Primary Care CKD Registry

• ClinicalTrials.gov Identifier: NCT03473509
• Recruitment Status: Completed
• First Posted: March 22, 2018
• Last Update Posted: March 22, 2018
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Chronic Kidney Diseases	Other: CKD Registry	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 746 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Impact of a Safety-Net Primary Care CKD Registry
• Actual Study Start Date: June 2013
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in clinic systolic [ Time Frame: 12 months ]
   Change in ambulatory systolic BP measured at ambulatory clinic visits in the health care system.

Secondary Outcome Measures :

1. Change in proportion of patients with BP control [ Time Frame: 12 months ]
   Change in the proportion of patients with BP control defined by BP <140/<90 mmHg at an ambulatory clinic visit.
2. Change in proportion fo patients with urine albuminuria quantification [ Time Frame: 12 months ]
   Change in proportion of patients whose albuminuria was quantified by a urine test among those had not received quantification at trial initiation.
3. Change in albuminuria severity [ Time Frame: 12 months ]
   Change in albuminuria severity (mg urine albumin/g urine creatinine) among those patients with albuminuria quantified at trial initiation
4. Change in proportion of patients with ACEi/ARB prescription [ Time Frame: 12 months ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03473509
• Other Study ID Numbers: R34DK093992 ( U.S. NIH Grant/Contract )
• First Posted: March 22, 2018
• Last Update Posted: March 22, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: data can be shared when requested by other individual researchers

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency