Discontinuation of Automated Engagement Support

Chronic Kidney Disease Clinical Trial

Official title:

Discontinuation of Automated Engagement Support

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02578628
• Other study ID #: 15-453
• Status: Terminated
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2018
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 488
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Empire Physicians Medical Group	Palm Desert	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Vermont	Empire Physicians Medical Group, Patient Engagement Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Claims paid in past 12 months for covered services	Total and breakdown by categories	3 years
Secondary	Lipid test completed within time allotted per disease stage		3 years
Secondary	Estimated glomerular filtration		3 years
Secondary	Hemoglobin test completed within time allotted per disease stage		3 years
Secondary	Serum calcium test completed within time allotted per disease stage		3 years
Secondary	Serum phosphorus test completed within time allotted per disease stage		3 years
Secondary	Urine albumin-to-creatinine ratio test completed within time allotted per disease stage		3 years
Secondary	Serum parathyroid hormone test completed within time allotted per disease stage		3 years
Secondary	Serum albumin test completed within time allotted per disease stage		3 years
Secondary	Serum electrolytes test completed within time allotted per disease stage		3 years
Secondary	Latest LDL <100 mg/dl AND completed within time allotted per disease stage		3 years