Aetna_Intel Medicare Home Biomonitoring Study

NCT01105572 | Completed

• 1 other identifier: Biomonitoring099
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Decrease the number of acute hospital admissions and emergency room visits

  6 months

• Number of Inpatient Hospital Days associated with Acute Admissions

  6 months

• Cardiovascular Admissions Decreased

  6 months

Study Arms (2)

Intel Home Health Guide

EXPERIMENTAL

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

Case Management Only

NO INTERVENTION

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

Interventions

Intel Health Guide DEVICE

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.

Intel Home Health Guide

Case Management OTHER

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.

Case Management Only

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• Aetna, Inc.: lead
• Intel Corporation: collaborator

Study Sites (1)

Aetna

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Case Management

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Marcia Wade, MD

  Aetna, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: November 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 16, 2010

Record last verified: 2010-04

Locations

US (1)