NCT02578628

Brief Summary

The Chronic Kidney Disease Engagement System is currently in place for 1700 adults receiving care from Empire Physicians Medical Group (EPMG), an Independent Practice Association located in Palm Desert, California. The system monitors routine clinical laboratory test results and send messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. This study will assess what happens to laboratory results, utilization of laboratory tests, and costs of care when ther system is discontinued.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

October 10, 2015

Last Update Submit

May 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Claims paid in past 12 months for covered services

    Total and breakdown by categories

    3 years

Secondary Outcomes (10)

  • Lipid test completed within time allotted per disease stage

    3 years

  • Estimated glomerular filtration

    3 years

  • Hemoglobin test completed within time allotted per disease stage

    3 years

  • Serum calcium test completed within time allotted per disease stage

    3 years

  • Serum phosphorus test completed within time allotted per disease stage

    3 years

  • +5 more secondary outcomes

Study Arms (2)

Active

ACTIVE COMPARATOR

These subjects will continue to receive Patient Engagement services.

Other: Patient Engagement

Control

NO INTERVENTION

These patients will have all Patient Engagement services discontinued.

Interventions

The patient engagement system monitors routine clinical laboratory test results and sends messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. Patients receive first class letters directing them to call their provider. Providers receive fax or electronic messages directing them to reach out to the patient to arrange follow-up care.

Active

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving services from Patient Engagement Services at randomization. CKD Stages 1, 2 or 3. Under the care of Empire Physicians Medical Group of Palm Desert, California.

You may not qualify if:

  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Empire Physicians Medical Group

Palm Desert, California, 92211, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin Littenberg, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 10, 2015

First Posted

October 19, 2015

Study Start

October 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations