Clinical trial NCT02578628: Discontinuation of Automated Engagement Support
Official title: Discontinuation of Automated Engagement Support
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Patient Engagement Systems
name: Empire Physicians Medical Group
First posted: 2015-10-19
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Claims paid in past 12 months for covered services
timeFrame: 3 years
Secondary outcomes:
measure: Lipid test completed within time allotted per disease stage
timeFrame: 3 years
measure: Estimated glomerular filtration
timeFrame: 3 years
measure: Hemoglobin test completed within time allotted per disease stage
timeFrame: 3 years
measure: Serum calcium test completed within time allotted per disease stage
timeFrame: 3 years
measure: Serum phosphorus test completed within time allotted per disease stage
timeFrame: 3 years
measure: Urine albumin-to-creatinine ratio test completed within time allotted per disease stage
timeFrame: 3 years
measure: Serum parathyroid hormone test completed within time allotted per disease stage
timeFrame: 3 years
measure: Serum albumin test completed within time allotted per disease stage
timeFrame: 3 years
measure: Serum electrolytes test completed within time allotted per disease stage
timeFrame: 3 years
measure: Latest LDL <100 mg/dl AND completed within time allotted per disease stage
timeFrame: 3 years
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Empire Physicians Medical Group
state: California
Study officials:
affiliation: University of Vermont
name: Benjamin Littenberg, MD
role: PRINCIPAL_INVESTIGATOR
References: