Evaluation of an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care

NCT02925962 | Completed

• 1 other identifier: CP2016R18
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

Brief 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 will evaluate whether a CDSS plus a follow-up telephone call from a pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP level, with secondary outcomes related to processes of care and patient knowledge.

Conditions

Hypertension; Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure from enrollment

  Clinical Outcome: The primary clinical outcome of the trial is change in blood pressure (mmHg) from enrollment to the end of the follow up period as a continuous outcome, ascertained from the electronic medical record. BP measures from the clinical record will be ascertained in no more than quarterly intervals in the primary care setting to avoid bias by ascertainment. Investigators will also consider the dichotomous clinical outcome "achieved sustained BP control", defined as BP \< 140/90 mmHg in ≥ two consecutive visits during the trial.

  Investigators will follow patients up to 2 years after measures

Secondary Outcomes (3)

• Feasibility

  Investigators will follow patients up to 2 years after measures

• Processes of Care

  Investigators will follow patients up to 2 years after measures

• CKD and NSAID avoidance Knowledge

  Investigators will interview each participant 2 weeks after their primary care visit or clinical pharmacist phone call

Study Arms (3)

Clinical Decision Support System (CDSS)

EXPERIMENTAL

PCPs get a notice the CKD Clinical Decision Support System (CDSS) is available. CDSS overview: * The study MDs order CKD triple marker tests * Patients will go to the lab as per usual clinical care * Lab results are returned to PCPs clinical results folder as per usual clinical workflow with information about CKD and link to KDIGO guidelines * Results will also be sent to the Study MD's for monitoring * At the patient's next visit, if the labs are completed, the full CDSS launches for the PCP * If the labs are not completed by the next visit, a Best Practice Alert (BPA) will launch for the PCP notifying them that the labs have been ordered, but the patient hasn't done them yet

Other: Clinical Decision Support System (CDSS)

Clinic Decision Sup System + Pharmacist

EXPERIMENTAL

The Clinical Decision Support System + Pharmacist follow-up call extends beyond the CDSS alone. CDSS Plus overview: * At the visit in which the CDSS launches, the PCP will hand a study card with pharmacist information to their patient notifying them that a pharmacist will be calling to follow-up after the visit * The pharmacist will use MyChart and/or phone calls to schedule a follow-up call within two weeks of the visit * On the follow-up phone call, the pharmacist will discuss understanding of CKD, medication review and adherence assessment, home BP checks, and the importance of NSAID avoidance * A second follow-up call will only be scheduled if the patient is non-adherent with their medications and makes an active plan for adherence with the pharmacist, or if the patient requests an additional call from the pharmacist

Other: Clinic Decision Sup System + Pharmacist

Usual Care

NO INTERVENTION

Patients continue to receive usual care by their provider.

Interventions

Clinical Decision Support System (CDSS) OTHER

A targeted, automated CKD clinical decision support system (CDSS) designed to improve bloodpressure (BP) level, disease awareness, staging, processes of care, and knowledge among persons with documented reduced eGFRcreat (creatinine-based estimated glomerular filtration rate) in primary care setting.

Clinical Decision Support System (CDSS)

Clinic Decision Sup System + Pharmacist OTHER

Includes everything in the CDSS intervention but adds a follow-up call from a pharmacist, who is part of the clinical team. The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings.

Also known as: CDSS Plus, Clinical Decision Support System + Pharmacist

Clinic Decision Sup System + Pharmacist

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• Patients actively and recently seen by nephrology clinic (at least once in the past 12 months)
• 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 for specific patients in their panel due to not believing this person should be included in the study for any reason.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Division of General Internal Medicine

San Francisco, California, 94115, United States

Location

Related Publications (6)

• Coresh J, Byrd-Holt D, Astor BC, Briggs JP, Eggers PW, Lacher DA, Hostetter TH. Chronic kidney disease awareness, prevalence, and trends among U.S. adults, 1999 to 2000. J Am Soc Nephrol. 2005 Jan;16(1):180-8. doi: 10.1681/ASN.2004070539. Epub 2004 Nov 24.

  PMID: 15563563 RESULT

• Peralta CA, Shlipak MG, Judd S, Cushman M, McClellan W, Zakai NA, Safford MM, Zhang X, Muntner P, Warnock D. Detection of chronic kidney disease with creatinine, cystatin C, and urine albumin-to-creatinine ratio and association with progression to end-stage renal disease and mortality. JAMA. 2011 Apr 20;305(15):1545-52. doi: 10.1001/jama.2011.468. Epub 2011 Apr 11.

  PMID: 21482744 RESULT

• Shlipak MG, Coresh J, Gansevoort RT. Cystatin C versus creatinine for kidney function-based risk. N Engl J Med. 2013 Dec 19;369(25):2459. doi: 10.1056/NEJMc1312801. No abstract available.

  PMID: 24350959 RESULT

• 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 RESULT

• Peralta CA, Livaudais-Toman J, Stebbins M, Lo L, Robinson A, Pathak S, Scherzer R, Karliner LS. Electronic Decision Support for Management of CKD in Primary Care: A Pragmatic Randomized Trial. Am J Kidney Dis. 2020 Nov;76(5):636-644. doi: 10.1053/j.ajkd.2020.05.013. Epub 2020 Jul 22.

  PMID: 32682696 DERIVED

• Khoong EC, Karliner L, Lo L, Stebbins M, Robinson A, Pathak S, Santoyo-Olsson J, Scherzer R, Peralta CA. A Pragmatic Cluster Randomized Trial of an Electronic Clinical Decision Support System to Improve Chronic Kidney Disease Management in Primary Care: Design, Rationale, and Implementation Experience. JMIR Res Protoc. 2019 Jun 7;8(6):e14022. doi: 10.2196/14022.

  PMID: 31199334 DERIVED

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Interventions

Pharmacists

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; 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

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Design

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

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 6, 2016
• Study Start: August 14, 2017
• Primary Completion: October 4, 2018
• Study Completion: June 30, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)