Early Identification and Action in CKD

NCT ID: NCT02208674

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease Hypertension

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Protocolized, pharmacist-delivered CKD Action Plan

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

Group Type EXPERIMENTAL

Protocolized, pharmacist-delivered CKD Action Plan

Intervention Type 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

Interventions

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Protocolized, pharmacist-delivered CKD Action Plan

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

Intervention Type OTHER

Other Intervention Names

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Health care delivery procedure

Eligibility Criteria

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Inclusion Criteria

* 18 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Geisinger Clinic

OTHER

Sponsor Role lead

Responsible Party

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Alexander Chang

Clinical Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alex Chang, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

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Geisinger Health System

Danville, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27825313 (View on PubMed)

Related Links

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Other Identifiers

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2014-0251

Identifier Type: -

Identifier Source: org_study_id