search
Back to results

Chronic Kidney Disease Clinical Decision Support (CKD-CDS)

Primary Purpose

Chronic Kidney Diseases, Hypertension, Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CKD enhanced clinical decision support
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases focused on measuring Chronic Kidney Disease, CKD, Clinical Decision Support, Diabetes, Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Individuals who meet all inclusion and exclusion criteria at an index visit and have at least one post-index visit in the following 12 months will be included in the primary analyses.

Sites / Locations

  • HealthPartners Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CKD enhanced clinical decision support (CKD-CDS Intervention)

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With CKD Diagnosis
Number of patients who had a CKD diagnosis document in the 18 months post index.
Number of Patients With Orders for Angiotensin-converting Enzyme Inhibitors (ACEI) or Angiotension II Reception Blockers (ARB)
Number of patients who had an Angiotensin-converting enzyme inhibitors (ACEI) or Angiotension II reception blockers (ARB) order in the 18 months post index.
Number of Patients With Optimal Blood Pressure Control
Number of patients for whom the average of the two most recent blood pressures prior to 18 months post index was <130/80.
Number of Patients With Optimal Glucose Control
Number of patients whose last A1c was <7% in the 1-18 months post index.
Number of Patients With Referral to Nephrology
Number of patients who have a referral to nephrology in the 18 months post index.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2019
Last Updated
November 7, 2022
Sponsor
HealthPartners Institute
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT03890588
Brief Title
Chronic Kidney Disease Clinical Decision Support
Acronym
CKD-CDS
Official Title
A Technology-Driven Intervention to Improve Identification and Management of Chronic Kidney Disease in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
September 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Hypertension, Diabetes
Keywords
Chronic Kidney Disease, CKD, Clinical Decision Support, Diabetes, Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinic level cluster randomized study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6295 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CKD enhanced clinical decision support (CKD-CDS Intervention)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CKD enhanced clinical decision support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With CKD Diagnosis
Description
Number of patients who had a CKD diagnosis document in the 18 months post index.
Time Frame
18-month period post index
Title
Number of Patients With Orders for Angiotensin-converting Enzyme Inhibitors (ACEI) or Angiotension II Reception Blockers (ARB)
Description
Number of patients who had an Angiotensin-converting enzyme inhibitors (ACEI) or Angiotension II reception blockers (ARB) order in the 18 months post index.
Time Frame
18-month period post index
Title
Number of Patients With Optimal Blood Pressure Control
Description
Number of patients for whom the average of the two most recent blood pressures prior to 18 months post index was <130/80.
Time Frame
18-month period post index
Title
Number of Patients With Optimal Glucose Control
Description
Number of patients whose last A1c was <7% in the 1-18 months post index.
Time Frame
1 to 18-month period post index
Title
Number of Patients With Referral to Nephrology
Description
Number of patients who have a referral to nephrology in the 18 months post index.
Time Frame
18-month period post index

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 75 years, inclusive. The evidence-based guidelines on which the CDS intervention is based are not applicable outside this age range. 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 Have a CKD care component suboptimally managed as defined by one or more of the following: Have two or more BP values from separate encounter dates of >=130/80 including the most recent BP to the index visit 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 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 Have non-steroidal anti-inflammatory drug (NSAID) other than aspirin on the active medication list 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: Patients enrolled in hospice, Patients with active cancer or undergoing chemotherapy Patients with pregnancy in the last year Patients with end stage renal disease Individuals who meet all inclusion and exclusion criteria at an index visit and have at least one post-index visit in the following 12 months will be included in the primary analyses.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JoAnn M Sperl-Hillen, MD
Organizational Affiliation
Senior Investigator, HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Care System
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11904577
Citation
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
Results Reference
background
PubMed Identifier
24647050
Citation
Inker LA, Astor BC, Fox CH, Isakova T, Lash JP, Peralta CA, Kurella Tamura M, Feldman HI. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis. 2014 May;63(5):713-35. doi: 10.1053/j.ajkd.2014.01.416. Epub 2014 Mar 16.
Results Reference
background
PubMed Identifier
23732715
Citation
Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
Results Reference
background
PubMed Identifier
29146535
Citation
Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available. Erratum In: J Am Coll Cardiol. 2018 May 15;71(19):2275-2279.
Results Reference
background
PubMed Identifier
15298234
Citation
Andrade SE, Gurwitz JH, Field TS, Kelleher M, Majumdar SR, Reed G, Black R. Hypertension management: the care gap between clinical guidelines and clinical practice. Am J Manag Care. 2004 Jul;10(7 Pt 2):481-6.
Results Reference
background
PubMed Identifier
14984450
Citation
Grant RW, Cagliero E, Dubey AK, Gildesgame C, Chueh HC, Barry MJ, Singer DE, Nathan DM, Meigs JB. Clinical inertia in the management of Type 2 diabetes metabolic risk factors. Diabet Med. 2004 Feb;21(2):150-5. doi: 10.1111/j.1464-5491.2004.01095.x.
Results Reference
background
PubMed Identifier
16186262
Citation
Phillips LS, Ziemer DC, Doyle JP, Barnes CS, Kolm P, Branch WT, Caudle JM, Cook CB, Dunbar VG, El-Kebbi IM, Gallina DL, Hayes RP, Miller CD, Rhee MK, Thompson DM, Watkins C. An endocrinologist-supported intervention aimed at providers improves diabetes management in a primary care site: improving primary care of African Americans with diabetes (IPCAAD) 7. Diabetes Care. 2005 Oct;28(10):2352-60. doi: 10.2337/diacare.28.10.2352.
Results Reference
background
PubMed Identifier
28207923
Citation
van Dipten C, van Berkel S, van Gelder VA, Wetzels JFM, Akkermans RP, de Grauw WJC, Biermans MCJ, Scherpbier-de Haan ND, Assendelft WJJ. Adherence to chronic kidney disease guidelines in primary care patients is associated with comorbidity. Fam Pract. 2017 Aug 1;34(4):459-466. doi: 10.1093/fampra/cmx002.
Results Reference
background
PubMed Identifier
21242556
Citation
O'Connor PJ, Sperl-Hillen JM, Rush WA, Johnson PE, Amundson GH, Asche SE, Ekstrom HL, Gilmer TP. Impact of electronic health record clinical decision support on diabetes care: a randomized trial. Ann Fam Med. 2011 Jan-Feb;9(1):12-21. doi: 10.1370/afm.1196.
Results Reference
background
Citation
Sperl-Hillen JM, O'Connor PJ, Averbeck BM, et al. Outpatient EHR-based diabetes clinical decision support that works: lessons learned from implementing Diabetes Wizard. Diabetes Spectrum. 2010;23(3):150-154
Results Reference
background
PubMed Identifier
26290886
Citation
Kharbanda EO, Nordin JD, Sinaiko AR, Ekstrom HL, Stultz JM, Sherwood NE, Fontaine PL, Asche SE, Dehmer SP, Amundson JH, Appana DX, Bergdall AR, Hayes MG, O'Connor PJ. TeenBP: Development and Piloting of an EHR-Linked Clinical Decision Support System to Improve Recognition of Hypertension in Adolescents. EGEMS (Wash DC). 2015 Jul 9;3(2):1142. doi: 10.13063/2327-9214.1142. eCollection 2015.
Results Reference
background
PubMed Identifier
22578085
Citation
Gilmer TP, O'Connor PJ, Sperl-Hillen JM, Rush WA, Johnson PE, Amundson GH, Asche SE, Ekstrom HL. Cost-effectiveness of an electronic medical record based clinical decision support system. Health Serv Res. 2012 Dec;47(6):2137-58. doi: 10.1111/j.1475-6773.2012.01427.x. Epub 2012 May 11.
Results Reference
background
PubMed Identifier
27044962
Citation
Hargraves I, LeBlanc A, Shah ND, Montori VM. Shared Decision Making: The Need For Patient-Clinician Conversation, Not Just Information. Health Aff (Millwood). 2016 Apr;35(4):627-9. doi: 10.1377/hlthaff.2015.1354.
Results Reference
background
PubMed Identifier
25670178
Citation
Agoritsas T, Heen AF, Brandt L, Alonso-Coello P, Kristiansen A, Akl EA, Neumann I, Tikkinen KA, Weijden Tv, Elwyn G, Montori VM, Guyatt GH, Vandvik PO. Decision aids that really promote shared decision making: the pace quickens. BMJ. 2015 Feb 10;350:g7624. doi: 10.1136/bmj.g7624.
Results Reference
background

Learn more about this trial

Chronic Kidney Disease Clinical Decision Support

We'll reach out to this number within 24 hrs