Clinical trial NCT01105572: Aetna_Intel Medicare Home Biomonitoring Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Lead sponsor: Aetna, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Intel Corporation
First posted: 2010-04-16
Enrollment: 316
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed 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.

Eligibility criteria: 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"

Primary outcomes:
measure: Time to acute hospital admission
timeFrame: 6 months
measure: Acute Hospital Admission, Emergency Room Visit or Death
timeFrame: 6 months
Secondary outcomes:
measure: Decrease the number of acute hospital admissions and emergency room visits
timeFrame: 6 months
measure: Number of Inpatient Hospital Days associated with Acute Admissions
timeFrame: 6 months
measure: Cardiovascular Admissions Decreased
timeFrame: 6 months
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Aetna
state: New Jersey
Study officials:
affiliation: Aetna, Inc.
name: Marcia Wade, MD
role: PRINCIPAL_INVESTIGATOR
References: