Discontinuation of Automated Engagement Support

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Patient Engagement

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.

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palm Desert, California, United States, 92211
      • Empire Physicians Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active; These subjects will continue to receive Patient Engagement services.	Other: Patient Engagement; 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.
NO_INTERVENTION: Control; These patients will have all Patient Engagement services discontinued.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Claims paid in past 12 months for covered services	Total and breakdown by categories	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Urine albumin-to-creatinine ratio test completed within time allotted per disease stage	3 years
Serum parathyroid hormone test completed within time allotted per disease stage	3 years
Serum albumin test completed within time allotted per disease stage	3 years
Serum electrolytes test completed within time allotted per disease stage	3 years
Latest LDL <100 mg/dl AND completed within time allotted per disease stage	3 years

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: Patient Engagement Systems; Empire Physicians Medical Group

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): December 31, 2017

Study Registration Dates

• First Submitted: October 10, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (ESTIMATE): October 19, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 15-453