Chronic Kidney Disease Clinical Decision Support

NCT ID: NCT03890588

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-17
• Study Completion Date: 2021-09-29

Brief 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.

Conditions

Chronic Kidney Diseases; Hypertension; Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

CKD enhanced clinical decision support (CKD-CDS Intervention)

Priority Wizard CDS tool is enhanced to incorporate chronic kidney disease(CKD) management. 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 CDS also provides CV risk factor management like the basic Priority Wizard present in the usual care arm.

Group Type: EXPERIMENTAL

CKD enhanced clinical decision support

Intervention Type: OTHER

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.

Usual Care

A basic Priority Wizard CDS tool for cardiovascular (CV) risk factor management (previously know as the CV Wizard) 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. Has no decision support specific to CKD care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CKD enhanced clinical decision support

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 75 years, inclusive. The evidence-based guidelines on which the CDS intervention is based are not applicable outside this age range.

2. Have confirmed CKD based on 2 or more estimated glomerular filtration rate (eGFR) values <60 cc/min/1.73m2, including the most recent eGFR value and a previous eGFR at least one week prior

3. Have a CKD care component suboptimally managed as defined by one or more of the following:

1. Have two or more BP values from separate encounter dates of >=130/80 including the most recent BP to the index visit

2. Have an individualized A1C over goal as determined by CDS algorithm criteria of most recent glycated hemoglobin (A1C) > 7% OR > 8% if any of the following conditions are identified: cardiovascular disease (CVD) or calculated 10-yr atherosclerotic cardiovascular disease (ASCVD) risk >30%, cancer, hypoglycemia, cognitive impairment, on 2 or more glycemia medications with insulin, or on 3 or more non-insulin glycemia medications

3. Have most recent eGFR 30-59 with hypertension identified or albumin to creatinine ratio (ACR) > 30 mg/g and not on an ACEI or ARB

4. Have non-steroidal anti-inflammatory drug (NSAID) other than aspirin on the active medication list

5. Have a eGFR 15-29 or ACR > 300 mg/g without a nephrology visit in the last 12 months

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from receiving the

CKD-CDS:

1. Patients enrolled in hospice,

2. Patients with active cancer or undergoing chemotherapy

3. Patients with pregnancy in the last year

4. Patients with end stage renal disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JoAnn M Sperl-Hillen, MD

Role: PRINCIPAL_INVESTIGATOR

Senior Investigator, HealthPartners Institute

Locations

HealthPartners Care System

Bloomington, Minnesota, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R18DK118463-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A17-353

Identifier Type: -

Identifier Source: org_study_id