The primary objective of this telephonic heart failure specific patient education study is
to assess the incremental clinical, psycho-social, and functional lifestyle benefits of the
Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease
Management Program/Study) when added to standard care among veteran beneficiaries with a
heart failure diagnosis. A secondary objective is to assess the impact of the Health E
Heart Study on total system utilization costs.
CHF is one of the most common diagnoses for Department of Veterans Affairs (VA) patients.
Cost of care, particularly inpatient hospitalization, is high dollar expenditure in the
Study subjects, recruited from the enrolled patient population of the STVHCS, are identified
by a diagnosis of CHF in VA clinical databases. Administrative and clinical inclusion and
exclusion criteria will be applied by review of medical records. Subjects who appear to
meet inclusion criteria will be mailed a pre-enrollment letter containing an Information
Sheet describing the program. A follow-up phone call by an RN will go over the program in
detail, review the Information Sheet, and initiate enrollment if the subject wishes to
participate. As a less than minimal risk study, verbal consent or refusal will be
documented in the respective subject's computerized medical record. Assenting subjects will
be randomized by the last digit of the social security (odd and even) in a 1:1 ratio to the
control group (standard care at STVHCS) or the intervention group (receiving the telephonic
disease management services in addition to standard care). The intervention group will
receive a telephonic intervention for one year that consists of formal scheduled nurse
telephone education sessions, 24-hour access to a nurse counseling and symptom advice
telephone line, printed action plans, workbooks, and individualized assessment letters,
medication compliance reminders, vaccination reminders, and physician alerts about signs and
symptoms of decompensation. Once enrolled, the RN conducts a telephonic assessment at
intake, 6, and 12 months to assess each participant's knowledge, behavior, and health status
related to the HF condition.
All subjects enrolled in the study will continue to receive comprehensive heart failure care
from the STVHCS with those subjects randomized to the program receiving the additional
telephonic intervention. Risk stratification is determined from a combination of review of
the medical record patient admission history, and other self-reported information. Factors
considered include: Goldman Specific Activity Scale, self-management practices, medical
history, medical management, and psychosocial factors. The algorithm employs Boolean logic
and sorts patients into one of three categories that determines the frequency of scheduled
calls over the course of the year. The communications to physicians occurs through the VA
CPRS system regularly, usually after each scheduled patient call. Pre-specific clinical,
process, and economic outcomes will be collected on all subjects and analyzed at 6 and 12
Comparisons: The study will compare resources consumed in providing care to patients with
heart failure post-randomization receiving standard care with resources consumed with
standard care supplemented by the Health E Heart Disease Management Program. The study will
measure direct VA medical care costs.
Study subjects will all receive comprehensive medical care for congestive heart failure from
the STVHCS. Experimental subjects will receive additional telephone calls, patient
education sessions, customized treatment and self-management plans, and written patient
education materials. All subjects will receive telephonic assessments of health status, and
functional status at 6 and 12 months after randomization.
Inclusion criteria are designed to enroll a population of VA patients with moderate-severe
heart failure who are expected to be reasonably representative of and generalizable to
potential candidates for the Health E Heart Disease Management Program intervention. To be
eligible for the study, veteran beneficiaries must:
- Be 18 years of age
- Have a diagnosis of heart failure
- Have received care in urgent care or have been hospitalized, or have more than 12
outpatient visits in the last twelve months.
- Speak either English or Spanish.
Exclusion criteria are designed to exclude persons who are unable to participate in the
intervention, whose mortality or health care utilization are driven by co-morbid
conditions, or who are enrolled in other research.
- End-stage renal disease on chronic dialysis
- Prior heart transplant
- End-stage or terminal illness in addition to heart failure, such as metastatic
malignancy or AIDS with anticipated life expectancy less than 6 months.
- Residence in a nursing home
- Currently participating in another research or care management program.
- No access to a telephone
- Severe dementia