Study Stopped
Data source became unavailable
Discontinuation of Automated Engagement Support
1 other identifier
interventional
488
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
October 10, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedMay 8, 2018
May 1, 2018
2.3 years
October 10, 2015
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 COMPARATORThese subjects will continue to receive Patient Engagement services.
Control
NO INTERVENTIONThese 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.
Eligibility Criteria
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
- University of Vermontlead
- Patient Engagement Systemscollaborator
- Empire Physicians Medical Groupcollaborator
Study Sites (1)
Empire Physicians Medical Group
Palm Desert, California, 92211, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Littenberg, MD
University of Vermont
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