Early Identification and Action in CKD

NCT02208674 | Completed DMC

• 1 other identifier: 2014-0251
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is screened and treated according to recommended guidelines. Using a cluster-randomized, controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize 6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a pharmacist-directed "CKD Action Plan" (group 2). Determining the impact of the CKD Action Plan on screening and treatment guideline adherence is the primary goal of this pilot study.

Conditions

Chronic Kidney Disease; Hypertension

Keywords

chronic kidney disease; albuminuria; hypertension; dyslipidemia; cardiovascular disease; pragmatic trial; cluster randomized trial

Outcome Measures

Primary Outcomes (1)

• Screening Urinary Albumin Excretion

  Completed test for urine albumin/creatinine (or urine protein/creatinine)

  At 12 months

Secondary Outcomes (10)

• Dyslipidemia Screening

  At least once after eGFR < 60 ml/min

• ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic)

  within 12 months of enrollment date

• Statin Treatment

  Within 12 months of enrollment

• Blood Pressure Control-1

  Average of last two readings prior to 12 months post-enrollment

• Blood Pressure--II

  Average of all blood pressures within 12 month study period

Study Arms (2)

Usual Care

NO INTERVENTION

Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care.

Protocolized, pharmacist-delivered CKD Action Plan

EXPERIMENTAL

Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations.

Other: Protocolized, pharmacist-delivered CKD Action Plan

Interventions

Protocolized, pharmacist-delivered CKD Action Plan OTHER

The CKD Action plan protocolizes the screening and treatment of primary risk factors for CKD progression and cardiovascular disease among individuals with stage G3A CKD

Also known as: Health care delivery procedure

Protocolized, pharmacist-delivered CKD Action Plan

Eligibility Criteria

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

You may qualify if:

• years of age or older
• eGFRCR value between 45-59 ml/min/1.73m2 in the prior 12 months
• scheduled laboratory appointment for serum creatinine testing within the next 30 days
• average systolic or diastolic blood pressure reading of at least 150 or 85 mm Hg, respectively, during the prior 12 months.

You may not qualify if:

• fewer than 2 blood pressure readings in the prior 12 months,
• pregnancy
• current hospitalization
• life expectancy less than 6 months as determined by the study investigators

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Related Publications (1)

• Chang AR, Evans M, Yule C, Bohn L, Young A, Lewis M, Graboski E, Gerdy B, Ehmann W, Brady J, Lawrence L, Antunes N, Green J, Snyder S, Kirchner HL, Grams M, Perkins R. Using pharmacists to improve risk stratification and management of stage 3A chronic kidney disease: a feasibility study. BMC Nephrol. 2016 Nov 8;17(1):168. doi: 10.1186/s12882-016-0383-7.

  PMID: 27825313 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Albuminuria; Dyslipidemias; Cardiovascular Diseases

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; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alex Chang, MD, MS

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: August 5, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)