Primary Care CKD Registry

NCT03473509 | Completed

• 1 other identifier: R34DK093992
• Study Type: interventional
• Target: 746
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertension; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Change in clinic systolic

  Change in ambulatory systolic BP measured at ambulatory clinic visits in the health care system.

  12 months

Secondary Outcomes (4)

• Change in proportion of patients with BP control

  12 months

• Change in proportion fo patients with urine albuminuria quantification

  12 months

• Change in albuminuria severity

  12 months

• Change in proportion of patients with ACEi/ARB prescription

  12 months

Study Arms (2)

Chronic Kidney Disease (CKD) Registry

EXPERIMENTAL

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

Usual Care Registry

NO INTERVENTION

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.

Interventions

CKD Registry OTHER

Health Service intervention

Chronic Kidney Disease (CKD) Registry

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 22, 2018
• Study Start: June 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share