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Discontinuation of Automated Engagement Support

Primary Purpose

Chronic Kidney Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Engagement
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Patient refusal.

Sites / Locations

  • Empire Physicians Medical Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Active

Control

Arm Description

These subjects will continue to receive Patient Engagement services.

These patients will have all Patient Engagement services discontinued.

Outcomes

Primary Outcome Measures

Claims paid in past 12 months for covered services
Total and breakdown by categories

Secondary Outcome Measures

Lipid test completed within time allotted per disease stage
Estimated glomerular filtration
Hemoglobin test completed within time allotted per disease stage
Serum calcium test completed within time allotted per disease stage
Serum phosphorus test completed within time allotted per disease stage
Urine albumin-to-creatinine ratio test completed within time allotted per disease stage
Serum parathyroid hormone test completed within time allotted per disease stage
Serum albumin test completed within time allotted per disease stage
Serum electrolytes test completed within time allotted per disease stage
Latest LDL <100 mg/dl AND completed within time allotted per disease stage

Full Information

First Posted
October 10, 2015
Last Updated
May 2, 2018
Sponsor
University of Vermont
Collaborators
Patient Engagement Systems, Empire Physicians Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT02578628
Brief Title
Discontinuation of Automated Engagement Support
Official Title
Discontinuation of Automated Engagement Support
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Data source became unavailable
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Patient Engagement Systems, Empire Physicians Medical Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. 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. It has been used for over three years and appears to have improved adherence to Chronic Kidney Disease (CKD) treatment guidelines by influencing both patient and provider actions. EPMG wishes to restrict the service to those patients with advanced CKD and discontinue it for CKD stages 1-3. The investigators propose implementing this new policy in a randomized fashion with one half of the current early stage patients continuing to receive the service while the other half will no longer receive messages. The investigators will monitor laboratory results and health care utilization for both groups to determine what effect, if any, discontinuation has on quality of care. Human subjects will either continue to receive letters from the service when their tests are overdue or require additional clinical attention, or will no longer receive the service. All subjects will continue to receive care from their providers. The main outcomes include the frequency of recommended tests for CKD, the level of those tests, and utilization of health care services as indicated by claims data provided by EPMG. No additional data collection will occur beyond that which has been routinely done for clinical care. The study will continue for 36 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
These subjects will continue to receive Patient Engagement services.
Arm Title
Control
Arm Type
No Intervention
Arm Description
These patients will have all Patient Engagement services discontinued.
Intervention Type
Other
Intervention Name(s)
Patient Engagement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Claims paid in past 12 months for covered services
Description
Total and breakdown by categories
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Lipid test completed within time allotted per disease stage
Time Frame
3 years
Title
Estimated glomerular filtration
Time Frame
3 years
Title
Hemoglobin test completed within time allotted per disease stage
Time Frame
3 years
Title
Serum calcium test completed within time allotted per disease stage
Time Frame
3 years
Title
Serum phosphorus test completed within time allotted per disease stage
Time Frame
3 years
Title
Urine albumin-to-creatinine ratio test completed within time allotted per disease stage
Time Frame
3 years
Title
Serum parathyroid hormone test completed within time allotted per disease stage
Time Frame
3 years
Title
Serum albumin test completed within time allotted per disease stage
Time Frame
3 years
Title
Serum electrolytes test completed within time allotted per disease stage
Time Frame
3 years
Title
Latest LDL <100 mg/dl AND completed within time allotted per disease stage
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patient refusal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Littenberg, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Empire Physicians Medical Group
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Discontinuation of Automated Engagement Support

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