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CompletedNCT03473509Updated Mar 22, 2018

Primary Care CKD Registry

An interventional study of CKD Registry in Hypertension and Chronic Kidney Diseases, sponsored by University of California, San Francisco. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-22.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
746
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
  • Chronic Kidney Diseases
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
746 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherCKD Registry

    Health Service intervention

05

What researchers measure

Primary outcomes

  1. Change in clinic systolic

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

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. Change in albuminuria severity

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

    Time frame: 12 months

  4. 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)

    Time frame: 12 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — data can be shared when requested by other individual researchers

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03473509
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Mar 22, 2018
Start date
Jun 2013
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Mar 22, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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