A Risk Based Approach to Improving Chronic Kidney Disease Management
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim 1: To assess whether quality of care for stage 3 chronic kidney disease can be
      substantially improved over 18 months by:

        -  Point of care electronic alerts to primary care physicians recommending risk-appropriate
           care, and

        -  Quarterly mailings to patients providing self management support materials, including
           tailored recommendations based on personalized data from an electronic disease registry

      Aim 2: To assess the relationship between utilization of the intervention components and
      primary care physician attitudes towards both chronic kidney disease management and
      electronic reminder systems.
    

Detailed description: 
      Specific Aim 1 We will develop software to calculate the estimated glomerular filtration
      rates for all patients presenting to primary care physicians randomized to the intervention
      arm, and identify patients with an estimated glomerular filtration rates in the range of 30
      to 59. We will create three electronic alerts that intervention clinicians will receive upon
      accessing the patient chart based on whether the patient is high risk or low risk. These
      alerts will focus on recommending overdue laboratory tests (urine protein, blood cholesterol,
      etc), as well as recommending guideline appropriate medications (ACE inhibitors), and
      nephrology referral when appropriate.

      We will provide self management support materials to patients of primary care physicians
      randomized to the intervention arm. We will rely on primary care physicians to enroll
      patients by first recommending referral via the electronic alerts. On a monthly basis, we
      will identify patient visits during which an alert fired and no referral was placed. We will
      distribute a list of these patients to each physician via inter-office mail at least every
      other month. The mailing will ask physicians to return the list indicating which patients
      should be enrolled in the program, and our project manager will place the referrals. For
      non-responding physicians, we will follow up with a reminder email. The patient mailings will
      include recent clinical results and guideline-recommended targets, encouraging patients to
      become more proactive in the management of their kidney disease. Once a patient is enrolled
      in the program, they will receive similar mailings with updated personalized data and
      recommendations every 3 months.

      Electronic referrals placed by primary care physicians for management of chronic kidney
      disease will first be routed to the renal nurse, who will then initiate contact with the
      patient. A total of two telephone calls followed by a letter will be made to contact the
      patient. The nephrology visits will occur per standard clinical operations, including
      evaluation by an attending nephrologist, as well as educational sessions with the renal nurse
      and nutritionist. We will create new template notes within the electronic record for use by
      the nephrologists to communicate clinical care recommendations back to the primary care
      physicians.

      Prior to starting the intervention, the study team will travel to each of the 14 health
      centers to conduct orientation sessions with the primary care physicians. These sessions will
      provide general information regarding the goals and scope of the upcoming intervention,
      including demonstrations of the electronic alerts and the self management support outreach
      program. A similar overview will also be provided to the HVMA Division of Nephrology.

      We will randomize approximately 170 physicians into the intervention and control groups.
      Physicians in the intervention group will receive patient-specific alerts at the time of
      office visits for patients with Stage 3 kidney disease. Physicians in the control group will
      not receive active alerts.

      Data will all be obtained electronically from automated extracts from the electronic health
      record. Our study endpoints will be measured at 18 months and are specified according to risk
      status. The primary endpoints among high risk patients will be 1) the presence of an office
      visit in nephrology within the prior 12 months, and 2) the use of ACE inhibitors or ARBs for
      those with hypertension or microalbuminuria. The primary endpoints among low risk patients
      will include 1) a urine microalbumin result within the prior 12 months, and 2) the use of ACE
      inhibitors or ARBs for those with hypertension or microalbuminuria. Hypertension will be
      assessed based on the presence of a most recent blood pressure greater than 130/80 mmHg or a
      current diagnosis of hypertension on the electronic problem list. A secondary endpoint for
      both patient groups will be achieving a blood pressure less than 130/80 mmHg. We will also
      assess primary care physician awareness of chronic kidney disease defined as use of
      appropriate problem list and encounter diagnosis codes; and rates of annual serum LDL
      cholesterol, hemoglobin, phosphorous, 25-OH-vitamin D, calcium, and parathyroid hormone
      testing; as well as rates of LDL cholesterol control (<100 mg/ dL) and anemia management
      (hemoglobin > 11 g/dL).

      We will conduct an assessment of the self management support materials by surveying patients
      directly to assess 1) their ratings of the delivery of self-management support by our
      physician practice, 2) awareness of chronic kidney disease and treatment goals, and 3) the
      utility of the information contained in the patient mailings. These surveys will be conducted
      at two time points: baseline (first quarterly mailing) and completion of the study (final
      quarterly mailing). We will conduct the survey at two time points to facilitate an analysis
      of trends in patient experiences of care.

      To assess the impact of the intervention on each of our primary outcomes we will fit
      hierarchical logistic regression models with random effects for patients within physicians
      and physicians within centers. We will fit a set of similar models among three subgroups
      defined by number of patient visits with their primary care physician during the 18 month
      period (0 visits, 1-2 visits, ≥ 3 visits). We will fit two secondary models that include a
      third independent variable for race or sex. The effect of the intervention on reducing race
      or sex-based disparities will be assessed by examining race*group and sex*group interaction
      terms.

      Specific Aim 2 We will use the physician survey to collect data on primary care physician
      support for electronic reminders and patient self management, and preparedness to manage
      kidney disease. Physician responses will be collected using 5 point and 4 point Likert
      scales, and we will examine the distribution of responses for each survey item to create
      three dichotomous predictor variables of 1) high support for electronic reminders, 2) high
      support for patient self management, and 3) high preparedness for managing kidney disease.
      The primary outcomes will be the proportion of electronic alerts accompanied by ordering of
      1) the recommended treatment, or 2) referral for patient self management support. We will
      construct three separate linear regression models for each dichotomous predictor variable
      defined above, with the proportion of times that the appropriate decision support feature is
      used as a continuous outcome variable. The dichotomous physician survey outcome measures will
      be used as the primary independent variables. We will further assess the statistical
      significance of an interaction term between physician randomization status and each of the
      three dichotomous survey outcomes in our primary models from Specific Aim 2 to test whether
      electronic alerts are more or less effective depending on physician reported attitudes.
    

Intervention name(s): Electronic Decision Support
Intervention type(s): Other
Intervention description(s): Physicians randomized to the intervention will receive:
Electronic alerts during office visits for patients with chronic kidney disease
Opportunity to enroll their patients with chronic kidney disease in a self management support outreach program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Chronic kidney disease; Quality improvement; Self management support; Electronic health records; Clinical decision support; Electronic reminders; Patient outreach