Aetna_Intel Medicare Home Biomonitoring Study

Congestive Heart Failure Clinical Trial

Official title:

Study of Impact of Home Biomonitoring With Nurse Case Manager Support for a Congestive Heart Failure Cohort, Compared to Case Manager Support Without Biomonitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105572
• Other study ID #: Biomonitoring099
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: April 15, 2010
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Aetna, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis is that use of Internet-connected home biomonitoring of weight, blood pressure and other indicators, in conjunction with nurse case management, will result in improved outcome for Medicare beneficiaries with with Congestive Heart Failure; compared to case management assistance without the biomonitoring device.

Description:

Goals of the Study:

• Demonstrate synergy between the Intel® Health Guide home biomonitoring and nurse case management. Measure positive impact on member engagement and clinical outcomes for members with Heart Failure.

• Quantify the potential to avoid costly re-hospitalization based on the Intel® Health Guide - enhanced case management interaction through early alerts and early intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Aetna Medicare (PFFS, HMO/PPO fully insured) Individual members, plus Medicare members from any plan sponsor that has agreed it would like its members to be included

• Member meets Aetna Health Profile Database criteria for Chronic Heart Failure (Disease Management Eligibility = Y) with a disease risk stratification score of 3 - 5 (moderately severe to severe). These proprietary criteria yield a group of individuals for whom historical claims data estimates a substantial risk of hospital readmission within the coming 6 months.

• Acute inpatient admission or 2 or more emergency room visits within 6 months prior to identification

• Residence in the designated geographic areas selected for the study (The planned source population is all New Jersey, New York, Pennsylvania and North Central Aetna Individual Medicare members and North Central. If members identified from these states have not filled the study within three months, the source population may be expanded to include Aetna's North Central region members in Illinois and Ohio. These North Central members would include all Aetna Medicare Individual members in these areas, plus any Group Medicare members from Groups whose Plan Sponsors agree that the study may be offered to the members.)

• Member may be currently open/ active in case management

• Responds telephonic outreach to offer study participation, or to Interactive Voice Response outreach call, and confirms each of:

• Their own identity {secure Health Insurance Portability Accountability Act (HIPAA) compliant acknowledgement to caller}

• That they have been told of having a heart condition

• Interest in hearing more and possibly participating in the study

Exclusion Criteria:

• Member had case management and this was closed within the 30 days prior to identification for the study

• End-of life, terminal cancer, end stage renal disease, hospice, late stage Alzheimer's disease, dementia, ventricular assist device, heart transplant or active in heart transplant program. Excluded diagnoses or conditions will be identified where it is evident through Aetna's Health Profile Data diagnoses in claims, or upon case management assessment.

• Chronic or ongoing intravenous heart failure medication

• Any response to Interactive Voice Response outreach call other than "Yes, I am interested"

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Intel Health Guide
An Internet-connected device with member-customized protocols and response algorithms. Participants interact with the Intel HealthGuide device, receiving immediate feedback, and also transmitting blood pressure, weights and responses to questions to a site monitored by their nurse case manager.

Other:
• Case Management
Specialized Medicare Case Managers review and coordinate services for members with multiple and complex needs with identified gaps in their care Medicare Case Management staff strives to enhance the member's quality of life, support continuity of care, facilitate provision of services in the appropriate setting and manage cost and resource allocation to promote quality, cost-effective outcomes. Specially trained Medicare Case Managers collaborate with the member, family, caregiver, member authorized representative, treating practitioner, health care provider, community services and other Aetna programs to coordinate care, with a focus on member education and maximizing quality outcomes.

Locations

Country	Name	City	State
United States	Aetna	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Aetna, Inc.	Intel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to acute hospital admission	During the 6 month intervention period, it is expected that the time from entering the study until the first primary event (acute hospital admission, emergency room visit or death) will be, on average, longer for those using the Intel® Health Guide with case management (HG-CM) than for those in the routine case management (Case Management-Only Group). The primary measure to be compared across the study groups will be the unadjusted hazard ratio.	6 months
Primary	Acute Hospital Admission, Emergency Room Visit or Death	It is expected that the proportion of members with an inpatient acute admission, emergency room visit, or death in the intervention period and follow-up periods will be lower in the HG-CM Group than the Case Management-Only Group.	6 months
Secondary	Decrease the number of acute hospital admissions and emergency room visits	Number of acute hospital admissions and emergency room visits will decrease during the 6 month intervention period and the number during the 3 months after the intervention period	6 months
Secondary	Number of Inpatient Hospital Days associated with Acute Admissions	Medicare members using the Intel® Health Guide are expected to have fewer Inpatient Acute Days in the intervention 6 months and during the 3 month follow-up period than do those in the Case Management-Only Group.	6 months
Secondary	Cardiovascular Admissions Decreased	Number of members with a hospital admission or emergency room visit for a cardiovascular DRG diagnosis in the intervention 6 months or during the 3 months' follow-up period will decrease	6 months