediate best practice advisory
      (BPA) prompt to print CDS materials for the patient and the provider to review and use for
      shared decision making. Using a sequence of steps successfully implemented in previous
      studies, the rooming staff will print the materials and give the lay version to the patient
      to review while waiting for the provider. A professional version is left on the door for the
      provider to review before entering the exam room. This approach has been well-liked by our
      providers to help them be prepared and to engage patients in their care needs before the
      clinician-patient interaction. PCPs can also optionally view an electronic version of the CDS
      materials. The CDS can be viewed in real time for any patient by clicking on a button
      programmed in the EMR encounter display.

      Step 3: Use of CKD-CDS recommendations as shared decision-making tools: The participating
      providers and all rooming staff in the intervention clinics will be trained in the use of the
      PCP (professional) and patient (low-literacy) versions of the CKD-CDS. For this study, the
      CDS tool will be adapted to emphasize CKD and, for each identified deficit in CKD care, the
      CKD-CDS will display patient-specific recommendations consistent with then-current national
      CKD clinical guidelines; for example: (a) recognize CKD and ask the PCP to enter a CKD
      diagnosis on the problem list if indicated, and/or (b) specific considerations for how to
      modify BP control, glucose control, or ACEI/ARB therapy, and/or (c) refer certain patients to
      nephrology when referral criteria are met. The PCP assesses patient preference for any of the
      CKD-related treatment options. If the patient wants to act on 1 or more, the PCP can address
      it then or schedule a subsequent visit for that purpose. If the patient is not interested in
      any option, no further action is needed at that day's visit. The decision support provided to
      the PCP is very specific and, if pharmacotherapy is indicated, decision support specifies
      either initiation or titration of specific drugs based on the drugs/doses the patient is
      currently taking, distance from goal, and other clinical considerations outlined above. The
      patient version of the CKD-CDS uses symbols to provide easy patient recognition of priority
      clinical areas and then suggests potential treatment options they can discuss with their
      provider. Presenting key CKD care recommendations when indicated (all of which are evidence
      based and capable of improving CKD care) allows the patient freedom to select his or her
      preferred treatment option from among several potentially beneficial treatment options.
      Because patient readiness to take health-related actions varies across specific actions,
      offering several options improves the chance that a given patient may be interested in
      addressing at least 1 of the evidence-based options presented. Moreover, patient readiness to
      act is a key predictor of subsequent adherence and success of treatment, as we have
      previously shown in this patient population. It is important to realize that the printed page
      the patient receives frames the discussion to a set of prioritized evidence-based treatment
      options with likely benefit to the patient.

      Step 4. Take action based on the decisions made: After discussing with the patient, the
      provider can then go ahead and order the recommendations suggested by the CDS such as labs,
      medication, e-consults with nephrology, and referrals to specialists. All actions taken are
      also based on the provider's clinical judgement.
    

Intervention name(s): CKD enhanced clinical decision support
Intervention type(s): Other
Intervention description(s): The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinic level cluster randomized study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Chronic Kidney Disease; CKD; Clinical Decision Support; Diabetes; Hypertension