Chronic Kidney DiseasesCKD-CDSNCT03890588
Chronic Kidney Disease Clinical Decision Support
A study testing CKD enhanced clinical decision support in people with Chronic Kidney Diseases and Hypertension, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension, Diabetes
- What is being tested?
- CKD enhanced clinical decision support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,295 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Care System
Bloomington, Minnesota, 55425
About this study
Official title: A Technology-Driven Intervention to Improve Identification and Management of Chronic Kidney Disease in Primary Care
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.
Read the 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
- Being tested
- CKD enhanced clinical decision support
- Keywords
- Chronic Kidney Disease, CKD, Clinical Decision Support, Diabetes, Hypertension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD enhanced clinical decision supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With CKD Diagnosis
Number of patients who had a CKD diagnosis document in the 18 months post index.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18-month period post index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start17 Apr 2019
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinic level cluster randomized study
- Masking
- None (open label)
- Enrolment
- 6,295 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JoAnn M Sperl-Hillen, MD, Principal investigator, Senior Investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890588
- Sponsor's protocol ID
- A17-353
- Other IDs
- 1R18DK118463-01
- Acronym
- CKD-CDS
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2019
- Last updated
- 1 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11904577Inker 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.
PubMed 24647050Stevens 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.
PubMed 23732715Whelton 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.
PubMed 29146535Andrade 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.
PubMed 15298234Grant 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.
PubMed 14984450Phillips 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.
PubMed 16186262van 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.
PubMed 28207923O'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.
PubMed 21242556Sperl-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
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.
PubMed 26290886Gilmer 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.
PubMed 22578085Hargraves 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.
PubMed 27044962Agoritsas 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.
PubMed 25670178Sperl-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.
PubMed 38435072
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-Driven Intervention to Improve Identification and Management of Chronic Kidney Disease in Primary Care
- ClinicalTrials.gov ID
- NCT03890588
- Acronym / sponsor ID
- CKD-CDS / A17-353
- Conditions
- Chronic Kidney Diseases, Hypertension, Diabetes
- Keywords
- Chronic Kidney Disease, CKD, Clinical Decision Support, Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,295 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Posted 1 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinic level cluster randomized study
| Arm | Type | Receives |
|---|---|---|
| CKD enhanced clinical decision support (CKD-CDS Intervention) | Experimental | Other: CKD enhanced clinical decision supportPriority 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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from receiving the
- Patients enrolled in hospice,
- Patients with active cancer or undergoing chemotherapy
- Patients with pregnancy in the last year
- Patients with end stage renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD enhanced clinical decision supportThe 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. | Other | CKD enhanced clinical decision support (CKD-CDS Intervention) |
Primary outcome
Number of Participants With CKD Diagnosis
Time frame: 18-month period post index
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)
Time frame: 18-month period post index
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
Time frame: 18-month period post index
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
Time frame: 1 to 18-month period post index
Number of patients whose last A1c was <7% in the 1-18 months post index.
Number of Patients With Referral to Nephrology
Time frame: 18-month period post index
Number of patients who have a referral to nephrology in the 18 months post index.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11904577National 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.
- Background: PubMed 24647050Inker 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.
- Background: PubMed 23732715Stevens 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.
- Background: PubMed 29146535Whelton 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.
- Background: PubMed 15298234Andrade 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.
- Background: PubMed 14984450Grant 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.
- Background: PubMed 16186262Phillips 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.
- Background: PubMed 28207923van 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.
- Background: PubMed 21242556O'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.
- BackgroundSperl-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: PubMed 26290886Kharbanda 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.
- Background: PubMed 22578085Gilmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JoAnn M Sperl-Hillen, MD principal investigator
Senior Investigator, HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CKD enhanced clinical decision support in people with Chronic Kidney Diseases and Hypertension, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With CKD Diagnosis (time frame: 18-month period post index). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890588, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.