Chronic Kidney Disease Clinical Decision Support

NCT03890588 | Completed Results DMC

• 2 other identifiers: A17-3531R18DK118463-01
• Study Type: interventional
• Target: 6,295
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Hypertension; Diabetes

Keywords

Chronic Kidney Disease; CKD; Clinical Decision Support; Diabetes; Hypertension

Outcome Measures

Primary Outcomes (5)

• Number of Participants With CKD Diagnosis

  Number of patients who had a CKD diagnosis document in the 18 months post index.

  18-month period 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.

  18-month period 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.

  18-month period post index

• Number of Patients With Optimal Glucose Control

  Number of patients whose last A1c was \<7% in the 1-18 months post index.

  1 to 18-month period post index

• Number of Patients With Referral to Nephrology

  Number of patients who have a referral to nephrology in the 18 months post index.

  18-month period post index

Study Arms (2)

CKD enhanced clinical decision support (CKD-CDS Intervention)

EXPERIMENTAL

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.

Other: CKD enhanced clinical decision support

Usual Care

NO INTERVENTION

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.

Interventions

CKD enhanced clinical decision support 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.

CKD enhanced clinical decision support (CKD-CDS Intervention)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

HealthPartners Care System

Bloomington, Minnesota, 55425, United States

Location

Related Publications (15)

• 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.

  PMID: 11904577 BACKGROUND

• 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.

  PMID: 24647050 BACKGROUND

• 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.

  PMID: 23732715 BACKGROUND

• 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.

  PMID: 29146535 BACKGROUND

• 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.

  PMID: 15298234 BACKGROUND

• 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.

  PMID: 14984450 BACKGROUND

• 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.

  PMID: 16186262 BACKGROUND

• 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.

  PMID: 28207923 BACKGROUND

• 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.

  PMID: 21242556 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26290886 BACKGROUND

• 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.

  PMID: 22578085 BACKGROUND

• 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.

  PMID: 27044962 BACKGROUND

• 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.

  PMID: 25670178 BACKGROUND

• Sperl-Hillen J, Crain AL, Wetmore JB, Chumba LN, O'Connor PJ. A CKD Clinical Decision Support System: A Cluster Randomized Clinical Trial in Primary Care Clinics. Kidney Med. 2023 Dec 12;6(3):100777. doi: 10.1016/j.xkme.2023.100777. eCollection 2024 Mar.

  PMID: 38435072 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Some Usual Care (UC) participants received CDS for BP and A1c management due to existing CDS pre-dating the study. Due to Corona Virus Disease 2019 (COVID-19), the study paused 5 months, and there were fewer office visits, which would have limited intervention exposure. The intervention didn't allow for video visit screen sharing, a visit type that increased in the pandemic. There was a potential learning effect contamination due to some clinicians caring for patients in both study arms.

Results Point of Contact

• Title: JoAnn Sperl-Hillen, MD, Senior Clinical Investigator
• Organization: HealthPartners Institute

joann.m.sperlhillen@healthpartners.com

952-967-5009

Study Officials

• JoAnn M Sperl-Hillen, MD

  Senior Investigator, HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinic level cluster randomized study

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 26, 2019
• Study Start: April 17, 2019
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: December 1, 2022
• Results First Posted: December 1, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)