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Summary

Eligibility
for people ages 18–80
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion:
Principal Investigator
Carmen Alicia Peralta

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 it will evaluate whether a CDSS plus a pharmacist-led CKD management program (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge among the patients with newly confirmed higher-risk CKD (eGFRcreat-cys (<45) or eGFR (45-59) + ACR ≥30), 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 faculty physicians and residents who practice primary care in 10 clinical teams. This trial is specifically designed to work within the framework of the existing infrastructure of these practices.

Duration of Intervention Period:

12 months with total follow-up period of 18 months

Randomization:

The unit for randomization will be the PCP; there are 44 faculty physicians, 3 nurse practitioners (NPs) and 66 residents practicing in 10 clinical teams.

Training and Pre-Trial Preparation:

Prior to the beginning of this trial, all eligible PCPs at the UCSF GIM practice will have the opportunity for education on the Kidney Disease - Improving Global Outcomes (KDIGO) guidelines in the form of a Grand Rounds. All clinical providers will be informed of this trial by the PI via email at which time they will have the opportunity to opt-out. PCP randomization will be performed by the study coordinator using an automated procedure. The PCPs randomized to the intervention will have the option to view a 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, physician decision making will be required at all diagnostic or treatment steps in the CDSS. At the time the patient is enrolled, using the EHR, investigators will record the date of the next scheduled appointment with the PCP. If the patient has a scheduled visit within 90 days, the PCP will receive an initial in basket message 14 days before the scheduled visit. The purpose of this initial message is to alert the PCP that a patient is eligible for the CDSS and to facilitate ordering of tests prior to the study visit. At this point, the CDSS will offer the PCP three options: A) order the 3 tests, B) postpone, C) don't ask again. If the PCP chooses C, a menu of options will appear to select the reason why they are opting out. These include the exclusion criteria and "I do not deem this testing to be appropriate for this patient". If the patient is scheduled for an appointment>90 days in the future, the PCP will receive a similar message when the patient is identified as meeting enrollment criteria, followed by a subsequent message 14 days prior to the visit, as above.

The CDSS will allow a "second-chance" for test ordering if the order is not placed prior to the encounter, by engaging the medical assistant (MA). In GIM practice, the MA triages patients, obtaining vital signs and reviews due/overdue health care maintenance for that patient, and the MA is able to "pend" orders for the physician to consider and sign during the visit. In the case that the PCP has not yet ordered creatinine, cystatin C or ACR for an eligible patient, those orders will appear as health care maintenance "to-do's" for the MA to "pend". Study staff will check intervention PCP schedules on a monthly basis for upcoming appointments for eligible patients who were not previously scheduled. Once the tests are ordered, patients will proceed to the laboratory as they normally would in clinical practice. Patients will be alerted to pending labs via telephone call by the team MA (usual practice). Patients with a cell phone will receive an additional reminder via secure text message (newly available at UCSF).

Once the lab has performed the tests, results will appear in the physician's electronic inbox in the Results folder (where the PCP usually expects them). An additional customized result note will be sent to the PCP for each patient, flagged under CKD-action required folder, (see Figure 3) which includes recommended action items. These results will include a calculated eGFR by creatinine, cystatin C and combined creat-cys using CKD Epi equations.

For determination of CKD stage, the investigators will use the combined equation, as it has been shown to be the best estimate of measured glomerular filtration rate.

For each suggested action item, PCP signature will be required. Links to the KDIGO heat-map will be available. The note will include a reminder to educate the patient on CKD status and NSAID avoidance. A .dot phrase (a pre-populated phrase or template that appears when preceded by a 'dot' in any documentation area in Epic) to use in the assessment and plan section of the note and patient information section of the after visit summary will be available for PCPs to document patient education.

CDSS PLUS:

The rationale for this third arm is based on the evidence that clinical pharmacists and nurses have been shown to be more effective than physicians alone at achieving BP control in other settings. However, this requires much higher cost that an electronic CDSS alone and requires patients to attend many more extra appointments. Thus it is important to quantify the added benefit of a clinical pharmacist program, as well as expenditures, feasibility and acceptability, in order to identify the most effective and feasible interventions. Upon receipt of the referral from the PCP, the pharmacist will schedule a series of appointments aimed at BP control, initiation or up-titration of angiotensin converting enzyme (ACE) / angiotensin receptor blocker (ARB) therapy in those with albuminuria, assessment of medication risk and adherence, and education. At each visit, the pharmacist will measure and record three seated BP readings per guidelines, and will perform medication inventory. Management will follow a previously designed algorithm that follows established guidelines for management of high BP in persons with CKD. The goal is to achieve BP <140/90 mmHg and to use an ACE/ARB in those with albuminuria unless contraindicated. An option to a goal of <120/80 mmHg will also be available if requested by the PCP or if the results of the SPRINT study change guidelines. The intervention will last for 12 months. Initially, pharmacist follow-up visits will be every six weeks, and once a patient's BP is controlled in two or more consecutive visits, follow-up will be spaced out to every 12 weeks. At the end of 12 months, the pharmacist will no longer follow patients. To verify the fidelity of the intervention, the pharmacist will present several randomly chosen cases to the nephrologist involved in algorithm design (Dr. Peralta). The pharmacists will use previously used and tested CKD education (NKDEP) and NSAID education materials.

Keywords

Hypertension Renal Insufficiency, Chronic

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
  • 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 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
May 1, 2017
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