Primary Care CKD Registry

Impact of a Safety-Net Primary Care CKD Registry

This study examines whether a safety-net primary care CKD registry directed at the entire primary care team can enhance the delivery of guideline concordant CKD care, including BP control, ACEi/ARB use and albuminuria quantification.

Study Overview

• Status: Completed
• Conditions: Hypertension; Chronic Kidney Diseases
• Intervention / Treatment: Other: CKD Registry

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All PCPs who worked in practice teams and provided longitudinal primary care to patients were eligible to participate in this study. Practice teams that consisted of several physicians (+/- trainees), one nurse, nurse practitioners, medical assistants and behaviorists, were randomized 1:1 to one of two arms with a random number generator: access to an electronic CKD registry or a usual care registry for 12 months.

Exclusion Criteria:

PCPs who solely provided specialty care, for example HIV services or urgent care, were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chronic Kidney Disease (CKD) Registry; The CKD registry provided primary care practice teams with point-of-care data about patient-specific CKD status, recent ambulatory clinic blood pressure (BP) readings, status of Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) prescription, and quantification of albuminuria (UACR). It also provided data about diabetes care, immunization status, and data pertinent to age appropriate cancer screening, to align with usual care. Point-of-care decision support reminded primary care providers (PCPs) about guideline concordant care for individuals with CKD. Quarterly feedback to practice teams and individual PCPs identified patients with CKD and BP >140/90 mmHg, those not prescribed an ACEi/ARB, and those with albuminuria.	Other: CKD Registry; Health Service intervention
No Intervention: Usual Care Registry; Usual care consisted of an electronic registry that was in use before trial implementation. It provided practice teams with point-of-care data about diabetes care, age-appropriate cancer screening and immunizations, but no CKD-related data. Medical assistants were encouraged to use the usual care registry to identify patients who were due for cancer screening or immunizations. Quarterly feedback was not provided for practice teams randomized to receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinic systolic	Change in ambulatory systolic BP measured at ambulatory clinic visits in the health care system.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in proportion of patients with BP control	Change in the proportion of patients with BP control defined by BP <140/<90 mmHg at an ambulatory clinic visit.	12 months
Change in proportion fo patients with urine albuminuria quantification	Change in proportion of patients whose albuminuria was quantified by a urine test among those had not received quantification at trial initiation.	12 months
Change in albuminuria severity	Change in albuminuria severity (mg urine albumin/g urine creatinine) among those patients with albuminuria quantified at trial initiation	12 months
Change in proportion of patients with ACEi/ARB prescription	Change in proportion of patients prescribed an ACEi/ARB in the clinical record or had a documented reason for no prescription (i.e., allergy, prior development of hyperkalemia, or acute kidney injury)	12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: R34DK093992 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: data can be shared when requested by other individual researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No