Aetna_Intel Medicare Home Biomonitoring Study

This study has been completed.
Sponsor:
Collaborator:
Intel Corporation
Information provided by:
Aetna, Inc.
ClinicalTrials.gov Identifier:
NCT01105572
First received: April 15, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Device: Intel Health Guide
Other: Case Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Aetna, Inc.:

Primary Outcome Measures:
  • Time to acute hospital admission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Acute Hospital Admission, Emergency Room Visit or Death [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Decrease the number of acute hospital admissions and emergency room visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Number of Inpatient Hospital Days associated with Acute Admissions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Cardiovascular Admissions Decreased [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Enrollment: 316
Study Start Date: November 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intel Home Health Guide
Participants in the intervention group will receive the use of the Intel Healthguide, an Internet-connected device with member-customized protocols and response algorithms. Participants interact with the Intel HealthGuide device, receiving immediate feedback when transmitting blood pressure, weights and responses to questions to a site monitored by their nurse case manager. 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.
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 Name: Intel Health Guide
No Intervention: Case Management Only
All participants in the comparison group, are identified for outreach and assistance by a nurse case manager. 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.
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.

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105572

Locations
United States, New Jersey
Aetna
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Aetna, Inc.
Intel Corporation
Investigators
Principal Investigator: Marcia Wade, MD Aetna, Inc.
  More Information

No publications provided

Responsible Party: Marcia Wade, Aetna, Inc
ClinicalTrials.gov Identifier: NCT01105572     History of Changes
Other Study ID Numbers: Biomonitoring099
Study First Received: April 15, 2010
Last Updated: April 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Aetna, Inc.:
Congestive Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014