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Primary Care CKD Registry

Primary Purpose

Hypertension, Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CKD Registry
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Chronic Kidney Disease (CKD) Registry

    Usual Care Registry

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.
    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.
    Change in albuminuria severity
    Change in albuminuria severity (mg urine albumin/g urine creatinine) among those patients with albuminuria quantified at trial initiation
    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)

    Full Information

    First Posted
    March 9, 2018
    Last Updated
    March 20, 2018
    Sponsor
    University of California, San Francisco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03473509
    Brief Title
    Primary Care CKD Registry
    Official Title
    Impact of a Safety-Net Primary Care CKD Registry
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (Actual)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Chronic Kidney Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    746 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Chronic Kidney Disease (CKD) Registry
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care Registry
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    CKD Registry
    Intervention Description
    Health Service intervention
    Primary Outcome Measure Information:
    Title
    Change in clinic systolic
    Description
    Change in ambulatory systolic BP measured at ambulatory clinic visits in the health care system.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change in proportion of patients with BP control
    Description
    Change in the proportion of patients with BP control defined by BP <140/<90 mmHg at an ambulatory clinic visit.
    Time Frame
    12 months
    Title
    Change in proportion fo patients with urine albuminuria quantification
    Description
    Change in proportion of patients whose albuminuria was quantified by a urine test among those had not received quantification at trial initiation.
    Time Frame
    12 months
    Title
    Change in albuminuria severity
    Description
    Change in albuminuria severity (mg urine albumin/g urine creatinine) among those patients with albuminuria quantified at trial initiation
    Time Frame
    12 months
    Title
    Change in proportion of patients with ACEi/ARB prescription
    Description
    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)
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.

    12. IPD Sharing Statement

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

    Learn more about this trial

    Primary Care CKD Registry

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