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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03473509
Other study ID # R34DK093992
Secondary ID
Status Completed
Phase N/A
First received March 9, 2018
Last updated March 20, 2018
Start date June 2013
Est. completion date March 2015

Study information

Verified date March 2018
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 746
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
CKD Registry
Health Service intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Outcome

Type Measure Description Time frame Safety issue
Primary Change in clinic systolic Change in ambulatory systolic BP measured at ambulatory clinic visits in the health care system. 12 months
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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